Welcome » May 14, 2024 12:37 PM

Program Name:	BadgerCare Plus and Medicaid	Handbook Area:	Pharmacy
05/14/2024

Prior Authorization : Preferred Drug List

Topic #1999

A Brief Overview of the Preferred Drug List

ForwardHealth makes recommendations to the Wisconsin Medicaid Pharmacy PA Advisory Committee on whether certain PDL drugs should be preferred or non-preferred. These recommendations are based primarily on objective evaluations of a drug's relative safety, effectiveness, clinical outcomes, and relative cost (to Wisconsin Medicaid) in comparison with other therapeutically interchangeable alternative agents in the same drug class.

New drugs are usually added to existing drug classes on the PDL as non-preferred drugs until their next scheduled class review by the Wisconsin Medicaid Pharmacy PA Advisory Committee.

The PDL is not a drug formulary and is not a comprehensive list of covered drugs.

Drugs and drug classes on the PDL are covered fee for service. Certain drugs may have restrictions (for example, diagnosis, quantity limits, age limits).

Prescribers are encouraged to write prescriptions for preferred drugs if medically appropriate. Non-preferred drugs may be covered with an approved PA request. Most preferred drugs do not require PA, except in designated classes identified on the Preferred Drug List Quick Reference.

Topic #10937

A Pharmacy Provider's Responsibilities for Prior Authorization for Preferred Drug List Drugs

Pharmacy providers should review the Preferred Drug List Quick Reference for the most current list of preferred and non-preferred drugs.

When a pharmacy provider receives a prescription for a non-preferred drug, the pharmacy provider is encouraged to contact the prescriber to discuss preferred drug options. The prescriber may choose to change the prescription to a preferred drug, or if the non-preferred drug is medically necessary for the member, the prescriber must complete the appropriate PA form.

Pharmacy providers are required to submit PA requests using the completed, signed, and dated PA form from the prescriber and a completed PA/RF.

Pharmacy providers may submit PA requests using the STAT-PA system (when applicable), on the Portal, by fax, or by mail.

Pharmacy providers must retain a completed, signed, and dated copy of the PA form and any supporting documentation received from the prescriber. Pharmacy providers may not reuse PA forms from previously approved PA requests for subsequent PA request submissions.

Note: If additional information needs to be addressed and can be provided by the pharmacy provider (for example, medication refill history and compliance), the pharmacy provider should add the information to the Prior Authorization Fax Cover Sheet or to the Additional Information section available on most PA forms. The pharmacy provider must sign and date the entry to clearly identify the information source.

Topic #1987

A Prescriber's Responsibilities for Prior Authorization for Preferred Drug List Drugs

Prescribers are encouraged to write prescriptions for preferred drugs.

Prescribers are encouraged to prescribe more than one preferred drug before a non-preferred drug is prescribed from the same drug class.

Prescribers must complete, sign, and date the appropriate PA form for drugs on the Preferred Drug List Quick Reference that require PA.

Prescribers must include all the required clinical information about the member's medical history on the PA form. The prescriber's signature on the PA form attests that the information provided is complete and accurate.

For information about general ForwardHealth PA policy for drugs that require PA approval, prescribers and pharmacy providers may refer to the Standard Pharmacy Policy for Covered and Noncovered Drugs topic. Providers may also refer to this topic for information about what may not be considered criteria to support the need for a drug.

Completing a PA Form

If a non-preferred drug or a preferred drug that requires clinical PA is medically necessary for a member, the prescriber must complete, sign, and date the appropriate PA form for that drug. When completing the PA form, prescribers are required to provide a handwritten signature on the form.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Prescribers are required to retain a completed, signed, and dated copy of the PA form and any supporting documentation. Pharmacy providers may not reuse PA forms from previously approved PA requests for subsequent PA request submissions.

Topic #15037

Alzheimer's Agents

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Memantine Products

Because the safety and effectiveness of all memantine products for pediatric patients has not been established, coverage will be restricted to adult members who are 18 years of age or older.

ForwardHealth will not cover memantine products for members 17 years of age or younger. PA requests submitted for memantine products for members 17 years of age or younger will be returned as a noncovered service. Members do not have appeal rights for noncovered services.

Memantine Products Policy Exceptions

BadgerCare Plus, Medicaid, and SeniorCare members who were 44 years of age or younger and were taking memantine (as identified from drug paid claims history) prior to February 15, 2013, were allowed to continue receiving memantine or memantine XR products without PA. Those members who remained eligible in 2023 to receive memantine products without PA will no longer be eligible to continue receiving memantine products without PA for DOS on and after January 1, 2024, if one of the following is true:

Members do not have other primary insurance on file with ForwardHealth and have had no claim activity for any memantine products for DOS in the last six months of 2023.
Members have other primary insurance on file with ForwardHealth and have had no claim activity for any memantine products for any DOS in 2023.

The remaining previously identified BadgerCare Plus, Medicaid, and SeniorCare members with active claim activity will be allowed to continue receiving memantine products without PA until further notice.

Topic #9837

Antibiotics, Inhaled

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Non-preferred drugs in the antibiotics, inhaled drug class require PA.

Tobi Podhaler and Cayston require clinical PA.

PA requests for non-preferred drugs in the antibiotics, inhaled drug class must be completed, signed, and dated by the prescriber. PA requests for non-preferred drugs in the antibiotics, inhaled drug class must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of non-preferred drugs in the antibiotics, inhaled drug class must be submitted with the PA request.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred drugs in the antibiotics, inhaled drug class may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

The following indicate how PA requests for non-preferred drugs in the antibiotics, inhaled drug class will be approved when clinical criteria have been met:

PA requests will be approved for up to a maximum 28-day supply per dispensing.
PA requests will be approved with an alternating 28-day treatment schedule of 28 days of a non-preferred drug in the antibiotics, inhaled drug class with 28 days of no inhaled antibiotics/anti-infective agents.

Note: The alternating 28-day treatment schedule with 28 days of no inhaled antibiotics/anti-infective agents above does not apply to approved PA requests for Cayston for CAT treatment. When PA is approved for Cayston for CAT, members may alternate between two inhaled antibiotics/anti-infective agents.

Clinical Criteria for Tobi Podhaler

Clinical criteria that must be documented for approval of a PA request for Tobi Podhaler are all of the following:

The member has cystic fibrosis.
The prescriber has confirmed that the member has a positive sputum culture for Pseudomonas aeruginosa. Prescribers are required to include a copy of the sputum culture report with all PA requests.
The prescriber has confirmed that the member is not colonized with Burkholderia cepacia.
The member is not receiving treatment with other inhaled antibiotics/anti-infective agents, including alternating treatment schedules. Prescribers are required to provide a history of all inhaled antibiotics/anti-infective agents within the most recent 90-day period.
The prescriber has submitted detailed clinical justification for prescribing Tobi Podhaler instead of Bethkis, Kitabis Pak, or tobramycin solution (generic Tobi), including clinical information describing why the member cannot use Bethkis, Kitabis Pak, or tobramycin solution (generic Tobi), and why it is medically necessary that the member receive Tobi Podhaler instead of Bethkis, Kitabis Pak, or tobramycin solution (generic Tobi).
The member has been adherent with their prescribed treatment regimen for inhaled medications.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Tobi Podhaler. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

Initial and renewal PA requests for Tobi Podhaler may be approved for up to 168 days.

Renewal PA requests for Tobi Podhaler require that the member be adherent with their inhaled antibiotic treatment.

Clinical Criteria for Cayston

Clinical criteria that must be documented for approval of a PA request for Cayston are all of the following:

The member has cystic fibrosis.
The prescriber has confirmed that the member has a positive sputum culture for Pseudomonas aeruginosa. Prescribers are required to include a copy of the sputum culture report with all PA requests.
The prescriber has confirmed that the member is not colonized with Burkholderia cepacia.
The member is not receiving treatment with other inhaled antibiotics/anti-infective agents, including alternating treatment schedules. Prescribers are required to provide a history of all inhaled antibiotics/anti-infective agents within the most recent 90-day period.
At least one of the following is true:
- The member has previously used inhaled tobramycin and experienced a clinically significant adverse drug reaction or an unsatisfactory therapeutic response.
- The member has a medical condition(s) that prevents the use of inhaled tobramycin.
The member has been adherent with their prescribed treatment regimen for inhaled medications.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Cayston. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

Initial and renewal PA requests for Cayston may be approved for up to 168 days.

Renewal PA requests for Cayston require that the member be adherent with their prescribed Cayston treatment regimen.

Clinical Criteria for Cayston for Continuous Alternating Therapy

Clinical criteria that must be documented for approval of a PA request for Cayston for CAT are all of the following:

The member has cystic fibrosis.
The prescriber has confirmed that the member has a positive sputum culture for Pseudomonas aeruginosa. Prescribers are required to include a copy of the sputum culture report with all PA requests.
The prescriber has confirmed that the member is not colonized with Burkholderia cepacia.
The member is experiencing persistent exacerbations or FEV1 decline with no significant improvement while using a single inhaled antibiotic drug or significant worsening of other markers that are being regularly tracked to monitor pulmonary disease progression.
The prescriber has provided specific treatment goals for the member's CAT.
The prescriber has provided a history of all inhaled antibiotics/anti-infective agents within the most recent 90-day period.
The member has been adherent with their prescribed treatment regimen for inhaled medications.

Note: ForwardHealth will not consider CAT as an initial choice for inhaled antibiotic therapy.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Cayston for CAT. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

Initial and renewal PA requests for Cayston for CAT may be approved for up to 168 days.

Renewal PA requests for Cayston for CAT require that the member has been adherent with their CAT treatment. Prescribers are required to include documentation with renewal PA requests that clearly demonstrates the member has made progress toward their CAT treatment goals.

Topic #21237

Anticonvulsants

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Expedited Emergency Supply for Anticonvulsants

ForwardHealth strongly encourages pharmacy providers to utilize the expedited emergency supply process for anticonvulsant drugs when it is determined that the member should begin taking the medication immediately, but the PA request submission and adjudication process would delay dispensing the medication to the member. This may occur if the member receives a prescription for a covered anticonvulsant drug and the prescriber has not completed the necessary PA form or the PA request is still in process.

Expedited emergency supply requests for anticonvulsant drugs will be approved for up to a 14-day supply. Members will be limited to receiving two 14-day expedited emergency supply approvals of the same drug from one pharmacy provider within a six-month time period. A PA is not required to be in process when the first expedited emergency supply request is submitted.

If a second expedited emergency supply is necessary for a member, there must be a PA request for the drug submitted to ForwardHealth, and it must be in the process of being adjudicated. The second expedited emergency supply request may be approved if a PA request is in process for the same drug and strength and the PA is submitted by the pharmacy that submitted the first expedited emergency supply request.

If a PA request for the drug has been approved, the second expedited emergency supply request will not be approved.

Requests for a second expedited emergency supply request may be submitted seven to 21 days after the initial request was submitted. Second expedited emergency supply requests will not be approved if they are submitted before day seven or after day 21.

For example, if an initial expedited emergency supply request was submitted on March 4 and a PA request for the drug was submitted on March 7 and a second expedited emergency supply is necessary for the member because the PA request had not yet been adjudicated, the second expedited emergency request may be submitted on March 10 or as late as March 24.

Vigadrone and Vigpoder

PA requests for Vigadrone and Vigpoder must be completed, signed, and dated by the prescriber. PA requests for Vigadrone and Vigpoder must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Vigadrone and Vigpoder may be submitted may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Vigadrone and Vigpoder

The clinical criteria that must be documented for approval of a PA request for Vigadrone or Vigpoder includes both of the following:

The prescriber has submitted detailed clinical justification for prescribing Vigadrone or Vigpoder instead of Sabril or vigabatrin (generic Sabril).
The clinical information must document why the member cannot use Sabril or vigabatrin (generic Sabril), including why it is medically necessary that the member receive Vigadrone or Vigpoder instead of Sabril or vigabatrin (generic Sabril).

Supporting clinical documentation and a copy of the member's current medical records must be submitted with the PA request to support the member's need for Vigadrone or Vigpoder. Initial PA requests for Vigadrone or Vigpoder may be approved for up to 183 days.

Renewal PA requests may be approved for up to 365 days. Medical records must be submitted demonstrating clinical improvement and must reflect member compliance with Vigadrone or Vigpoder.

Note: Vigadrone and Vigpoder are not available through expedited emergency supply.

Topic #8377

Antiemetics, Cannabinoids

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

PA is required for all antiemetic, cannabinoid drugs. PA requests for antiemetics, cannabinoids drugs must be completed, signed, and dated by the prescriber. PA requests for antiemetics, cannabinoids drugs must be submitted using the Prior Authorization Drug Attachment for Antiemetics, Cannabinoids form. Clinical documentation supporting the use of antiemetics, cannabinoids drugs must be submitted with the PA request.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Antiemetics, Cannabinoids form and a completed PA/RF to ForwardHealth.

PA requests for antiemetics, cannabinoids drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

A copy of the member's current medical records must be submitted with all PA requests for antiemetics, cannabinoids drugs. Medical records must document the member's medical work-up for the condition being treated including complete problem and medication lists.

If the clinical criteria for antiemetics, cannabinoids drugs are met, PA requests may be approved for up to 183 days.

Clinical Criteria for Dronabinol for Anorexia Associated With Weight Loss With AIDS

The clinical criteria for approval of a PA request for dronabinol for the treatment of anorexia associated with weight loss with AIDS for members who are not currently receiving dronabinol are all of the following:

The member has AIDS.
The member is experiencing anorexia associated with weight loss.
One of the following is true:
- The member's current BMI is 18.5 or greater, and the member had a 10 percent or greater decrease in weight from baseline in the past six months.
- The member's current BMI is less than 18.5.
The member's daily caloric intake has been optimized.

The clinical criteria for approval of a PA request for dronabinol for the treatment of anorexia associated with weight loss with AIDS for members who are currently receiving dronabinol are one of the following:

The member's current BMI is less than 18.5.
The member's current BMI is in the normal range (18.5–24.9) and has been stabilized in this range for less than six months.

Note: Members whose BMI has been stabilized in the normal range or above (18.5 or greater) for at least six months will not be granted a dronabinol PA renewal.

Clinical Criteria for Dronabinol for Chemotherapy-Related Nausea and Vomiting

The clinical criteria for approval of a PA request for dronabinol for the treatment of chemotherapy-related nausea and vomiting are all of the following:

The member is currently receiving chemotherapy.
The member is experiencing chemotherapy-related nausea and vomiting.
At least one of the following is true:
- The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with ondansetron or granisetron.
- The member is unable to take both ondansetron and granisetron due to one of the following:
  - There is a clinically significant drug interaction between another drug(s) the member is taking and both ondansetron and granisetron.
  - The member has a medical condition(s) that prevents the use of both ondansetron and granisetron.
The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with at least one of the following chemotherapy-related nausea and vomiting treatments: dexamethasone, haloperidol, lorazepam, metoclopramide, olanzapine, prochlorperazine, or promethazine.

Topic #18357

Antifungals, Topical

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Jublia and Tavaborole

PA requests for Jublia or tavaborole must be completed, signed, and dated by the prescriber. PA requests for Jublia or tavaborole must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Jublia or tavaborole may be submitted on the Portal, by fax, or by mail. PA requests for Jublia or tavaborole may not be submitted using the STAT-PA system.

Clinical Criteria for Jublia and Tavaborole

Clinical criteria that must be documented for approval of a PA request for Jublia or tavaborole are both of the following:

The member has onychomycosis of the toenails.
The member has been treated with ciclopirox topical solution for 48 weeks and experienced an unsatisfactory therapeutic response.

In addition to meeting both of the above clinical criteria, one of the following must be true:

The member has been treated with oral terbinafine and experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction.
There is a clinically significant drug interaction between another drug the member is taking and oral terbinafine.
The member has a medical condition(s) that prevents the use of oral terbinafine.

Prescribers should indicate the specific details about the unsatisfactory therapeutic response, clinically significant adverse drug reaction, clinically significant drug interaction or the medical condition(s) preventing the member from using oral terbinafine.

PA requests for Jublia or tavaborole may be approved for up 365 days.

Topic #18457

Antipsychotics

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Abilify MyCite

Abilify MyCite requires clinical PA.

PA requests for Abilify MyCite must be completed, signed, and dated by the prescriber. PA requests for Abilify MyCite must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form and the PA/RF.

PA requests for Abilify MyCite may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Abilify MyCite

Clinical criteria that must be documented for approval of a PA request for Abilify MyCite are all of the following:

The member has a mobile device with a data plan that is compatible with the MyCite monitoring application.
The member has attempted standard measures to improve medication adherence. The prescriber must identify what adherence measures the member has previously attempted.
The member has previously taken oral aripiprazole and had a measurable therapeutic response. The aripiprazole dose and approximate dates taken must be documented.
The prescriber has agreed to track and document the member's adherence with Abilify MyCite using the MyCite software program.

Clinical documentation and medical records must be submitted with the PA request to support the need for Abilify MyCite. PA requests for Abilify MyCite may be approved for up to 90 days.

PA for Antipsychotic Drugs for Children 8 Years of Age and Younger

All antipsychotic drugs prescribed for oral use for all children 8 years of age and younger require PA.

PA requests must meet the criteria for children 8 years of age and younger to allow coverage of an antipsychotic drug.

PA requests for antipsychotic drugs for children 8 years of age and younger must be submitted on the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form.

Claims submitted for an antipsychotic drug for children 8 years of age and younger without an approved Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form on file will be denied.

Prescribers are encouraged to write prescriptions for preferred antipsychotic drugs.

Background

ForwardHealth monitors the use of antipsychotic drugs in young children. The PA process is intended to scrutinize the prescribing of antipsychotic drugs for mood disorders and the monitoring of metabolic effects of this class of drugs. ForwardHealth strongly encourages prescribers to earnestly engage in clarifying the differentiation between DMDD and bipolar disorder, NOS.

The increased use of antipsychotic drugs in young children over the past decade has been associated with the frequent use of the diagnosis of bipolar disorder, NOS (F31.9) per the DSM-5 in many of these children. A discussion and review of the issues in differentiating bipolar disorder, NOS from DMDD can be found in the Journal of the American Academy of Child and Adolescent Psychiatry, Volume 52, Issue 5, May 5, 2013, pp. 466-481 (Towbin, K. MD, Axelson, D. MD, Leibenluft, E. MD, Birmaher, B. MD, "Differentiating Bipolar Disorder-Not Otherwise Specified and Severe Mood Dysregulation").

In recent years, there has been some progress in the research of these clinical issues. Specifically, the DSM-5 addresses the inclusion of DMDD (F34.8). This evolved out of the observation that many children with a diagnosis of bipolar disorder do not progress to having bipolar disorder, NOS as adults, thus bringing into question the use of antipsychotic drugs for these children. Many of the children with DMDD (or severe mood dysregulation as referenced in several research studies) respond to stimulants and/or SSRI antidepressants. Although SSRIs may cause mild activation when first administered, this is not necessarily mania. These antidepressants can be very effective for irritability associated with anxiety and depression in young children, and they have far fewer side effects than antipsychotic drugs. Clinicians need to be vigilant about target symptoms and strive to clarify persistent irritability as seen in DMDD versus the more classic episodic irritability typical of bipolar spectrum disorders. Clinicians who prescribe antipsychotic drugs to children with bipolar disorder, NOS diagnoses will need to become familiar with the details of the current research on differentiating DMDD from bipolar disorder, NOS.

Prescriber Responsibilities for Antipsychotic Drugs for Children 8 Years of Age and Younger

If a child is 8 years of age or younger and requires an oral antipsychotic drug, the prescriber is required to complete the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form. PA request forms must be faxed, mailed, or sent with the member to the pharmacy provider.

The pharmacy provider will use the completed form to submit a PA request to ForwardHealth. Prescribers should not submit the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form directly to ForwardHealth. Prescribers are required to retain a completed and signed copy of the PA form.

PA requests for covered antipsychotic drugs for children 8 years of age and younger are approved at the active ingredient level. Therefore, an approved PA request allows any covered NDC with the same active ingredient of the prior authorized drug to be covered with the same PA. For example, if a member has an approved PA request for risperidone 1 mg tablets and the prescriber orders a new prescription for risperidone 2 mg tablets, an amended PA request or new PA request is not required.

Clinical Documentation

If the PA request for antipsychotic drugs for children 8 years of age and younger is for a member who is being treated for autism or tics, the only documentation required is the diagnosis information described in the following list. Pharmacy providers are encouraged to submit all PA requests for autism and tics using the STAT-PA system. The following clinical documentation is required on PA requests for members who are being treated for a condition other than autism or tics and must be submitted on the Portal, by fax, or by mail:

Information about the child's diagnoses—There are appropriate indications for the use of antipsychotic drugs in young children with certain diagnoses, including autism spectrum disorders, psychotic disorders, and tic disorders. Antipsychotic drugs may also be helpful for severe symptoms of irritability, aggression, anger, or defiance that may accompany severe mood disorders, developmental disorders, or ADHD.
BMI measurements—Antipsychotic drugs can have profoundly adverse effects on weight, glucose, and lipids. Because of these well-documented side effects, the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form requires the submission of a BMI percentile measurement with each PA request. The BMI percentile measurement is required because it is the standard for stratifying individuals as obese or at-risk for obesity and, therefore, requiring closer monitoring and active intervention. Children who have a BMI percentile measurement greater than or equal to 85 percent are at risk for diabetes and the metabolic syndrome associated with many antipsychotic drugs. If the child's BMI percentile is 85 percent or greater, the PA request must include a triglyceride level and a fasting glucose or HBA1c drawn within the past six months for the PA request to be approved.

Target symptoms—The prescriber is required to be very familiar with the criteria for DMDD and to clarify persistent versus episodic irritability/anxiety/anger/temper outbursts as well as to identify the presence, or absence, of comorbid conditions.

Polypharmacy information—The Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form requires documentation of the child's experience with any psychoactive drugs, concurrent drugs, as well as previous drug trials in the preceding 12 months.

Specialty information—ForwardHealth is interested in tracking the prescriber's practice specialty information.

Documentation for non-preferred antipsychotic drug requests—If the prescriber is requesting a non-preferred antipsychotic drug, clinical documentation must be provided to support the request and must include detailed reasons why preferred drugs were discontinued or not utilized.

Pharmacy Responsibilities for Antipsychotic Drugs for Children 8 Years of Age and Younger

Pharmacy providers should ensure that they have received the completed Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form from the prescriber.

For BadgerCare Plus and Medicaid members, pharmacy providers should review the Preferred Drug List Quick Reference for the most current list of preferred and non-preferred drugs.

If a BadgerCare Plus or Medicaid member presents a prescription for a non-preferred antipsychotic drug, the pharmacy provider is encouraged to contact the prescriber to discuss preferred drug options. The prescriber may choose to change the prescription to a preferred antipsychotic drug if medically appropriate for the member.

It is important that pharmacy providers work with prescribers to ensure that members are given appropriate assistance regarding coverage information and the PA request submission process for antipsychotic drugs. Pharmacy providers are responsible for the submission of the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form to ForwardHealth. Pharmacy providers are required to retain a completed and signed copy of the PA form.

Brand name antipsychotic drugs prescribed to children 8 years of age and younger that are BMN require that a Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form be submitted on the Portal, by fax, or by mail with the PA/BMNA form and the PA/RF.

Two unique PA numbers will be assigned for a BMN antipsychotic drug. One PA number will be assigned to the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form, and the other will be assigned to the PA/BMNA form.

PA Request Submission Methods

Pharmacy providers are encouraged to use the STAT-PA system to submit PA requests for antipsychotic drugs for children who have one of the following conditions:

Autism
Tics

If the prescriber indicates on the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form that the child has autism or tics, no additional clinical information is required on the form, and the pharmacy may submit the request using the STAT-PA system.

PA requests cannot be submitted using the STAT-PA system if any of the following are true:

The child has a condition other than autism or tics.
The drug being requested is a non-preferred antipsychotic drug.
The child is 2 years of age or younger.
The PA request is for a BMN antipsychotic drug.

If the PA request is not approved through the STAT-PA system, pharmacy providers are required to submit the Prior Authorization Drug Attachment for Antipsychotic Drugs for Children 8 Years of Age and Younger form, a PA/RF, and any supporting documentation from the prescriber on the Portal, by fax, or by mail.

Approved PA Requests for Antipsychotic Drugs for Children 8 Years of Age and Younger

Neither a new PA request nor a PA amendment is needed if the antipsychotic drug the child is taking has changed and the new drug contains the same active ingredient as the original drug approved or if the child is taking multiple strengths of the same drug.

PA decision notice letters for antipsychotic drugs for children 8 years of age and younger will include a message stating: "The prior authorization for this drug has been approved at the active ingredient level instead of the drug strength and dosage form level. Additional PAs are not needed for a different strength of this same drug."

Expedited Emergency Supply for Antipsychotic Drugs for Children 8 Years of Age and Younger

ForwardHealth strongly encourages pharmacy providers to utilize the expedited emergency supply process for antipsychotic drugs for children 8 years of age and younger when it is determined that the member should begin taking the medication immediately, but the PA request submission and adjudication process would delay dispensing the medication to the member. This may occur if a child 8 years of age or younger receives a prescription for an antipsychotic covered drug and the prescriber has not completed the necessary PA form or the PA request is still in process.

Expedited emergency supply requests for antipsychotic drugs will be approved for up to a 14-day supply. Members will be limited to receiving two 14-day expedited emergency supply approvals of the same drug from one pharmacy provider within a six-month time period. A PA is not required to be in process when the first expedited emergency supply request is submitted.

If a PA request for the drug has been approved, the second expedited emergency supply request will not be approved.

Topic #22338

Bile Salts Drugs

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Bylvay, Cholbam, and Livmarli

PA requests for Bylvay, Cholbam, or Livmarli must be completed, signed, and dated by the prescriber. PA requests for Bylvay, Cholbam, or Livmarli must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Bylvay, Cholbam, or Livmarli may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Bylvay and Livmarli

The clinical criteria for approval of a PA request for Bylvay or Livmarli are all of the following:

The member's age must be consistent with FDA-approved product labeling for the drug requested.
One of the following is true:
- The member has pruritus associated with PFIC.
- The member has cholestatic pruritus associated with ALGS.

If the clinical criteria for Bylvay or Livmarli are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Bylvay and Livmarli may be approved for up to 365 days. Renewal PA requests must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in pruritus symptoms compared to the member's baseline prior to the initiation of the drug requested.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Cholbam

The clinical criteria for approval of a PA request for Cholbam are all of the following:

The member's age must be consistent with FDA-approved product labeling for Cholbam.
One of the following is true:
- The member has a bile acid synthesis disorder due to single enzyme defects.
- The member has a peroxisomal disorder (including Zellweger spectrum disorders) and exhibits manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption.

Supporting clinical information and a copy of the member's current medical records must be submitted with the PA request to support the member's condition and outline the member's current treatment plan. The member's baseline AST, ALT, GGT, alkaline phosphatase, bilirubin, and INR, prior to starting Cholbam, must be submitted with the initial PA request.

If the clinical criteria for Cholbam are met, initial PA requests may be approved for up to 90 days.

Renewal PA requests for Cholbam may be approved for up to 365 days. Renewal PA requests for Cholbam must include supporting clinical information and copies of the member's current medical records and lab work, including updated AST, ALT, GGT, alkaline phosphatase, bilirubin, and INR values, which demonstrate that the member's liver function has improved, compared to the member's baseline prior to the initiation of Cholbam.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Topic #23257

Bone Resorption Suppression Drugs

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Teriparatide (Generic Bonsity)

Teriparatide (generic Bonsity) requires clinical PA.

PA requests for teriparatide (generic Bonsity) must be completed, signed, and dated by the prescriber. PA requests for teriparatide (generic Bonsity) must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for teriparatide (generic Bonsity) may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Teriparatide (Generic Bonsity)

The clinical criteria that must be documented for approval of a PA request for teriparatide (generic Bonsity) includes both of the following:

The prescriber has submitted detailed clinical justification for prescribing teriparatide (generic Bonsity) instead of Forteo.
The clinical information must document why the member cannot use Forteo including why it is medically necessary that the member receive teriparatide (generic Bonsity) instead of Forteo.

Clinical documentation and medical records must be submitted with the PA request to support the need for teriparatide (generic Bonsity). PA requests for teriparatide (generic Bonsity) may be approved for up to 365 days.

Topic #22717

BPH Agents, Alpha Reductase Inhibitors

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Entadfi

Entadfi requires clinical PA.

PA requests for Entadfi must be completed, signed, and dated by the prescriber. PA requests for Entadfi must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Entadfi may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Entadfi

Clinical criteria that must be documented for approval of a PA request for Entadfi are all of the following:

The member has BPH with lower urinary tract symptoms.
The member has taken dutasteride and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The member has taken finasteride for at least two consecutive months and experienced a partial response.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Entadfi. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If the clinical criteria for Entadfi are met, PA requests may be approved for up to 182 days (26 weeks).

ForwardHealth allows only one Entadfi PA approval during a member's lifetime. Additional PA requests will not be approved.

Topic #16217

Cytokine and Cell Adhesion Molecule Antagonist Drugs

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Clinical PA is required for non-preferred cytokine and CAM antagonist drugs.

PA requests for non-preferred cytokine and CAM antagonist drugs will only be approved for use to treat the following identified clinical conditions:

Ankylosing spondylitis
Crohn's disease
ERA
DIRA
Giant cell arteritis
Hidradenitis suppurativa
JIA and systemic JIA
NMOSD
NOMID
nr-axSpA
PMR
Psoriasis
Psoriatic arthritis
RA
SSc-ILD
Ulcerative colitis
Uveitis

Otezla, a preferred drug in the cytokine and CAM antagonist drug class, is the only cytokine and CAM antagonist drug indicated for the clinical condition of oral ulcers associated with Behcet's disease. Preferred drugs do not require PA.

Biosimilar drug products to Humira are non-preferred drugs in the cytokine and CAM antagonists drug class.

Note: Adalimumab is the generic drug name for Humira, and each individual biosimilar for Humira is named with a specific four-letter designation placed after adalimumab. ForwardHealth uses a blanket "xxxx" placeholder after adalimumab (adalimumab-xxxx) when referring to the non-preferred Humira biosimilar drug products in the clinical PA criteria for the appropriate clinical condition. The Preferred Drug List Quick Reference pharmacy data table lists the brand names with the complete generic names of the non-preferred Humira biosimilar drug products in the cytokine and CAM antagonists drug class.

PA requests for cytokine and CAM antagonist drugs will only be approved for one cytokine and CAM antagonist drug per member. ForwardHealth does not cover treatment with more than one cytokine and CAM antagonist drug.

PA requests will not be considered for subcutaneous dosage forms of cytokine and CAM antagonist drugs that will be administered in a medical office or medical facility.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for non-preferred cytokine and CAM antagonist drugs. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

Initial PA requests for non-preferred cytokine and CAM antagonist drugs may be approved for up to 183 days.

Renewal PA requests for non-preferred cytokine and CAM antagonist drugs may be approved for up to 365 days. Renewal PA requests for non-preferred cytokine and CAM antagonist drugs must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in symptoms compared to their baseline prior to the initiation of the non-preferred cytokine and CAM antagonist drug.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Ankylosing Spondylitis

Enbrel, Humira, and Xeljanz are preferred drugs used to treat ankylosing spondylitis. Preferred drugs do not require PA.

Adalimumab-xxxx, Cimzia, Cosentyx subQ, Rinvoq, Simponi subQ, Taltz, and Xeljanz XR are non-preferred drugs used to treat ankylosing spondylitis.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat ankylosing spondylitis are all of the following:

The member has ankylosing spondylitis.
The prescription is written by a rheumatologist or through a rheumatology consultation.
The member has taken two preferred cytokine and CAM antagonist drugs for at least three consecutive months each and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred cytokine and CAM antagonist drug is being requested.

Adalimumab-xxxx

The prescriber must submit detailed clinical justification for prescribing adalimumab-xxxx instead of Humira. The clinical information must document why the member cannot use Humira, including why it is medically necessary that the member receive adalimumab-xxxx instead of Humira.

Xeljanz XR

The prescriber must submit detailed clinical justification for prescribing Xeljanz XR instead of Xeljanz. The clinical information must document why the member cannot use Xeljanz, including why it is medically necessary that the member receive Xeljanz XR instead of Xeljanz.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Ankylosing Spondylitis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat ankylosing spondylitis must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Ankylosing Spondylitis form.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Ankylosing Spondylitis form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat ankylosing spondylitis may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Crohn's Disease

Humira is a preferred drug used to treat Crohn's disease. Preferred drugs do not require PA.

Adalimumab-xxxx, Cimzia, Rinvoq, Skyrizi subQ, and Stelara subQ are non-preferred drugs used to treat Crohn's disease.

Note: Skyrizi and Stelara will require an IV induction prior to initiating treatment with the subQ. A PA request for the IV induction must be approved before ForwardHealth will consider PA for the subQ. PA for the IV induction may be obtained through the physician-administered drug PA process.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat Crohn's disease are all of the following:

The member has Crohn's disease.
The prescription is written by a gastroenterologist or through a gastroenterology consultation.
The member has taken one preferred cytokine and CAM antagonist drug for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred cytokine and CAM antagonist drug is being requested.

Adalimumab-xxxx

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Crohn's Disease

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat Crohn's disease must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Crohn's Disease and Ulcerative Colitis form.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Crohn's Disease and Ulcerative Colitis form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat Crohn's disease may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Deficiency of Interleukin-1 Receptor Antagonist

Kineret is a non-preferred drug used to treat DIRA.

Clinical criteria for approval of a PA request for Kineret used to treat DIRA are both of the following:

The member has DIRA.
The prescription is written by or through consultation with a DIRA specialist (for example, an immunologist or a rheumatologist).

Clinical documentation and medical records must be submitted with the PA request to support the member's condition of DIRA and outline the member's current treatment plan for DIRA.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Deficiency of Interleukin-1 Receptor Antagonist

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat DIRA must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for DIRA, Giant Cell Arteritis, NOMID, and nr-axSpA form.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for DIRA, Giant Cell Arteritis, NOMID, and nr-axSpA form and a completed PA/RF to ForwardHealth.

PA requests for Kineret used to treat DIRA may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Enthesitis-Related Arthritis

Cosentyx subQ is a non-preferred drug used to treat ERA.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat ERA are both of the following:

The member has ERA.
The prescription is written by a rheumatologist or through a rheumatology consultation.

Clinical documentation and medical records must be submitted with the PA request to support the member's condition of ERA and outline the member's current treatment plan for ERA.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Enthesitis-Related Arthritis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat ERA must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat ERA may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system.)

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Giant Cell Arteritis

Actemra subQ is a non-preferred drug used to treat giant cell arteritis.

Clinical criteria for approval of a PA request for Actemra subQ used to treat giant cell arteritis are both of the following:

The member has giant cell arteritis.
The prescription is written by a rheumatologist or through a rheumatology consultation.

Clinical documentation and medical records must be submitted with the PA request to support the member's condition of giant cell arteritis and outline the member's current treatment plan for giant cell arteritis.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Giant Cell Arteritis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat giant cell arteritis must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for DIRA, Giant Cell Arteritis, NOMID, and nr-axSpA form.

PA requests for Actemra subQ used to treat giant cell arteritis may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Hidradenitis Suppurativa

Humira is a preferred drug used to treat hidradenitis suppurativa. Preferred drugs do not require PA.

Adalimumab-xxxx and Cosentyx subQ are non-preferred drugs used to treat hidradenitis suppurativa.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat hidradenitis suppurativa are all of the following:

The member has hidradenitis suppurativa.
The prescription is written by a dermatologist or through a dermatology consultation.
The member has taken one preferred cytokine and CAM antagonist drug for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred cytokine and CAM antagonist drug is being requested.

Adalimumab-xxxx

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Hidradenitis Suppurativa

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat hidradenitis suppurativa must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Hidradenitis Suppurativa form.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Hidradenitis Suppurativa form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat hidradenitis suppurativa may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Neuromyelitis Optica Spectrum Disorder

Enspryng is a non-preferred drug used to treat NMOSD.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat NMOSD are all of the following:

The member has NMOSD.
The prescription is written by a neurologist or through a neurology consultation.
The member is anti-aquaporin-4 antibody positive.

Clinical documentation and medical records must be submitted with the PA request to support the member's clinical condition of NMOSD and outline the member's current treatment plan for NMOSD.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Neuromyelitis Optica Spectrum Disorder

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat NMOSD must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat NMOSD may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system.)

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Neonatal Onset Multisystem Inflammatory Disease

Kineret is a non-preferred drug used to treat NOMID.

Clinical criteria for approval of a PA request for Kineret used to treat NOMID are both of the following:

The member has NOMID.
The prescription is written by a rheumatologist or through a rheumatology consultation.

Clinical documentation and medical records must be submitted with the PA request to support the member's condition of NOMID and outline the member's current treatment plan for NOMID.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Neonatal Onset Multisystem Inflammatory Disease

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat NOMID must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for DIRA, Giant Cell Arteritis, NOMID, and nr-axSpA form.

PA requests for Kineret used to treat NOMID may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Non-Radiographic Axial Spondyloarthritis

Cimzia, Cosentyx subQ, Rinvoq, and Taltz are non-preferred drugs used to treat nr-axSpA.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat nr-axSpA are both of the following:

The member has nr-axSpA.
The prescription is written by a rheumatologist or through a rheumatology consultation.

Clinical documentation and medical records must be submitted with the PA request to support the member's condition of nr-axSpA and outline the member's current treatment plan for nr-axSpA.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Non-Radiographic Axial Spondyloarthritis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat nr-axSpA must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for DIRA, Giant Cell Arteritis, NOMID, and nr-axSpA form.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat nr-axSpA may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Polymyalgia Rheumatica

Kevzara is a non-preferred cytokine and CAM antagonist drug used to treat PMR.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat PMR are all of the following:

The member has PMR.
The prescription is written by or through consultation with a PMR specialist.
The member has taken corticosteroids and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.

Clinical documentation and medical records must be submitted with the PA request to support the member's condition of PMR and outline the member's current treatment plan for PMR.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Polymyalgia Rheumatica

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat PMR must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat PMR may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Psoriasis

Enbrel, Humira, and Otezla are preferred drugs used to treat psoriasis. Preferred drugs do not require PA.

Adalimumab-xxxx, Bimzelx, Cimzia, Cosentyx subQ, Siliq, Skyrizi subQ, Sotyktu, Stelara subQ, Taltz, and Tremfya are non-preferred drugs used to treat psoriasis.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat psoriasis are all of the following:

The member has psoriasis.
The prescription is written by a dermatologist or through a dermatology consultation.
The member has taken two preferred cytokine and CAM antagonist drugs for at least three consecutive months each and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred cytokine and CAM antagonist drug is being requested.

Adalimumab-xxxx

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Psoriasis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat psoriasis must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Psoriasis form.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Psoriasis form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat psoriasis may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Psoriatic Arthritis

Enbrel, Humira, Orencia subQ, Otezla, and Xeljanz are preferred drugs used to treat psoriatic arthritis. Preferred drugs do not require PA.

Adalimumab-xxxx, Cimzia, Cosentyx subQ, Rinvoq, Simponi subQ, Skyrizi subQ, Stelara subQ, Taltz, Tremfya, and Xeljanz XR are non-preferred drugs used to treat psoriatic arthritis.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat psoriatic arthritis are all of the following:

The member has psoriatic arthritis.
The prescription is written by a dermatologist or rheumatologist or through a dermatology or rheumatology consultation.
The member has taken two preferred cytokine and CAM antagonist drugs for at least three consecutive months each and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred cytokine and CAM antagonist drug is being requested.

Adalimumab-xxxx

Xeljanz XR

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Psoriatic Arthritis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat psoriatic arthritis must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for RA, JIA, and Psoriatic Arthritis form.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for RA, JIA, and Psoriatic Arthritis form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat psoriatic arthritis may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Rheumatoid Arthritis

Enbrel, Humira, Orencia subQ, and Xeljanz are preferred drugs used to treat RA. Preferred drugs do not require PA.

Actemra subQ, adalimumab-xxxx, Cimzia, Kevzara, Kineret, Olumiant, Rinvoq, Simponi subQ, and Xeljanz XR are non-preferred drugs used to treat RA.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat RA are all of the following:

The member has RA.
The prescription is written by a rheumatologist or through a rheumatology consultation.
The member has taken two preferred cytokine and CAM antagonist drugs for at least three consecutive months each and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction. Additionally, for PA requests for Simponi subQ solution, members must also continue to take methotrexate in combination with Simponi subQ solution.
The prescriber has indicated the clinical reason(s) why a non-preferred cytokine and CAM antagonist drug is being requested.

Adalimumab-xxxx

Xeljanz XR

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Rheumatoid Arthritis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat RA must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for RA, JIA, and Psoriatic Arthritis form.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat RA may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Juvenile Idiopathic Arthritis

Enbrel, Humira, Orencia subQ, and Xeljanz are preferred drugs used to treat JIA. Preferred drugs do not require PA.

Actemra subQ, adalimumab-xxxx, and Xeljanz Oral Solution are non-preferred drugs used to treat JIA.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat JIA are all of the following:

The member has JIA.
The prescription is written by a rheumatologist or through a rheumatology consultation.
The member has taken two preferred cytokine and CAM antagonist drugs for at least three consecutive months each and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred cytokine and CAM antagonist drug is being requested.

Adalimumab-xxxx

Xeljanz Oral Solution

The prescriber must submit detailed clinical justification for prescribing Xeljanz Oral Solution instead of Xeljanz. The clinical information must document why the member cannot use Xeljanz, including why it is medically necessary that the member receive Xeljanz Oral Solution instead of Xeljanz.

Clinical Criteria for Systemic Juvenile Idiopathic Arthritis

Actemra subQ is a non-preferred drug used to treat systemic JIA.

Clinical criteria for approval of a PA request for Actemra subQ used to treat systemic JIA are both of the following:

The member has systemic JIA.
The prescription is written by a rheumatologist or through a rheumatology consultation.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Juvenile Idiopathic Arthritis and Systemic Juvenile Idiopathic Arthritis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat JIA and systemic JIA must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for RA, JIA, and Psoriatic Arthritis form.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat JIA and systemic JIA may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Systemic Sclerosis-Associated Interstitial Lung Disease

Actemra subQ is a non-preferred drug used to treat SSc-ILD.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat SSc-ILD are both of the following:

The member has SSc-ILD.
The prescription is written by or through consultation with an SSc-ILD specialist.

Clinical documentation and medical records must be submitted with the PA request to support the member's condition of SSc-ILD and outline the member's current treatment plan for SSc-ILD.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Systemic Sclerosis-Associated Interstitial Lung Disease

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat SSc-ILD must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat SSc-ILD may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system.)

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Ulcerative Colitis

Humira and Xeljanz are preferred drugs used to treat ulcerative colitis. Preferred drugs do not require PA.

Adalimumab-xxxx, Entyvio subQ, Omvoh subQ, Rinvoq, Simponi subQ, Stelara subQ, and Xeljanz XR are non-preferred drugs used to treat ulcerative colitis.

Note: Stelara will require an IV induction prior to initiating treatment with the subQ. A PA request for the IV induction must be approved before ForwardHealth will consider PA for the subQ. PA for the IV induction may be obtained through the physician-administered drug PA process.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat ulcerative colitis are all of the following:

The member has ulcerative colitis.
The prescription is written by a gastroenterologist or through a gastroenterology consultation.
The member has taken two preferred cytokine and CAM antagonist drugs for at least three consecutive months each and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred cytokine and CAM antagonist drug is being requested.

Adalimumab-xxxx

Xeljanz XR

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Ulcerative Colitis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat ulcerative colitis must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Crohn's Disease and Ulcerative Colitis form.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat ulcerative colitis may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Uveitis

Humira is a preferred drug used to treat uveitis. Preferred drugs do not require PA.

Adalimumab-xxxx is a non-preferred drug used to treat uveitis.

Clinical criteria for approval of a PA request for non-preferred cytokine and CAM antagonist drugs used to treat uveitis are all of the following:

The member has uveitis.
The prescription is written by an ophthalmologist or through an ophthalmology consultation.
The member has taken one preferred cytokine and CAM antagonist drug for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred cytokine and CAM antagonist drug is being requested.

Adalimumab-xxxx

The prescriber is required to submit detailed clinical justification for prescribing adalimumab-xxxx instead of Humira. The clinical information must document why the member cannot use Humira, including why it is medically necessary that the member receive adalimumab-xxxx instead of Humira.

Submitting PA Requests for Cytokine and Cell Adhesion Molecule Antagonist Drugs for Uveitis

PA requests for non-preferred cytokine and CAM antagonist drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred cytokine and CAM antagonist drugs used to treat uveitis must be submitted using the Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Uveitis form.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Cytokine and CAM Antagonist Drugs for Uveitis form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred cytokine and CAM antagonist drugs used to treat uveitis may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Topic #23099

Erythropoiesis Stimulating Proteins

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Jesduvroq

Jesduvroq requires clinical PA.

PA requests for Jesduvroq must be completed, signed, and dated by the prescriber. PA requests for Jesduvroq must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Jesduvroq may be submitted may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Jesduvroq

The clinical criteria for approval of a PA request for Jesduvroq are all of the following:

The member has anemia due to chronic kidney disease.
The member has been receiving dialysis for at least the previous four months and will continue to receive dialysis during treatment with Jesduvroq.
The member does not have uncontrolled hypertension.
The member has taken two preferred erythropoiesis stimulating proteins and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why Jesduvroq is being requested.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Jesduvroq. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

Initial and Renewal PA Requests for Jesduvroq

If the clinical criteria for Jesduvroq are met, initial PA requests may be approved for up to 183 days. Renewal PA requests may be approved for up to 365 days.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Topic #9877

Fentanyl Mucosal Agents

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

PA requests for fentanyl mucosal agents must be submitted on the PA/PDL for Fentanyl Mucosal Agents. PA requests for fentanyl mucosal agents may be submitted using the STAT-PA system, on the ForwardHealth Portal, by fax, or by mail.

PA requests for fentanyl mucosal agents may be approved for up to a maximum of 183 days.

Clinical Criteria for Fentanyl Mucosal Agents

Clinical criteria for approval of a PA request for a fentanyl mucosal agent are all of the following:

The member has cancer that is causing persistent pain.
The member is tolerant to around-the-clock opioid therapy for his or her underlying, persistent cancer pain.
The member is currently taking a long-acting opioid analgesic drug(s).
The member has breakthrough cancer pain that is not relieved by other short-acting opioid analgesic drugs.

Topic #20617

Glucocorticoids, Oral

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Agamree and Emflaza

Clinical PA is required for Agamree and Emflaza.

PA requests for Agamree or Emflaza must be completed, signed, and dated by the prescriber. PA requests for Agamree or Emflaza must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Agamree or Emflaza may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Agamree and Emflaza

Clinical criteria that must be documented for approval of a PA request for Agamree or Emflaza are all of the following:

The member has a diagnosis of DMD.
The member's age must be consistent with FDA-approved product labeling for Agamree or Emflaza.
The prescription is written by or through consultation with a neurologist.
The member has experienced a clinically significant glucocorticoid adverse drug reaction with an adequate trial of prednisone that has required a dose reduction or discontinuation of prednisone.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Agamree or Emflaza. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Agamree or Emflaza are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Agamree or Emflaza may be approved for up to 365 days. Renewal PA requests for members who have DMD must include supporting clinical information and copies of the member's current medical records demonstrating that the member has experienced an improvement or resolution of the initial glucocorticoid adverse effects experienced with prednisone.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Topic #1988

Growth Hormone Drugs

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

All growth hormone prescriptions must be written by an endocrinologist or through an endocrinology consultation, except prescriptions written for Serostim or Zorbtive.

Note: ForwardHealth will consider the entire clinical record for the PA request determination decision.

Non-Preferred Growth Hormone Drugs

The following will not be considered as clinical criteria to support the need for a non-preferred growth hormone drug:

Nonadherence to previous growth hormone treatment
Member fear of needles
Member or prescriber preference for the use of a non-preferred growth hormone drug
Member or prescriber preference for a less frequent dosing schedule

PA requests for the following growth hormone drugs must be submitted on the PA/PDL for Growth Hormone Drugs form:

Serostim
Zorbtive
Growth hormone drugs for children and adolescents
Growth hormone drugs for adults

Pharmacy providers are required to submit the completed PA/PDL for Growth Hormone Drugs form and a completed PA/RF to ForwardHealth.

Clinical Criteria for Serostim

ForwardHealth covers Serostim for members with AIDS wasting disease or cachexia.

If clinical criteria for Serostim are met, initial PA requests for Serostim may be approved for up to 365 days. PA requests for Serostim must be submitted on the PA/PDL for Growth Hormone Drugs form and may be submitted to ForwardHealth using the STAT-PA system, on the Portal, by fax, or by mail.

Clinical Criteria for Zorbtive

ForwardHealth covers Zorbtive for members with short bowel syndrome with dependence on parenteral nutrition. Members are limited to a 28-day course of the drug to reduce dependence on parenteral nutrition.

PA requests for Zorbtive must be submitted on the PA/PDL for Growth Hormone Drugs form and may be submitted to ForwardHealth using the STAT-PA system, on the Portal, by fax, or by mail.

Clinical Criteria for Growth Hormone Drug Coverage for Children and Adolescents

ForwardHealth covers growth hormone drugs for children and adolescents when prescribed in a manner consistent with FDA-approved product labeling for the following indications:

The member has a history of panhypopituitarism involving at least two pituitary hormone deficiencies, not including growth hormone, and a history of hypothalamic-pituitary structural lesion(s).
The member has a history of cranial irradiation, tumor, or other structural midline lesion, in addition to a decreasing growth velocity and a low IGF-1 measurement below the age- and gender-specific lower limit of normal with normal thyroid function and adequate nutrition.
The member has growth failure or short stature associated with one of the following congenital conditions that have an FDA-approved indication for growth hormone use:
- Noonan syndrome
- Prader-Willi syndrome
- SHOX gene deficiency disorder
- Turner syndrome
The member has growth failure or short stature associated with chronic renal insufficiency in pre-kidney transplant members.
An SGA member is 2 years of age or older with a height that remains more than two standard deviations below the mean for chronological age and gender on a clinically appropriate growth chart. SGA is defined as infants with a birth weight below the 10th percentile for gestational age. Other causes for short stature must have been excluded, such as the following: growth inhibiting medication, chronic disease, other congenital conditions, thyroid disease, or under-nutrition. ForwardHealth will consider the entire clinical record for the PA request determination decision.
The member has growth failure or short stature for children and adolescents with growth hormone deficiency including all of the following:
- The member's height is more than two standard deviations below the mean for chronological age and gender on a clinically appropriate growth chart.
- Other causes for short stature must have been excluded, such as the following: growth inhibiting medication, chronic disease, other congenital conditions, thyroid disease, or under-nutrition. If IGF-1 levels are low, IGFBP-3 testing should be considered and under-nutrition should be evaluated and addressed before proceeding with growth hormone stimulation testing. If the results of the IGF-1/IGFBP-3 and bone age are normal, best clinical practice would indicate growth hormone stimulation testing is not necessary since growth hormone deficiency can effectively be excluded without the need for further testing due to recognized limitations of growth hormone stimulation testing and risk of false positive results.
- The member has failed to respond to at least two validated growth hormone stimulation tests performed using a well-standardized protocol, demonstrating a growth hormone peak response of less than 10 ng/mL after stimulation with a pharmacologic agent such as insulin, arginine, clonidine, or glucagon.

Growth Hormone Stimulation Testing Requirements for Children and Adolescents

Growth hormone stimulation testing should be conducted after an overnight fast, using a well-standardized protocol, and should be conducted for the appropriate duration of time specific to the agents used to ensure the peak growth hormone level is captured. Both stimulation tests can be administered on the same day. When growth hormone stimulation testing has been performed, complete testing results must be submitted with the PA request, including the following:

Confirmation that the member was fasting
The type of stimulation test and the dose of stimulating agent
A copy of the medical notes taken during the entire testing procedure, including vital signs and blood glucose levels
The time and results from each blood sample taken
The provider interpretation of the testing results

For members with thyroid deficiency, ForwardHealth only accepts results of the growth hormone stimulation tests that are performed after thyroid deficiency is adequately treated because growth hormone secretion may be subnormal merely as a result of hypothyroidism.

Growth hormone stimulation testing performed in a non-validated or sub-standard manner will not be considered by ForwardHealth to be an acceptable growth hormone stimulation test.

Growth hormone testing can provide useful information, but due to the recognized limitations of growth hormone stimulation testing and the risk of false positive results, ForwardHealth will consider the results of the growth hormone stimulation testing in the context of the entire clinical record for the PA request determination decision.

Documentation Requirements for PA Requests for Growth Hormone for Children and Adolescents

Detailed documentation of the medical work-up and testing used to determine the need for growth hormone treatment must be submitted with the PA request, including the following:

Detailed endocrinology and medical work-up, including medical problem list, current medication list, and medication history
Height and weight measurements over time plotted on the most clinically appropriate growth chart(s) for age and gender, including growth velocity, growth percentiles, and Z-scores
Copies of the most recent IGF-1 and IGFBP-3 lab reports
Bone age results
TSH level
Nutritional assessment
Any other relevant testing, such as advanced imaging of the hypothalamic-pituitary region, if performed

PA requests for growth hormone drugs for children and adolescents must be submitted on the PA/PDL for Growth Hormone Drugs form. PA requests for growth hormone drugs for children and adolescents may be submitted using the STAT-PA system when the member meets both of the following:

The member has growth failure or short stature associated with one of the following congenital conditions:

Noonan syndrome
Prader-Willi syndrome
SHOX gene deficiency disorder
Turner syndrome

The member is less than 14 years of age

All other PA requests for preferred or non-preferred growth hormone drugs may be submitted on the Portal, by fax, or by mail, but not using the STAT-PA system.

If clinical criteria for growth hormone drugs are met, initial PA requests may be approved for up to 183 days.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen. A copy of the current endocrinology clinic notes, including clinically appropriate height and weight growth charts for age and gender, the most current IGF-1 and/or IGFBP-3 lab testing results, growth velocity, and the most current bone age report, must be included with the PA request. Renewal PA requests may be approved for up to 365 days.

Conditions Not Covered for Growth Hormone Treatment for Children and Adolescents

ForwardHealth does not cover growth hormone treatment for the following conditions or circumstances:

Member has closed epiphyses.
Growth velocity is less than 2 cm/year while on growth hormone treatment, or growth velocity does not demonstrate a significant increase while on growth hormone treatment.
Mid-parental height is achieved using the following equation.

Mid-parental height = (father's height + mother's height) ÷ 2, + 2.5 inches (male) or - 2.5 inches (female)

Member is not compliant with prescribed growth hormone therapy.
Member has idiopathic short stature, which is a growth failure or short stature not associated with growth hormone deficiency or disease state.
Member is post kidney transplant.

Clinical Criteria for Growth Hormone Drug Coverage for Adults

ForwardHealth covers growth hormone drugs for adults when prescribed in a manner consistent with FDA-approved product labeling for the following indications:

The member has a history of panhypopituitarism during childhood involving at least two other pituitary hormone deficiencies, not including growth hormone, and treatment with a growth hormone drug during childhood.
The member has a history of hypopituitarism during childhood involving at least one other pituitary hormone deficiency, not including growth hormone, and treatment with a growth hormone drug during childhood. The diagnosis of growth hormone deficiency must be confirmed with an IGF-1 measurement below the age- and gender-specific lower limit of normal after stopping growth hormone for at least three months and at least one standard appropriate growth hormone stimulation test demonstrating a growth hormone peak response of less than the established adult reference values of the specific stimulation tests performed.
The member has a history of treatment with a growth hormone drug during childhood without evidence of other pituitary hormone deficiencies. The diagnosis of growth hormone deficiency must be confirmed with an IGF-1 measurement below the age- and gender-specific lower limit of normal after stopping growth hormone treatment for at least three months and at least two standard appropriate growth hormone stimulation tests demonstrating a growth hormone peak response of less than the established adult reference values of the specific stimulation tests performed.
The member has a history of a head injury, hypothalamic-pituitary structural lesion(s), or cranial irradiation and evidence of panhypopituitarism involving at least three other pituitary hormone deficiencies, not including growth hormone.
The member has a history of a head injury, hypothalamic-pituitary structural lesion(s), or cranial irradiation and evidence of hypopituitarism with at least one other pituitary hormone deficiency, not including growth hormone. Growth hormone deficiency must be confirmed with an IGF-1 measurement below the age- and gender-specific lower limit of normal and at least one standard appropriate growth hormone stimulation test demonstrating a growth hormone peak response of less than the established adult reference values of the specific stimulation tests performed.
The member has a history of a head injury, hypothalamic-pituitary structural lesion(s), or cranial irradiation without evidence of other pituitary hormone deficiencies. Growth hormone deficiency must be confirmed with an IGF-1 measurement below the age- and gender-specific lower limit of normal and at least two standard appropriate growth hormone stimulation tests demonstrating a growth hormone peak response of less than the established adult reference values of the specific stimulation tests performed.

Note: For individuals being treated for growth hormone deficiency due to trauma or subarachnoid hemorrhage, growth hormone deficiency must be reconfirmed at one year after the event for therapy to continue. If retesting does not confirm growth hormone deficiency, continued treatment will not be approved.

ForwardHealth does not cover growth hormone drugs for members who do not comply with their prescribed growth hormone therapy.

Growth Hormone Stimulation Testing Requirements for Adults

Growth hormone stimulation testing should not be considered in adults without suggestive history of growth hormone deficiency such as a history of growth hormone deficiency diagnosed in childhood, hypothalamic pituitary disease, or cranial irradiation. In cases where there is suggestive history of growth hormone deficiency and a serum IGF-1 concentration below the age- and gender-specific lower limit of normal, growth hormone stimulation testing may be considered.

Growth hormone stimulation testing should be conducted after an overnight fast, using a well-standardized protocol, and should be conducted for the appropriate duration of time specific to the agents used to ensure the peak growth hormone level is captured. When two growth hormone stimulation tests are required, both stimulation tests can be administered on the same day. When growth hormone stimulation testing has been performed, complete testing results must be submitted with the PA request, including the following:

Confirmation that the member was fasting
The type of stimulation test and the dose of the stimulating agent
A copy of the medical notes taken during the entire testing procedure, including vital signs and blood glucose levels
The time and results from each blood sample taken
The provider interpretation of the testing results

Growth hormone stimulation testing performed in a non-validated or sub-standard manner will not be considered by ForwardHealth to be an acceptable growth hormone stimulation test.

Growth hormone deficiency in an adult could be considered if the member has failed to respond to validated growth hormone stimulation testing performed using a well-standardized protocol, demonstrating a growth hormone peak response of less than the established level of the agent(s) given. Examples of agents commonly used in adult growth hormone stimulation testing include insulin, glucagon, and macimorelin. The peak response determining growth hormone deficiency for an adult differs based on the agent used, including the following:

Insulin tolerance test: A growth hormone peak response of less than 5 mcg/L at every time point during the hypoglycemic phase of the test (If adequate hypoglycemia is not achieved [<40 mg/dL], then growth hormone deficiency cannot be diagnosed.)
Glucagon test: A growth hormone peak response of less than 3 mcg/L at every time point during testing for members with a BMI less than 25 kg/m² or a growth hormone peak response of less than 1 mcg/L at every time point during testing in patients with a BMI greater than or equal to 25 kg/m²
Macimorelin-stimulation test: A growth hormone peak response of less than 2.8 ng/mlμg/L for members with a BMI of 40 kg/m² or less. Strong CYP3A4 inducers should be discontinued with sufficient washout time prior to testing with macimorelin. Strong CYP3A4 inducers may reduce the plasma macimorelin concentrations and may lead to false positive test results. (Note: The safety and diagnostic performance of macimorelin have not been established with a BMI greater than 40 kg/m².)

Note: Following the recommendation of the 2019 "American Association of Clinical Endocrinologists and American College of Endocrinology Guidelines for Management of Growth Hormone Deficiency in Adults and Patients Transitioning From Pediatric to Adult Care," ForwardHealth will not accept arginine stimulation testing for adults. The arginine stimulation tests have shown to exhibit a low sensitivity and specificity for adults and have not been systematically evaluated and validated.

Documentation Requirements for PA Requests for Growth Hormone for Adults

Detailed documentation of the medical work-up and testing used to determine the need for growth hormone treatment must be submitted with the PA request, including the following:

Detailed endocrinology and medical work-up, including medical problem list, current medication list, and medication history
Copies of the most recent IGF-1 lab reports
TSH level
Nutrition assessment
Any other relevant testing, such as advanced imaging of the hypothalamic-pituitary region, if performed

PA requests for growth hormone drugs for adults must be submitted on the PA/PDL for Growth Hormone Drugs form. PA requests for growth hormone drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

If clinical criteria for growth hormone drugs are met, initial PA requests may be approved for up to 183 days.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen. A copy of the current endocrinology clinic notes, including the most current IGF-1 lab testing results, must be included with the PA request. Renewal PA requests may be approved for up to 365 days.

Topic #23258

H. Pylori Drugs

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Voquenza

Voquenza requires clinical PA.

PA requests for Voquenza must be completed, signed, and dated by the prescriber. PA requests for Voquenza must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Voquenza may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Voquenza

The clinical criteria for approval of a PA request for Voquenza are all of the following:

The member's age must be consistent with FDA-approved product labeling for Voquenza.
One of the following is true:
- The member has erosive esophagitis.
- The member has healed erosive esophagitis.
The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with at least two proton pump inhibitors.

If the clinical criteria for Voquenza are met, PA requests may be approved for up to 56 days (20 mg) or 183 days (10 mg).

Topic #15517

H2 Antagonists

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Famotidine Suspension

PA is not required for famotidine suspension for BadgerCare Plus and Medicaid members who are 18 years of age or younger. For BadgerCare Plus, Medicaid, and SeniorCare members 19 years of age or older, PA is required for famotidine suspension.

Topic #21637

Headache Agents, Acute Treatment

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in the headache agents, acute treatment drug class.

Clinical PA is required for non-preferred headache agents, acute treatment drugs.

PA requests for non-preferred headache agents, acute treatment drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred headache agents, acute treatment drugs must be submitted on the Prior Authorization Drug Attachment for Headache Agents, Acute Treatment form. Clinical documentation supporting the use of the non-preferred headache agents, acute treatment drug must be submitted with the PA request.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Headache Agents, Acute Treatment form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred headache agents, acute treatment drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Note: Emgality 100 mg has separate PA submission requirements.

For information about general ForwardHealth PA policy for drugs that require PA approval, prescribers and pharmacy providers may refer to the Standard Pharmacy Policy for Covered and Noncovered Drugstopic. Providers may also refer to this topic for information about what may not be considered criteria to support the need for the drug.

Clinical Criteria for Non-Preferred Headache Agents, Acute Treatment Drugs

Clinical criteria for approval of a PA request for non-preferred headache agents, acute treatment drugs (excluding Emgality 100 mg) are all of the following:

The member's age is consistent with the FDA-approved product labeling for the drug requested.
The prescriber has evaluated and diagnosed the member as having a history of migraines, with or without aura, according to ICHD-3 diagnostic criteria.
One of the following is true:
- The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with at least two preferred drugs from the headache agents, triptans non-injectable drug class.
- The member has a clinically significant drug interaction with triptans and another medication the member is taking, or the member has a medical condition(s) that prevents the use of triptans.
The member has taken two preferred headache agents, acute treatment drugs and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for non-preferred headache agents, acute treatment drugs. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

The medical records must demonstrate that the member meets the clinical criteria and document the member's medical work-up for migraines including complete problem and medication lists.

If the clinical criteria for non-preferred headache agents, acute treatment drugs are met, PA requests may be approved for up to 365 days.

Submitting PA Requests for Emgality 100 mg

PA requests for Emgality 100 mg must be completed, signed, and dated by the prescriber. PA requests for Emgality 100 mg must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form and the PA/RF. Clinical documentation supporting the use of Emgality 100 mg must be submitted with the PA request.

PA requests for Emgality 100 mg may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Emgality 100 mg

Clinical criteria that must be documented for approval of an initial PA request for Emgality 100 mg are all of the following:

The member is 18 years of age or older.
The prescriber has evaluated and diagnosed the member as having episodic cluster headaches, according to the ICHD-3, diagnostic criteria.
The following information has been documented:
- The number or frequency of cluster headache attacks the member experiences during a cluster period
- The member's cluster period duration
- The member's pain-free, remission period duration
The prescriber is required to indicate the member's current episodic cluster headache medications (including drug name[s], dose, and dosing frequency).
The member must be compliant with the prescribed episodic cluster headache treatment regimen.
The member and prescriber have agreed to follow the established Emgality episodic cluster headache dosing recommendations (300 mg [administered as three consecutive injections of 100 mg each] at the onset of the cluster period, and then monthly until the end of the cluster period) as outlined in the FDA-approved patient labeling.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests (initial, initial renewal, and subsequent renewal) for Emgality 100 mg. The supporting clinical information and medical records must document:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

Medical records must document the member's medical work-up for episodic cluster headaches including complete problem and medication lists.

Starting a member on a medication by using manufacturer-provided samples or manufacturer patient assistance programs will not be considered as previous medication history for PA review.

If clinical criteria for Emgality 100 mg are met, initial PA requests may be approved for up to 183 days.

Initial Renewal PA Requests for Emgality 100 mg

Clinical criteria that must be documented for approval of initial renewal PA requests for Emgality 100 mg are all of the following:

The member's current frequency of cluster headache attacks during an episode has been documented.
The prescriber is required to indicate the member's current episodic cluster headache medications (including drug name[s], dose, and dosing frequency).
The member must be compliant with the prescribed episodic cluster headache treatment regimen.
The member experienced a clinically significant decrease in the frequency of cluster headache attacks during an episode compared to their baseline prior to initiation of treatment with Emgality 100 mg.
The member and prescriber will continue to follow the established Emgality episodic cluster headache dosing recommendations (300 mg [administered as three consecutive injections of 100 mg each] as the onset of the cluster period, and then monthly until the end of the cluster period) as outlined in the FDA-approved patient labeling.

Initial renewal PA requests for Emgality 100 mg may be approved for up to 183 days.

Subsequent Renewal PA Requests for Emgality 100 mg

Clinical criteria that must be documented for approval of subsequent renewal PA requests for Emgality 100 mg are all of the following:

The member's current frequency of cluster headache attacks during an episode has been documented.
The prescriber is required to indicate the member's current episodic cluster headache medications (including drug name[s], dose, and dosing frequency).
The member must be compliant with the prescribed episodic cluster headache treatment regimen.
The member has sustained a clinically significant decrease in the frequency of cluster headache attacks during an episode compared to their baseline prior to initiation of treatment with Emgality 100 mg.
The member and prescriber will continue to follow the established Emgality episodic cluster headache dosing recommendations (300 mg [administered as three consecutive injections of 100 mg each] at the onset of the cluster period, and then monthly until the end of the cluster period) as outlined in the FDA-approved patient labeling.

Subsequent renewal PA requests for Emgality 100 mg may be approved for up to 183 days.

Topic #21117

Headache Agents, Preventative Treatment

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Clinical PA is required for non-preferred headache agents, preventative treatment drugs.

Submitting PA Requests for Headache Agents, Preventative Treatment Drugs

PA requests for non-preferred headache agents, preventative treatment drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred headache agents, preventative treatment drugs must be submitted using the Prior Authorization Drug Attachment for Headache Agents, Preventative Treatment form. Clinical documentation supporting the use of non-preferred headache agents, preventative treatment drugs must be submitted with the PA request.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Headache Agents, Preventative Treatment form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred headache agents, preventative treatment drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Non-Preferred Headache Agents, Preventative Treatment Drugs

Clinical criteria for approval of an initial PA request for non-preferred headache agents, preventative treatment drugs are all of the following:

The member's age is consistent with the FDA-approved product labeling for the drug requested.
The prescriber has evaluated and diagnosed the member as having a history of migraines, with or without aura, according to ICHD-3 diagnostic criteria.
The member is compliant with the prescribed headache medication treatment regimen and continues to experience four or more migraine headache days per month.
The member's current prescribed migraine medication treatment regimen must be documented. The prescriber is required to indicate the member's current migraine preventative and rescue medications (drug name[s], dose, and dosing frequency) including Botox (if applicable).
The member has taken two preferred headache agents, preventative treatment drugs for at least three consecutive months each and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests (initial, initial renewal, and subsequent renewal) for non-preferred headache agents, preventative treatment drugs. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

The medical records must demonstrate that the member meets the clinical criteria and document the member's medical work-up for migraines, including the current number of headache days per month, the number of migraine days per month, and the average migraine duration (in hours), as well as complete problem and medication lists.

If clinical criteria for non-preferred headache agents, preventative treatment drugs are met, initial PA requests may be approved for up to 183 days.

Initial Renewal PA Requests for Non-Preferred Headache Agents, Preventative Treatment Drugs

Clinical criteria that must be documented for approval of initial renewal PA requests for non-preferred headache agents, preventative treatment drugs are all of the following:

The member experienced a clinically significant decrease in the number of migraine days per month and/or a decrease in migraine duration compared to their baseline prior to initiation of treatment with a non-preferred headache agents, preventative treatment drug.
The member's current prescribed migraine medication treatment regimen has been documented. The prescriber is required to indicate the member's current migraine preventative and rescue medications (drug name[s], dose, and dosing frequency) including Botox (if applicable).
The member has been compliant with their prescribed migraine medication treatment regimen.

Initial renewal PA requests for non-preferred headache agents, preventative treatment drugs may be approved for up to 365 days.

Subsequent Renewal PA Requests for Non-Preferred Headache Agents, Preventative Treatment Drugs

Clinical criteria that must be documented for approval of subsequent renewal PA requests for non-preferred headache agents, preventative treatment drugs are all of the following:

The member has sustained a clinically significant decrease in the number of migraine days per month and/or a decrease in migraine duration compared to their baseline prior to initiation of treatment with a non-preferred headache agents, preventative treatment drug.
The current number of headache days per month, the number of migraine days per month, and the average migraine duration (in hours) must be documented.
The member's current prescribed migraine headache medication treatment regimen has been documented. The prescriber is required to indicate the member's current migraine preventative and rescue medications (drug name[s], dose, and dosing frequency) including Botox (if applicable).
The member has been compliant with their prescribed migraine medication treatment regimen.

Subsequent renewal PA requests for non-preferred headache agents, preventative treatment drugs may be approved for up to 365 days.

Topic #9878

Headache Agents, Triptans Non-Injectable

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Non-preferred drugs in the headache agents, triptans non-injectable drug class require PA. Preferred drugs do not require PA.

PA requests for non-preferred headache agents, triptans non-injectable drugs must be submitted on the PA/PDL for Headache Agents, Triptans Non-Injectable form.

Pharmacy providers are required to submit the completed PA/PDL for Headache Agents, Triptans Non-Injectable form and a completed PA/RF to ForwardHealth.

PA requests for headache agents, triptans non-injectable drugs may be submitted using the STAT-PA system, on the Portal, by fax, or by mail.

Clinical Criterion for Non-Preferred Headache Agents, Triptans Non-Injectable Drugs

The sole clinical criterion for approval of a PA request for non-preferred headache agents, triptans non-injectable drugs is that the member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with at least three preferred drugs from the headache agents, triptans non-injectable drug class.

If the clinical criterion for non-preferred headache agents, triptans non-injectable drugs is met, PA requests may be approved for up to 365 days.

Topic #8858

Hypoglycemics, Glucagon-Like Peptide Agents

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

All drugs in the hypoglycemics, GLP-1 drug class are diagnosis restricted. A ForwardHealth-allowed diagnosis code must be indicated on claims (and PA requests when applicable) for all drugs in the hypoglycemics, GLP-1 drug class.

Both preferred and non-preferred hypoglycemics, GLP-1 agents require a ForwardHealth-allowed diagnosis code on claims submitted to ForwardHealth. All preferred hypoglycemics GLP-1 drug claims must be submitted with a ForwardHealth-allowed diagnosis code, or PA is required.

Prescribers are required to indicate a diagnosis on prescriptions for all drugs that are identified by ForwardHealth as diagnosis restricted. If a diagnosis is not indicated on the prescription, pharmacy providers should contact the prescriber to obtain the diagnosis and document the diagnosis on the prescription or pharmacy health care record. It is not acceptable for pharmacy providers to obtain the diagnosis from the member.

PA requests for non-preferred hypoglycemics, GLP-1 agents must be completed, signed, and dated by the prescriber. PA requests for non-preferred hypoglycemics, GLP-1 agents must be submitted using the Prior Authorization Drug Attachment for Hypoglycemics, GLP-1 Agents form.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Hypoglycemics, GLP-1 Agents form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred hypoglycemics, GLP-1 agents may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Non-Preferred Hypoglycemics, Glucagon-Like Peptide Agents

Clinical criteria for approval of a PA request for a non-preferred hypoglycemics, GLP-1 agent are all of the following:

The non-preferred drug is being prescribed in a manner consistent with the FDA-approved product labeling.
The member has type 2 diabetes mellitus.
The member's HbA1c was measured within the past six months.
If the member is not currently using a hypoglycemics, GLP-1 agent, their most recent HbA1c is 6.5 percent or greater.

One of the following must be documented for at least two of the preferred hypoglycemics, GLP-1 agents:

The member has taken the maximum dose of a preferred hypoglycemics, GLP-1 agent for at least three consecutive months and experienced an unsatisfactory therapeutic response in glycemic control.
The member experienced a clinically significant adverse drug reaction with a preferred hypoglycemics, GLP-1 agent.

The following will not be considered as criteria to support the need for a non-preferred hypoglycemics, GLP-1 agent:

Nonadherence to previous hypoglycemics, GLP-1 treatment
Member fear of needles
Member or prescriber preference for the use of an oral agent
Member or prescriber preference for the use of a non-preferred hypoglycemics, GLP-1 agent
Member or prescriber preference for a less frequent dosing schedule

PA requests for non-preferred hypoglycemics, GLP-1 agents may be initially approved for up to 183 days.

Renewal PA requests may be approved for up to 365 days if the member has been adherent with the prescribed treatment regimen and had a reduction in their HbA1c compared to their baseline prior to the initiation of the non-preferred hypoglycemics, GLP-1 agent.

Topic #22898

Hypoglycemics, Glucagon-Like Peptide Agents—Combinations

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Soliqua and Xultophy

Soliqua and Xultophy are non-preferred drugs in the hypoglycemics, GLP-1 agents—combinations drug class.

PA requests for Soliqua or Xultophy must be completed and signed by the prescriber. PA requests for Soliqua or Xultophy must be submitted using Section VI of the PA/DGA form and the PA/RF. Clinical documentation supporting the use of Soliqua or Xultophy must be submitted with the PA request.

PA requests for Soliqua or Xultophy may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Soliqua

Clinical criteria that must be documented for approval of a PA request for Soliqua are all of the following:

The non-preferred drug is being prescribed in a manner consistent with the FDA-approved product labeling.
The member has type 2 diabetes mellitus.
The member's target HbA1c treatment goal has been provided.
The member's current HbA1c (measured within the past three months) has been provided.
The member is not taking any meal-time insulin.
The member has used Lantus concurrently with Adlyxin for at least three consecutive months and reached their target HbA1c treatment goal. Both of the following dose requirements must be met:
- A Lantus dose must be less than or equal to 60 units taken once daily.
- An Adlyxin dose must be less than or equal to 20 mcg taken once daily.
PA requests for Soliqua will only be considered for once daily dosing. PA requests for twice daily dosing will be denied.

A copy of the member's diabetes management medical records must be provided to demonstrate the member meets the clinical criteria listed above.

If the clinical criteria for Soliqua are met, initial PA requests may be approved for up to 183 days.

Clinical Criteria for Xultophy

Clinical criteria that must be documented for approval of a PA request for Xultophy are all of the following:

The non-preferred drug is being prescribed in a manner consistent with the FDA-approved product labeling.
The member has type 2 diabetes mellitus.
The member's target HbA1c treatment goal has been provided.
The member's current HbA1c (measured within the past three months) has been provided.
The member is not taking any meal-time insulin.
The member has used Tresiba concurrently with Victoza for at least three consecutive months and reached their target HbA1c treatment goal. Both of the following dose requirements must be met:
- A Tresiba dose must be less than or equal to 50 units taken once daily.
- A Victoza dose must be less than or equal to 1.8 mg taken once daily.
PA requests for Xultophy will only be considered for once daily dosing. PA requests for twice daily dosing will be denied.

A copy of the member's diabetes management medical records must be provided to demonstrate the member meets the clinical criteria listed above.

If the clinical criteria for Xultophy are met, initial PA requests may be approved for up to 183 days.

Topic #19357

Hypoglycemics, Insulins Long-Acting

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

PA requests for non-preferred hypoglycemics, insulins long-acting drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred hypoglycemics, insulins long-acting drugs must be submitted using the Prior Authorization Drug Attachment for Hypoglycemics, Insulins Long-Acting form.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Hypoglycemics, Insulins Long-Acting form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred hypoglycemics, insulins long-acting drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Non-Preferred Hypoglycemics, Insulins Long-Acting Drugs

Clinical criteria that must be documented for approval of a PA request for a non-preferred hypoglycemics, insulins long-acting drug are all of the following:

The member has diabetes.
The member is unable to use Lantus due to one of the following:
- The member has used Lantus for at least six consecutive months and was unable to obtain adequate fasting glucose control.
- The member has used Lantus and experienced continued episodes of hypoglycemia.
The member is unable to use Levemir due to one of the following:
- The member has used Levemir at least six consecutive months and was unable to obtain adequate fasting glucose control.
- The member has used Levemir and experienced continued episodes of hypoglycemia.
The member's insulin treatment regimen was adjusted to optimize glycemic control or reduce hypoglycemia, and the member was compliant with their insulin treatment regimen and blood glucose monitoring schedule. (Insulin regimen adjustment options should include basal dose escalation, splitting the daily basal dose, adjusting the basal dosing time, and the addition or dose escalation of meal-time insulin.)

Note: Members who are using greater than or equal to 80 units per day of Lantus or Levemir are not required to attempt both products.

In addition to meeting the above clinical criteria, the following must be documented:

The member's current insulin treatment regimen
The member's previous insulin treatment regimen(s)
The member's proposed insulin treatment regimen to include the non-preferred hypoglycemics, insulins long-acting drug (initial PA request only)
The glycemic treatment goals the prescriber has established for the member, such as HbA1c and FBG

The following will not be considered as criteria to support the need for a non-preferred hypoglycemics, insulins long-acting drug:

Non-adherence to previous insulin treatment regimen
Member or prescriber preference for the use of a non-preferred hypoglycemics, insulins long-acting drug
Member or prescriber preference for a smaller injection volume

If clinical criteria for a non-preferred hypoglycemics, insulins long-acting drug are met, initial PA requests may be approved for up to 183 days. Medical records must be submitted to support the need for a non-preferred hypoglycemics, insulins long-acting drug.

Renewal PA requests may be approved for up to 365 days. A copy of the member's medical records must be submitted demonstrating an improvement in the member's glycemic control. Examples include a decrease in HbA1c, improved FBG, and decreased hypoglycemia.

Topic #18297

Hepatitis C Agents

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Preferred drugs in the hepatitis C agents drug class do not require PA.

PA requests for non-preferred hepatitis C agents must be completed, signed, and dated by the prescriber. PA requests for hepatitis C agents should be submitted using the Prior Authorization Drug Attachment for Hepatitis C Agents form.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescriber should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Hepatitis C Agents form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred hepatitis C agents may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Pharmacy Provider-Specific PA Requests for Hepatitis C Agents

PA requests for non-preferred hepatitis C agents are approved as pharmacy provider-specific. This approach is used to ensure continuity of care for members approved for treatment with these complex drug therapies. When a PA request is approved for drugs in this class, the pharmacy provider will be notified of the pharmacy provider-specific PA status via the decision notice letter. ForwardHealth recommends that the pharmacy provider inform the member of the pharmacy provider-specific PA requirement. The pharmacy provider should explain to the member that the drug therapy authorized must be dispensed by the pharmacy provider approved under the PA request.

Pharmacy providers should not submit PA requests for non-preferred hepatitis C agents if they do not intend to also dispense the entire drug therapy approved under the PA request to the member. If the member needs to discontinue receiving the drug from the approved pharmacy provider once the approved treatment has begun, the pharmacy provider is required to contact Provider Services. Provider Services will work with the pharmacy provider on the approved PA request to ensure the member does not experience a disruption of therapy, and if necessary, will facilitate the transfer of the PA to a new pharmacy provider.

Clinical Information That Must Be Documented on PA Requests for Hepatitis C Agents

A copy of the member's medical records that document the following must be submitted with the PA request:

HCV assessment and treatment plan
Current history and physical, including complete problem and medication list
Lab tests (performed within the last six months) for:
- Albumin
- CBC
- INR
- Liver function panel
- Serum creatinine
- HCV-RNA level
HCV genotype and subtype
HCV clinical data and medication treatment history, including the following:
- Likely source of the HCV infection and date diagnosed
- Liver biopsy, imaging studies, or blood assay tests to determine hepatic fibrosis
- History of previous hepatitis C drug therapy including medication name(s), dates taken, and treatment results (for example, null response, partial response, or relapse)
If the member has cirrhosis, documentation of the following clinical assessments:
- CTP class and score
- HCC status based on an imaging study performed within the last six months
- Presence or treatment of any of the following:
  - Ascites
  - Hepatic encephalopathy
  - Portal hypertension
  - HCC

If the required documentation is not submitted with the PA request, the PA request will be considered incomplete and will be returned to the provider, or it may be denied.

Clinical Criteria for Hepatitis C Agents

The requested non-preferred hepatitis C agent is being prescribed in a manner consistent with the FDA-approved product labeling.

Note: Only eight weeks of Harvoni treatment will be approved for treatment-naive members who have HCV genotype 1 infection without cirrhosis, have an HCV-RNA level less than 6 million IU/mL, and are HIV uninfected.

The clinical criteria for approval of a PA request for non-preferred hepatitis C drugs are all of the following:

The member is unable to take the preferred hepatitis C agent drugs due to one of the following:
- There is a clinically significant drug interaction with another drug the member is taking and the preferred drugs.
- The member has a medical condition(s) that prevents the use of the preferred drugs.
The member does not have a significant or uncontrolled concurrent disease that would significantly reduce their life expectancy or limit adherence (for example, cardiovascular disease, cancer, pulmonary disease).
For PA requests for Sovaldi, Vosevi, or Zepatier, the member does not have cirrhosis with moderate liver functional compromise (that is, CTP class B).
The member does not have cirrhosis with severe liver functional compromise (that is, CTP class C). Currently, there is no evidence to support that HCV treatment of members with end-stage liver disease impacts morbidity or mortality. The severity of liver damage present in decompensated liver disease makes it unlikely that treating the underlying infection would lead to meaningful liver function improvement. The only definitive treatment for end-stage liver disease is a liver transplant.

In addition to meeting all of the above clinical criteria and HCV treatment program requirements, Zepatier requests for members with HCV genotype 1a infection must be tested for the presence of NS5A resistance-associated polymorphisms.

For members who have received a liver transplant, ForwardHealth will consider the requested HCV treatment regimen based on the member's entire medical record. The level of clinical evidence for the requested HCV treatment regimen will be considered. If there is low clinical evidence of the treatment's effectiveness, the PA request will be denied.

For members who have received prior HCV treatment, ForwardHealth will consider the requested HCV treatment regimen based on the member's entire medical record in addition to the HCV treatment history and response (for example, null response, partial response, or relapse). The level of clinical evidence for the requested HCV treatment regimen will be considered. If there is low clinical evidence of the treatment's effectiveness, the PA request will be denied.

Topic #8857

Immunomodulators, Atopic Dermatitis

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Clinical PA is required for non-preferred systemic immunomodulator, atopic dermatitis drugs.

Cibinqo, Dupixent, and Rinvoq

PA requests for Cibinqo, Dupixent, or Rinvoq must be completed, signed, and dated by the prescriber. PA requests for Cibinqo, Dupixent, or Rinvoq for atopic dermatitis must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of Cibinqo, Dupixent, or Rinvoq must be submitted with the PA request.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Cibinqo, Dupixent, or Rinvoq may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

PA requests will not be considered for Dupixent that will be administered in a medical office or medical facility.

Clinical Criteria for Cibinqo, Dupixent, and Rinvoq for Members With Moderate to Severe Atopic Dermatitis

Clinical criteria that must be documented for approval of a PA request for Cibinqo, Dupixent, or Rinvoq for members with moderate to severe atopic dermatitis are all of the following:

The member's age is consistent with the FDA-approved product labeling for the drug requested.
The member has moderate to severe atopic dermatitis. Documentation must include the approximate BSA involved and the area(s) affected.
The prescription is written by or through consultation with a dermatologist, an allergist, or an immunologist.
Exacerbating factors that may contribute to the member's atopic dermatitis, such as member non-compliance with therapy, environmental factors, dietary factors, and other similar dermatologic conditions, have been ruled out.
The member will not use the requested drug in combination with any biologic immunomodulator.
At least one of the following is true:
- The member has a recent history (within a year of the clinical visit when the requested drug was first prescribed) of use of at least a medium-potency topical corticosteroid for at least two months and experienced an unsatisfactory therapeutic response.
- The member has used at least a medium-potency corticosteroid and experienced a clinically significant adverse drug reaction.
At least one of the following is true:
- The member is 6 months–11 years old (Dupixent PA requests).
- The member is 12 years of age or older and has taken Adbry for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction (Cibinqo, Dupixent, or Rinvoq PA requests).

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Cibinqo, Dupixent, or Rinvoq. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If the clinical criteria for Cibinqo, Dupixent, or Rinvoq are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Cibinqo, Dupixent, or Rinvoq may be approved for up to 365 days. Renewal PA requests for members who have moderate to severe atopic dermatitis must include supporting clinical information and copies of the member's current medical records demonstrating that the member has had a significant reduction in the area(s) affected and/or severity of atopic dermatitis.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Additional Conditions for Which PA Requests for Use of Dupixent Will Be Considered for Review

PA requests for Dupixent will only be approved for use to treat the following additional identified clinical conditions:

CRSwNP
EoE
Moderate to severe asthma with an eosinophilic phenotype
Oral corticosteroid dependent asthma
Prurigo nodularis

Clinical Criteria for Dupixent for Members With Chronic Rhinosinusitis With Nasal Polyposis

Clinical criteria that must be documented for approval of a PA request for Dupixent for members with CRSwNP are all of the following:

The member's age is consistent with the FDA-approved product labeling for Dupixent.
The member has CRSwNP.
The following documentation must be submitted:
- Size and location of nasal polyps
- Severity of nasal congestion
- Past nasal surgery history
- Plans for future nasal surgery
The prescription is written by or through consultation with an allergist or an ear, nose, and throat specialist.
The member has been adherent to and maintained on a maximized CRSwNP treatment regimen, including an INCS for at least three months prior to requesting Dupixent. Documentation should include the CRSwNP drug treatment names, doses, and start dates.
The member has taken Xolair for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The member will not use the requested drug in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Dupixent for members with CRSwNP. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Dupixent are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Dupixent may be approved for up to 365 days. Renewal PA requests for members who have CRSwNP must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in nasal polyp size or severity of congestion compared to the member's baseline prior to the initiation of Dupixent, and that the member has not had recent nasal polyp surgery. Members must also continue to take their maximized CRSwNP treatment regimen, including the INCS, during treatment with Dupixent.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Dupixent for Members With Eosinophilic Esophagitis

Clinical criteria that must be documented for approval of a PA request for Dupixent for members with EoE are all of the following:

The member's age and weight are consistent with the FDA-approved product labeling for Dupixent.
The member has EoE. A baseline intraepithelial eos/hpf, of greater than or equal to 15 must be documented.
The prescription is written by or through consultation with an allergist or a gastroenterologist.
Exacerbating factors that may contribute to the member's EoE, such as member non-compliance with therapy, environmental allergies, food allergies, acid reflux, and other allergic/immune conditions of the esophagus, have been ruled out.
At least one of the following is true:
- The member has a recent history (within a year of the clinical visit when the requested drug was first prescribed) of PPI use for at least two months and experienced an unsatisfactory therapeutic response.
- The member has used a PPI and experienced a clinically significant adverse drug reaction.
The member will not use the requested drug in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Dupixent for members with EoE. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Dupixent are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Dupixent may be approved for up to 365 days. Renewal PA requests for members who have EoE must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in eos/hpf or EoE symptoms (abdominal pain, chest pain, dysphagia, difficulty feeding, impaction, regurgitation, vomiting) compared to the member's baseline prior to the initiation of Dupixent.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Dupixent for Members With Moderate to Severe Asthma With an Eosinophilic Phenotype

Clinical criteria that must be documented for approval of a PA request for Dupixent for members with moderate to severe asthma with an eosinophilic phenotype are all of the following:

The member's age is consistent with the FDA-approved product labeling for Dupixent.
The member has moderate to severe asthma with an eosinophilic phenotype. A baseline blood eosinophil count of greater than 150 cells/mcL within the previous three months must be documented.
The prescription is written by or through consultation with an asthma specialist (for example, an allergist, an immunologist, or a pulmonologist).
At least one of the following is true:
- The member has a history of two or more asthma exacerbations that required treatment with systemic corticosteroids or an emergency department visit or hospitalization for the treatment of asthma in the past year. Documentation should include the approximate dates and what interventions took place for each exacerbation.
- The member's baseline FEV1 is less than 80 percent predicted. A baseline FEV1 percent predicted from the previous three months must be documented.
The member has been adherent to and maintained on a maximized asthma treatment regimen, including a high-dose ICS in combination with a LABA for at least three months prior to requesting Dupixent. Documentation should include the ICS and LABA names, doses, and start dates.
One of the following is true:
- The member is 6–11 years old.
- The member is 12 years of age or older and has taken Fasenra for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
Exacerbating factors that may contribute to the member's asthma, such as member non-compliance with therapy, environmental factors, dietary factors, and other similar respiratory conditions, have been ruled out.
The member will not use the requested drug in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Dupixent for members with moderate to severe asthma with an eosinophilic phenotype. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Dupixent are met, initial PA requests for Dupixent may be approved for up to 183 days.

Renewal PA requests for Dupixent may be approved for up to 365 days. Renewal PA requests for members who have moderate to severe asthma with an eosinophilic phenotype must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a decrease in the number of asthma exacerbations or an increase in FEV1 percent predicted compared to their baseline prior to initiation of Dupixent. Members must also continue to take their maximized asthma treatment regimen, including an ICS and a LABA, during treatment with Dupixent.

All renewal PA requests require the member to be adherent to the prescribed treatment regimen.

Clinical Criteria for Dupixent for Members With Oral Corticosteroid Dependent Asthma

Clinical criteria that must be documented for approval of a PA request for Dupixent for members with oral corticosteroid dependent asthma are all of the following:

The member's age is consistent with the FDA-approved product labeling for Dupixent.
The member has oral corticosteroid dependent asthma.
The prescription is written by or through consultation with an asthma specialist (for example, an allergist, an immunologist, or a pulmonologist).
The member has been adherent and maintained on a maximized asthma treatment regimen, including a high-dose ICS in combination with a LABA for at least three months prior to requesting Dupixent. Documentation should include the ICS and LABA names, doses, and start dates.
The member has required daily oral corticosteroid treatment for at least three months prior to requesting Dupixent. Documentation should include the oral corticosteroid name, daily dose, and start date.
Exacerbating factors that may contribute to the member's asthma, such as member non-compliance with therapy, environmental factors, dietary factors, and other similar respiratory conditions, have been ruled out.
The member will not use the requested drug in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Dupixent for members with oral corticosteroid dependent asthma. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Dupixent are met, initial PA requests for Dupixent may be approved for up to 183 days.

Renewal PA requests for Dupixent may be approved for up to 365 days. Renewal PA requests for members who have oral corticosteroid dependent asthma must include supporting clinical information and copies of the member's current medical records demonstrating that the member's daily oral corticosteroid dose has decreased, while maintaining asthma control compared to their baseline prior to initiation of Dupixent. Members must also continue to take their maximized asthma treatment regimen, including an ICS and a LABA, during treatment with Dupixent.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Dupixent for Members With Prurigo Nodularis

Clinical criteria that must be documented for approval of a PA request for Dupixent for members with prurigo nodularis are all of the following:

The member's age is consistent with the FDA-approved product labeling for Dupixent.
The member has moderate to severe prurigo nodularis.
The prescription is written by or through consultation with a dermatologist.
Exacerbating factors that may contribute to the member's prurigo nodularis, such as member non-compliance with therapy and other similar dermatologic conditions, have been ruled out.
At least one of the following is true:
- The member has a recent history (within a year of the clinical visit when the requested drug was first prescribed) of atopical treatment(s) to reduce itching and inflammation for at least two months and experienced an unsatisfactory therapeutic response.
- The member has used atopical treatment(s) to reduce itching and inflammation and experienced a clinically significant adverse drug reaction.
The member will not use the requested drug in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Dupixent for members with prurigo nodularis. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Dupixent are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Dupixent may be approved for up to 365 days. Renewal PA requests for members who have prurigo nodularis must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in prurigo nodularis symptoms compared to the member's baseline prior to the initiation of Dupixent.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Eucrisa and Opzelura for Atopic Dermatitis

PA requests for Eucrisa or Opzelura for atopic dermatitis must be completed, signed, and dated by the prescriber. PA requests for Eucrisa or Opzelura for atopic dermatitis must be submitted using the PA/PDL for Eucrisa and Opzelura for Atopic Dermatitis form. Clinical documentation supporting the use of Eucrisa must be submitted with the PA request.

Pharmacy providers are required to submit the completed PA/PDL for Eucrisa and Opzelura for Atopic Dermatitis form and a completed PA/RF to ForwardHealth.

PA requests for Eucrisa or Opzelura for atopic dermatitis may be submitted using the STAT-PA system, on the Portal, by fax, or by mail.

Clinical Criteria for Eucrisa and Opzelura for Atopic Dermatitis

Clinical criteria that must be documented for approval of a PA request for Eucrisa or Opzelura for atopic dermatitis are all of the following:

The member has atopic dermatitis.
At least one of the following is true:
- The member used a topical steroid for at least two consecutive months and experienced an unsatisfactory therapeutic response.
- The member used a topical steroid and experienced a clinically significant adverse drug reaction.
At least one of the following is true:
- The member used a topical calcineurin inhibitor for at least two consecutive months and experienced an unsatisfactory therapeutic response.
- The member used a topical calcineurin inhibitor and experienced a clinically significant adverse drug reaction.

If the clinical criteria for Eucrisa or Opzelura for atopic dermatitis are met, initial PA requests for Eucrisa or Opzelura may be approved for up to 365 days.

Additional Condition for Which PA Requests for Use of Opzelura Will Be Considered for Review

In addition to atopic dermatitis, PA requests for Opzelura will only be approved for use to treat vitiligo.

PA requests for Opzelura for members with vitiligo must be completed, signed, and dated by the prescriber. PA requests for Opzelura for members with vitiligo must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred Opzelura for members with vitiligo may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Opzelura for Members With Vitiligo

Clinical criteria that must be documented for approval of a PA request for Opzelura for members with vitiligo are all of the following:

The member's age is consistent with the FDA-approved product labeling for Opzelura.
The member has nonsegmental vitiligo. The member's total area BSA affected must be documented.
The BSA of the area to be treated must be 10 percent or less. The prescriber must document the specific areas to be treated.
The prescription is written by a dermatologist or through a dermatology consultation.
The member will not use Opzelura in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Opzelura for members with vitiligo. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Opzelura for members with vitiligo are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Opzelura for members with vitiligo may be approved for up to 365 days. Renewal PA requests for members who have vitiligo must include supporting clinical information and copies of the member's current medical records demonstrating that the member had meaningful repigmentation compared to the member's baseline prior to starting Opzelura.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Topic #22357

Immunomodulators, Asthma

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Clinical PA is required for non-preferred immunomodulator, asthma drugs.

Nucala and Tezspire

Nucala and Tezspire require clinical PA.

PA requests for Nucala or Tezspire must be completed, signed, and dated by the prescriber. PA requests for Nucala or Tezspire must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of Nucala or Tezspire must be submitted with the PA request.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Nucala or Tezspire may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Note: Fasenra, Nucala, Tezspire, and Xolair in the immunomodulators, asthma drug class are available as physician-administered drugs, as well as through the pharmacy benefit. The PDL and clinical PA criteria apply only to drugs billed through the pharmacy benefit.

Conditions for Which PA Requests for Use of Nucala Will Be Considered for Review

PA requests for Nucala will only be approved for use to treat the following identified clinical conditions:

Asthma with an eosinophilic phenotype
CRSwNP
EGPA
HES

Clinical Criteria for Nucala for Members With Asthma With an Eosinophilic Phenotype

Clinical criteria that must be documented for approval of a PA request for Nucala for members with asthma with an eosinophilic phenotype are all of the following:

The member has severe asthma with an eosinophilic phenotype. A baseline blood eosinophil count of greater than 150 cells/mcL within the previous three months must be documented.
The prescription is written by or through consultation with an asthma specialist (for example, an allergist, an immunologist, or a pulmonologist).
The member has been adherent to and maintained on a maximized asthma treatment regimen, including a high-dose ICS in combination with a LABA for at least three months prior to requesting Nucala. Documentation should include the ICS and LABA names, doses, and start dates.
One of the following is true:
- The member is 6–11 years old.
- The member is 12 years of age or older and has taken Fasenra for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The member will not use Nucala in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Nucala for members with asthma with an eosinophilic phenotype. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Nucala are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Nucala may be approved for up to 365 days. Renewal PA requests for members who have asthma with an eosinophilic phenotype must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in asthma symptoms compared to the member's baseline prior to the initiation of Nucala. Members must also continue to take their maximized asthma treatment regimen, including an ICS and a LABA, during treatment with Nucala.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Nucala for Members With Chronic Rhinosinusitis With Nasal Polyposis

Clinical criteria that must be documented for approval of a PA request for Nucala for members with CRSwNP are all of the following:

The member's age must be consistent with FDA-approved product labeling for Nucala.
The member has CRSwNP.
The prescription is written by or through consultation with an allergist or an ear, nose, and throat specialist.
The member has been adherent to and maintained on a maximized CRSwNP treatment regimen, including an INCS for at least three months prior to requesting Nucala. Documentation should include the CRSwNP drug treatment names, doses, and start dates.
The member has taken Xolair for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The member will not use Nucala in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Nucala for members with CRSwNP. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Nucala are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Nucala may be approved for up to 365 days. Renewal PA requests for members who have CRSwNP must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in CRSwNP symptoms compared to the member's baseline prior to the initiation of Nucala. Members must also continue to take their maximized CRSwNP treatment regimen, including the INCS, during treatment with Nucala.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Nucala for Members With Eosinophilic Granulomatosis With Polyangiitis

Clinical criteria that must be documented for approval of a PA request for Nucala for members with EGPA are all of the following:

The member's age must be consistent with FDA-approved product labeling for Nucala.
The member has EGPA.
The prescription is written by or through consultation with an EGPA specialist.
The member will not use Nucala in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with the PA request to support the member's condition of EGPA and outline the member's current treatment plan for EGPA.

If clinical criteria for Nucala are met, initial PA requests may be approved for up to 183 days. Renewal PA requests for Nucala may be approved for up to 365 days.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Nucala for Members With Hypereosinophilic Syndrome

Clinical criteria that must be documented for approval of a PA request for Nucala for members with HES are all of the following:

The member's age must be consistent with FDA-approved product labeling for Nucala.
The member has had HES for six or more months without an identifiable non-hematologic secondary cause.
The prescription is written by or through consultation with an HES specialist.
The member will not use Nucala in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with the PA request to support the member's condition of HES and outline the member's current treatment plan for HES.

If clinical criteria for Nucala are met, initial PA requests may be approved for up to 183 days. Renewal PA requests for Nucala may be approved for up to 365 days.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Tezspire

Clinical criteria that must be documented for approval of a PA request for Tezspire are all of the following:

The member has severe asthma.
The prescription is written by or through consultation with an asthma specialist (for example, an allergist, an immunologist, or a pulmonologist).
The member has a history of two or more asthma exacerbations that required treatment with systemic corticosteroids or an emergency department visit or hospitalization for the treatment of asthma in the past year. Documentation should include the approximate dates and what interventions took place for each exacerbation.
The member has been adherent to and maintained on a maximized asthma treatment regimen, including a high-dose ICS in combination with a LABA for at least three months prior to requesting Tezspire. Documentation should include the ICS and LABA names, doses, and start dates.
Exacerbating factors that may contribute to the member's asthma, such as member non-compliance with therapy, environmental factors, dietary factors, and other similar respiratory conditions, have been ruled out.
The member will not use Tezspire in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Tezspire. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Tezspire are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Tezspire may be approved for up to 365 days. Renewal PA requests for members who have severe asthma must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a decrease in the number of asthma exacerbations compared to the member's baseline prior to the initiation of Tezspire. Members must also continue to take their maximized asthma treatment regimen, including an ICS and a LABA, during treatment with Tezspire.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Topic #10660

Intranasal Rhinitis Agents

Mometasone furoate spray is a non-preferred drug in the intranasal rhinitis agents drug class. PA for mometasone furoate spray is not required for members 6 years of age or younger. Once a member reaches 7 years of age, PA is required.

Topic #12897

Legacy Exemptions for Alzheimer's Agents

BadgerCare Plus, Medicaid, and SeniorCare members who were eligible for the legacy exemption for galantamine tablets or galantamine ER for DOS on and after January 1, 2012, and remained eligible throughout 2023, will no longer be allowed to receive the legacy exemption for galantamine tablets or galantamine ER for DOS on and after January 1, 2024, if one of the following is true:

Members without other primary insurance on file with ForwardHealth who have had no claim activity for galantamine tablets or galantamine ER for DOS in the last six months of 2023
Members with other primary insurance on file with ForwardHealth who have had no claim activity for galantamine tablets or galantamine ER for DOS in calendar year 2023

PA is required for galantamine tablets and galantamine ER for members who do not have a legacy exemption for either one of the drugs.

Topic #10659

Legacy Exemptions for Antipsychotic Drugs

BadgerCare Plus, Medicaid, and SeniorCare members who were granted a legacy exemption for thioridazine for DOS on and after October 1, 2010, and remained eligible throughout 2023, will no longer be allowed to receive the legacy exemption for thioridazine for DOS on and after January 1, 2024, if one of the following is true:

Members without other primary insurance on file with ForwardHealth who have had no claim activity for thioridazine for DOS in the last six months of 2023
Members with other primary insurance on file with ForwardHealth who have had no claim activity for thioridazine for DOS in calendar year 2023

PA is required for thioridazine for BadgerCare Plus, Medicaid, and SeniorCare members who do not have a legacy exemption for the drug.

Topic #10661

Legacy Exemptions for Pancreatic Enzymes

Creon

Creon is a non-preferred drug. For BadgerCare Plus, Medicaid, and SeniorCare members previously granted a legacy exemption for Creon, their exemption will be expanded to all dosage strengths for Creon.

BadgerCare Plus, Medicaid, and SeniorCare members who were granted a legacy exemption for Creon for DOS on and after October 1, 2010, and remained eligible between July 1, 2022, and June 30, 2023, will no longer be allowed to receive any of the dosage strengths for Creon for DOS on and after July 1, 2023, if one of the following is true:

Members without other primary insurance on file with ForwardHealth who have had no claim activity for Creon for DOS in the first six months of 2023
Members with other primary insurance on file with ForwardHealth who have had no claim activity for Creon for DOS between July 1, 2022, and June 30, 2023

Topic #10662

Legacy Exemptions for Stimulant Drugs

BadgerCare Plus, Medicaid, and SeniorCare members who were granted a legacy exemption for designated amphetamine drugs for DOS on and after January 1, 2018, and remained eligible throughout 2023, will no longer be allowed to receive the legacy exemption for amphetamine drugs for DOS on and after January 1, 2024, if one of the following is true:

Members without other primary insurance on file with ForwardHealth who have had no claim activity for amphetamine drugs for DOS in the last six months of 2023
Members with other primary insurance on file with ForwardHealth who have had no claim activity for amphetamine drugs for DOS in calendar year 2023

Note: A member's legacy exemption for designated amphetamine drugs overrides the PDL PA policy only. Other policies continue to apply, such as member enrollment eligibility, diagnosis restriction, quantity limits, and noncovered service policies.

The table below lists the allowed legacy exemptions for amphetamine drugs and their applicable legacy exemption details.

Note: A legacy exemption is not applied to dextroamphetamine-amphetamine ER because the drug requires BBG PA. In addition to meeting established BBG criteria, PA requests for dextroamphetamine-amphetamine ER must also meet the clinical criteria for non-preferred stimulants.

Drugs in the stimulants drug class are diagnosis restricted. A ForwardHealth-allowed diagnosis code must be indicated on claims (and PA requests when applicable) for all stimulant drugs.

Designated Legacy Exemptions for Stimulant Drugs

Details

Dexedrine Spansule

dextroamphetamine

dextroamphetamine ER

Eligible members identified to be taking any one of these three drugs are allowed to receive any of the following as a legacy exemption stimulant drug:

Brand name Dexedrine Spansule
Generic dextroamphetamine
Generic dextroamphetamine ER

Note: An approved PA request is not required for any child 6 years of age or younger for generic dextroamphetamine.

Adderall

Adderall XR

dextroamphetamine-amphetamine

Eligible members identified to be taking any one of these three drugs are allowed to receive any of the following as a legacy exemption stimulant drug:

Adderall
Adderall XR
Generic dextroamphetamine-amphetamine

Note: For members allowed to receive brand name Adderall XR as a legacy exemption stimulant drug, ForwardHealth will automatically apply a generic copay to claims for brand name Adderall XR.

Note: An approved PA request is not required for any child 6 years of age or younger for brand name Adderall or generic dextroamphetamine-amphetamine.

Evekeo

Eligible members identified to be taking this drug are allowed to receive this drug only as a legacy exemption stimulant drug.

Note: An approved PA request is not required for any child 6 years of age or younger for Evekeo.

Topic #21617

Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitors

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

All drugs in the lipotropics, ACL inhibitor drug class are non-preferred and require PA.

PA requests for lipotropics, ACL inhibitor drugs must be completed and signed by the prescriber. PA requests for lipotropics, ACL inhibitor drugs should be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of a lipotropics, ACL inhibitor drug also must be submitted with the PA request.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. The prescriber should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for lipotropics, ACL inhibitor drugs may be submitted on the on the Portal, by fax, or by mail (but not using the STAT-PA system).

Conditions for Which PA Requests for Use of Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs Will Be Considered for Review

ForwardHealth will only consider PA requests for lipotropics, ACL inhibitor drugs to treat the following identified clinical conditions:

Clinical ASCVD
HeFH

Clinical Criteria for Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs for Members With Clinical Atherosclerotic Cardiovascular Disease

Clinical criteria that must be documented for approval of a PA request for lipotropics, ACL inhibitor drugs for members with clinical ASCVD are all of the following:

The member has clinical ASCVD, as evidenced by one of the following:
- The member has CAD, which is supported by a history of one of the following:
  - Myocardial infarction (heart attack)
  - Coronary revascularization
  - Angina pectoris
- The member has a history of non-hemorrhagic stroke.
- The member has symptomatic peripheral arterial disease as evidenced by one of the following:
  - Intermittent claudication with an ankle-brachial index of less than 0.85
  - Peripheral arterial revascularization procedure or amputation due to atherosclerotic disease
The member must have taken a statin regimen for at least three continuous months with failure to reach an LDL less than or equal to 70 mg/dL. The member must continue to take a statin during treatment with a lipotropics, ACL inhibitor drug.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for lipotropics, ACL inhibitor drugs. The supporting clinical information and medical records must document the following:

Evidence that the member has clinical ASCVD
A current lipid panel lab report
Documentation of the member's current and previous ACL inhibitor and statin drug therapies, including the following for each trial:
- Drug name(s) and dosage
- Dates taken
- Lipid panel report prior to and during drug therapy (including dates taken)

Initial and Renewal PA Requests for Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs for Members With Clinical Atherosclerotic Cardiovascular Disease

If the clinical criteria for lipotropics, ACL inhibitor drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for lipotropics, ACL inhibitor drugs may be approved for up to 365 days. Renewal PA requests for members who have clinical ASCVD must include supporting clinical information and copies of the member's current medical records demonstrating evidence of LDL reduction of at least 30 percent from pre-treatment baseline or a decrease to 100 mg/dL or less. Members also must continue to take a statin during treatment with the lipotropics, ACL inhibitor drug.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen. A copy of the current lipid panel report (within the past 30 days) must be included with the PA request.

Clinical Criteria for Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs for Members With Heterozygous Familial Hypercholesterolemia

Clinical criteria that must be documented for approval of a PA request for lipotropics, ACL inhibitor drugs for members with HeFH are all of the following:

The member has been diagnosed by a specialist in cardiology or lipid management.
The member has HeFH, as evidenced by clinical documentation that supports a definitive diagnosis of HeFH using either WHO criteria (Dutch Lipid Clinic Network clinical criteria with a score greater than eight) or Simon Broome diagnostic criteria.
The member must have taken a statin regimen for at least three continuous months with failure to reach an LDL less than or equal to 100 mg/dL. The member must continue to take a statin during treatment with a lipotropics, ACL inhibitor drug.

Evidence that the member has HeFH
A current lipid panel lab report
Documentation of the member's current and previous ACL inhibitor and statin drug therapies, including the following for each trial:
- Drug name(s) and dosage
- Dates taken
- Lipid panel report prior to and during drug therapy (including dates taken)

Initial and Renewal PA Requests for Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs for Members With Heterozygous Familial Hypercholesterolemia

If the clinical criteria for lipotropics, ACL inhibitor drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for lipotropics, ACL inhibitor drugs may be approved for up to 365 days. Renewal PA requests for members who have HeFH must include supporting clinical information and copies of the member's current medical records demonstrating evidence of LDL reduction of at least 30 percent from the pre-treatment baseline or a decrease to 130 mg/dL or less. Members also must continue to take a statin during treatment with a lipotropics, ACL inhibitor drug.

Topic #7817

Lipotropics, Omega-3 Acids

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

PA is required for non-preferred lipotropics, omega-3 acids.

PA requests for non-preferred lipotropics, omega-3 acids must be completed, signed, and dated by the prescriber. PA requests for non-preferred lipotropics, omega-3 acids must be submitted using the Prior Authorization Drug Attachment for Lipotropics, Omega-3 Acids form.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. The prescriber should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Lipotropics, Omega-3 Acids form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred lipotropics, omega-3 acids may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Conditions for Which PA Requests for Use of Non-Preferred Lipotropics, Omega-3 Acids Will Be Considered for Review

ForwardHealth will only consider PA requests for non-preferred lipotropics, omega-3 acids to treat the following identified clinical conditions:

Severe hypertriglyceridemia
ASCVD risk reduction

Clinical Criteria for Non-Preferred Lipotropics, Omega-3 Acids for Severe Hypertriglyceridemia

Clinical criteria for approval of a PA request for non-preferred lipotropics, omega-3 acids for severe hypertriglyceridemia are all of the following:

The member has a current or prior triglyceride level of 500mg/dL or greater.
The member has taken the maximum dose of a preferred lipotropic, omega-3 acid for at least three consecutive months and experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction.

A current lipid panel report completed within the past 30 days must be submitted with all PA requests.

If the clinical criteria for non-preferred lipotropics, omega-3 acids for severe hypertriglyceridemia are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests may be approved for up to 365 days if the member has been adherent with the prescribed treatment regimen and had a reduction in their triglyceride level compared to their baseline prior to the initiation of a non-preferred lipotropics, omega-3 acid.

Clinical Criteria for Non-Preferred Lipotropics, Omega-3 Acids for Atherosclerotic Cardiovascular Disease Risk Reduction

Clinical criteria for approval of a PA request for non-preferred lipotropics, omega-3 acids for ASCVD risk reduction are all of the following:

The member must have taken a maximized statin regimen for at least three consecutive months with failure to reach a triglyceride level of less than 150 mg/dL. The member must continue to take the maximized statin regimen along with the non-preferred lipotropic, omega-3 acid.
One of the following is true:
- The member has clinical ASCVD, as evidenced by one of the following:
  - The member has CAD, which is supported by a history of myocardial infarction (heart attack), coronary revascularization, or angina pectoris.
  - The member has a history of non-hemorrhagic stroke.
  - The member has symptomatic peripheral arterial disease as evidenced by intermittent claudication with an ABI of less than 0.85, peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.
- The member has diabetes mellitus and two or more of the following ASCVD risk factors:
  - Congestive heart failure
  - Current smoker
  - eGFR less than 60 mL/min/1.73 m²
  - Hypertension
  - Obesity

A current lipid panel report completed within the past 30 days must be submitted with all PA requests.

If the clinical criteria for non-preferred lipotropics, omega-3 acids for ASCVD risk reduction are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred lipotropics, omega-3 acids for ASCVD risk reduction may be approved for up to 365 days. Members must also continue to take the maximized statin treatment regimen during treatment with the non-preferred lipotropics, omega-3 acid.

Topic #19317

Lipotropics, Apo-B Inhibitors

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

PA is required for all lipotropics, apo-B inhibitor drugs.

PA requests for lipotropics, apo-B inhibitor drugs must be completed, signed, and dated by the prescriber. PA requests for lipotropics, apo-B inhibitor drugs must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of a lipotropics, apo-B inhibitor drug also must be submitted with the PA request.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for lipotropics, apo-B inhibitor drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Lipotropics, Apolipoprotein B Inhibitor Drugs

Clinical criteria that must be documented for approval of a PA request for lipotropics, apo-B inhibitor drugs are all of the following:

The member has HoFH, as evidenced by one of the following:
- The member has genetic confirmation of two of the following mutant alleles at the LDL receptor:
  - Apo-B
  - PCSK9
  - ARH adaptor protein gene locus
- The member has an untreated LDL-C greater than 500 mg/dL or a total treated LDL-C greater than or equal to 300 mg/dL and one of the following:
  - Cutaneous tendinous xanthoma(s) before 10 years of age
  - Untreated LDL-C levels of greater than or equal to 190 mg/dL in both parents
The member must have attempted to maximize treatment with LDL-lowering therapies prior to requesting a lipotropics, apo-B inhibitor drug. The member must have taken a PCSK9 inhibitor combined with a statin for at least three continuous months with failure to reach an LDL level of 130 mg/dL or less, or the member has had a clinically significant adverse drug reaction, clinically significant drug interaction, or medical condition preventing the member from using these drugs. Members also must continue to take the maximized LDL-lowering treatment regimen during treatment with the lipotropics, apo-B inhibitor drug.

Note: The member's inability to use one or more of the previously described drug therapies does not preclude the requirement for the member to use all of the above drug therapies for which the member does not have a clinically significant adverse drug reaction, clinically significant drug interaction, or medical condition preventing the member from using a specific drug.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for lipotropics, apo-B inhibitor drugs. The supporting clinical information and medical records must document the following:

Evidence that the member has HoFH
A current lipid panel lab report
Documentation of the member's current and previous PCSK9 inhibitor and statin drug therapies, including the following for each trial:
- Drug name(s) and dosage
- Dates taken
- Lipid panel report prior to and during drug therapy (including dates taken)
- Reasons for discontinuation if drug therapy was discontinued

If the clinical criteria for lipotropics, apo-B inhibitor drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for lipotropics, apo-B inhibitor drugs may be approved for up to 365 days. Renewal PA requests for members who have HoFH must include supporting clinical information and copies of the member's current medical records demonstrating evidence of LDL reduction of at least 30 percent from pre-treatment baseline or a decrease to 160 mg/dL or less. Members also must continue to take the maximized LDL-lowering treatment regimen during treatment with the lipotropics, apo-B inhibitor drug.

Topic #18737

Lipotropics, PCSK9 Inhibitors

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

PA is required for all lipotropics, PCSK9 inhibitors, including preferred lipotropics, PCSK9 inhibitors.

PA requests for lipotropics, PCSK9 inhibitors must be completed, signed, and dated by the prescriber. PA requests for lipotropics, PCSK9 inhibitors must be submitted using the Prior Authorization Drug Attachment for Lipotropics, PCSK9 Inhibitors form. Clinical documentation supporting the use of a lipotropics, PCSK9 inhibitor drug must be submitted with the PA request.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Lipotropics, PCSK9 Inhibitors form and a completed PA/RF to ForwardHealth.

PA requests for lipotropics, PCSK9 inhibitors may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Conditions for Which PA Requests for Use of Lipotropics, PCSK9 Inhibitor Drugs Will Be Considered for Review

ForwardHealth will only consider PA requests for PCSK9 inhibitor drugs to treat the following identified clinical conditions:

Clinical ASCVD
HeFH
HoFH

Clinical Criteria for Lipotropics, PCSK9 Inhibitor Drugs for Members With Clinical Atherosclerotic Cardiovascular Disease

Clinical criteria that must be documented for approval of a PA request for lipotropics, PCSK9 inhibitor drugs for members with clinical ASCVD are all of the following:

The member has clinical ASCVD, as evidenced by one of the following:
- The member has CAD, which is supported by a history of one of the following:
  - Myocardial infarction (heart attack)
  - Coronary revascularization
  - Angina pectoris
- The member has a history of non-hemorrhagic stroke.
- The member has symptomatic peripheral arterial disease as evidenced by one of the following:
  - Intermittent claudication with an ABI of less than 0.85
  - Peripheral arterial revascularization procedure or amputation due to atherosclerotic disease
The member attempted to maximize treatment with statins prior to requesting a lipotropics, PCSK9 inhibitor drug. The member must have taken a maximized statin regimen for at least three continuous months with failure to reach an LDL less than or equal to 70 mg/dL. Note: Members who are not taking a maximized statin regimen, which includes atorvastatin, rosuvastatin, or simvastatin, are required to attempt a second statin in order to establish a maximum treatment regimen.
The member must continue to take the maximized statin regimen during treatment with the lipotropics, PCSK9 inhibitor drug unless the member is statin intolerant. Statin intolerance must be established through trials with at least three different statins (with one regimen containing pravastatin, fluvastatin, or rosuvastatin).

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for lipotropics, PCSK9 inhibitor drugs. The supporting clinical information and medical records must document the following:

Evidence that the member has clinical ASCVD
A current lipid panel lab report
Documentation of the member's current and previous PCSK9 inhibitor and statin drug therapies, including the following for each trial:
- Drug name(s) and dosage
- Dates taken
- Lipid panel report prior to and during drug therapy (including dates taken)
- Reasons for discontinuation if drug therapy was discontinued

Note: For PA requests for non-preferred lipotropics, PCSK9 inhibitor drugs, the member must have taken a preferred lipotropics, PCSK9 inhibitor drug concurrently with a maximized statin regimen (if tolerant) for at least three continuous months with failure to reach an LDL less than or equal to 70 mg/dL.

If the clinical criteria for lipotropics, PCSK9 inhibitor drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for lipotropics, PCSK9 inhibitor drugs may be approved for up to 365 days. Renewal PA requests for members who have clinical ASCVD must include supporting clinical information and copies of the member?s current medical records demonstrating evidence of LDL reduction of at least 30 percent from pre-treatment baseline or a decrease to 100 mg/dL or less. Members also must continue to take the maximized statin treatment regimen (if tolerant) during treatment with the lipotropics, PCSK9 inhibitor drug.

Note: Members who have an approved PA request for Repatha will be allowed to remain on the drug as long as they continue to meet the renewal criteria.

Clinical Criteria for Lipotropics, PCSK9 Inhibitor Drugs for Members With Heterozygous Familial Hypercholesterolemia

Clinical criteria that must be documented for approval of a PA request for lipotropics, PCSK9 inhibitor drugs for members with HeFH are all of the following:

The member's age is consistent with the FDA-approved product labeling for the drug requested.
The member has been diagnosed by a specialist in cardiology or lipid management.
The member has HeFH, as evidenced by clinical documentation that supports a definitive diagnosis of HeFH using either WHO criteria (Dutch Lipid Clinic Network clinical criteria with a score greater than eight) or Simon Broome diagnostic criteria.
The member attempted to maximize treatment with statins prior to requesting a lipotropics, PCSK9 inhibitor drug. The member must have taken a maximized statin regimen for at least three continuous months with failure to reach an LDL less than or equal to 100 mg/dL. Note: Members who are not taking a maximized statin regimen, which includes atorvastatin, rosuvastatin, or simvastatin, are required to attempt a second statin in order to establish a maximum treatment regimen.
The member must continue to take the maximized statin regimen during treatment with the lipotropics, PCSK9 inhibitor drug unless the member is statin intolerant. Statin intolerance must be established through trials with at least three different statins (with one regimen containing pravastatin, fluvastatin, or rosuvastatin).

Evidence that the member has HeFH
A current lipid panel lab report
Documentation of the member's current and previous PCSK9 inhibitor and statin drug therapies, including the following for each trial:
- Drug name(s) and dosage
- Dates taken
- Lipid panel report prior to and during drug therapy (including dates taken)
- Reasons for discontinuation if drug therapy was discontinued

If the clinical criteria for lipotropics, PCSK9 inhibitor drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for lipotropics, PCSK9 inhibitor drugs may be approved for up to 365 days. Renewal PA requests for members who have HeFH must include supporting clinical information and copies of the member's current medical records demonstrating evidence of LDL reduction of at least 30 percent from pre-treatment baseline or a decrease to 130 mg/dL or less. Members also must continue to take the maximized statin treatment regimen (if tolerant) during treatment with the lipotropics, PCSK9 inhibitor drug.

Note: Members who have an approved PA request for Repatha will be allowed to remain on the drug as long as they continue to meet the renewal criteria.

Clinical Criteria for Lipotropics, PCSK9 Inhibitor Drugs for Members With Homozygous Familial Hypercholesterolemia

Clinical criteria that must be documented for approval of a PA request for lipotropics, PCSK9 inhibitor drugs for members with HoFH are all of the following:

The member's age is consistent with the FDA-approved product labeling for the drug requested.
One of the following is true:
- The member has genetic confirmation of two of the following mutant alleles at the LDL receptor:
  - Apo-B
  - PCSK9
  - Autosomal recessive hypercholesterolemia adaptor protein gene locus
- The member has an untreated LDL-C greater than 500 mg/dL or a total treated LDL-C greater than or equal to 300 mg/dL and one of the following:
  - Cutaneous tendinous xanthoma(s) before 10 years of age
  - Untreated LDL-C levels of greater than or equal to 190 mg/dL in both parents
The member must have attempted to maximize treatment with LDL-lowering therapies prior to requesting a lipotropics, PCSK9 inhibitor drug. The member must have received maximized LDL-lowering therapies for at least three continuous months with failure to reach an LDL level of 130 mg/dL or less.
The member must continue to take the maximized LDL-lowering therapies during treatment with the lipotropics, PCSK9 inhibitor drug.

Evidence that the member has HoFH
A current lipid panel lab report
Documentation of the member's current and previous LDL-lowering drug therapies, including the following for each trial:
- Drug name(s) and dosage
- Dates taken
- Lipid panel report prior to and during drug therapy (including dates taken)
- Reasons for discontinuation if drug therapy was discontinued

Note: For PA requests for non-preferred lipotropics, PCSK9 inhibitor drugs, the member must have taken a preferred lipotropics, PCSK9 inhibitor drug concurrently with maximized LDL-lowering therapies for at least three continuous months with failure to reach an LDL less than or equal to 130 mg/dL.

If the clinical criteria for lipotropics, PCSK9 inhibitor drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for lipotropics, PCSK9 inhibitor drugs may be approved for up to 365 days. Renewal PA requests for members who have HoFH must include supporting clinical information and copies of the member's current medical records demonstrating evidence of LDL reduction of at least 30 percent from pre-treatment baseline or a decrease to 160 mg/dL or less. Members also must continue to take the maximized LDL-lowering therapies during treatment with the lipotropics, PCSK9 inhibitor drug.

Note: Members who have an approved PA request for Repatha will be allowed to remain on the drug as long as they continue to meet the renewal criteria.

Topic #10997

Multiple Sclerosis Agents

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Clinical PA is required for non-preferred MS agents.

PA requests for non-preferred MS agents must be completed, signed, and dated by the prescriber. PA requests for non-preferred MS agents must be submitted on the Prior Authorization Drug Attachment for MS Agents form. Clinical documentation supporting the use of non-preferred MS agents must be submitted with the PA request.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for MS Agents form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred MS agents may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Non-Preferred Multiple Sclerosis Agents

Preferred MS agents do not require PA.

Clinical criteria for approval of an initial PA request for a non-preferred MS agent are all of the following:

The member has taken two preferred MS agents and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred MS agent is being requested.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for non-preferred MS agents. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

Initial and Renewal PA Requests for Non-Preferred MS Agents

If the clinical criteria for non-preferred MS agents are met, initial PA requests may be approved for up to 183 days. Renewal PA requests may be approved for up to 365 days.

Renewal PA requests for non-preferred MS agents must include copies of the member's current medical records demonstrating that the member's MS is stable and well-controlled without having disease-progressing symptoms.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Topic #22900

Multiple Sclerosis Agents, Interferons

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Non-preferred MS agents, interferons require PA.

PA requests for non-preferred MS agents, interferons must be completed, signed, and dated by the prescriber. PA requests for non-preferred MS agents, interferons must be submitted on the Prior Authorization Drug Attachment for MS Agents, Interferons form. Clinical documentation supporting the use of non-preferred MS agents, interferons must be submitted with the PA request.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for MS Agents, Interferons form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred MS agents, interferons may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Multiple Sclerosis Agents, Interferons

Clinical criteria for approval of an initial PA request for non-preferred MS agents, interferons are all of the following:

The member has taken two preferred MS agents, interferons and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The prescriber has indicated the clinical reason(s) why a non-preferred MS agents, interferon is being requested.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for non-preferred MS agents, interferons. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

Initial and Renewal PA Requests for Non-Preferred Multiple Sclerosis Agents, Interferons

If the clinical criteria for non-preferred MS agents, interferons are met, initial PA requests may be approved for up to 183 days. Renewal PA requests may be approved for up to 365 days.

Renewal PA requests for non-preferred MS agents, interferons must include copies of the member's current medical records demonstrating that the member's MS is stable and well-controlled without having disease-progressing symptoms.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Topic #22897

Multiple Scleroris Agents, Other

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Glatopa

PA requests for Glatopa must be completed, signed, and dated by the prescriber. PA requests for Glatopa must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Glatopa may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Glatopa

The prescriber must submit detailed clinical justification for prescribing Glatopa instead of the preferred MS agents Copaxone 20 mg and Copaxone 40 mg. This clinical information must document why the member cannot use Copaxone 20 mg and Copaxone 40 mg, including why it is medically necessary that the member receive Glatopa instead of Copaxone 20 mg and Copaxone 40 mg.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Glatopa. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

Initial and Renewal PA Requests for Glatopa

If the clinical criteria for Glatopa are met, initial PA requests may be approved for up to 183 days. Renewal PA requests may be approved for up to 365 days.

Renewal PA requests for Glatopa must include copies of the member's current medical records demonstrating that the member's MS is stable and well-controlled without having disease-progressing symptoms.

All renewal PA requests for Glatopa require the member to be adherent with the prescribed treatment regimen.

Topic #22218

Non-Preferred Drugs That Use the Prior Authorization/Preferred Drug List Exemption Request Form

PA requests for non-preferred drugs submitted with the PA/PDL Exemption Request form must be completed, signed, and dated by the prescriber. PA requests for non-preferred drugs designated to use the PA/PDL Exemption Request form must be submitted using the PA/PDL Exemption Request form.

Pharmacy providers are required to submit the completed PA/PDL Exemption Request form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred drugs submitted with the PA/PDL Exemption Request form may be submitted using the STAT-PA system, on the Portal, by fax, or by mail.

Clinical Criteria for Non-Preferred Drugs Submitted With the Prior Authorization/Preferred Drug List Exemption Request Form

Clinical criteria for approval of a PA request for a non-preferred drug submitted with the PA/PDL Exemption Request form are at least one of the following:

The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with at least one of the preferred drugs from the same PDL drug class as the drug being requested.
There is a clinically significant drug interaction between another drug the member is taking and at least one of the preferred drugs from the same PDL drug class as the drug being requested.
The member has a medical condition(s) that prevents the use of at least one of the preferred drugs from the same PDL drug class as the drug being requested.

Alternate Clinical Criteria for Non-Preferred Drugs in Eligible Drug Classes Only

The following drug classes have alternate clinical criteria that may be considered if the member does not meet the previously listed clinical criteria for non-preferred drugs submitted with the PA/PDL Exemption Request form:

Alzheimer's agents drug class
Anticonvulsants drug class
Antidepressants, other drug class
Antidepressants, SSRI drug class
Antiparkinson's agents drug class
Antipsychotics drug class
HIV/AIDS drug class
Pulmonary arterial hypertension drug class

Alternate clinical criteria may be considered if a member does not meet the previously listed clinical criteria for non-preferred drugs. Alternate clinical criteria are one of the following:

The member is new to ForwardHealth (the member has been granted eligibility for ForwardHealth within the past month) and has taken the requested non-preferred drug continuously for the last 30 days or longer with a measurable therapeutic response.
The member had an approved PA request for the non-preferred drug issued by ForwardHealth that recently expired, and the member has taken the requested non-preferred drug continuously for the last 30 days or longer and had a measurable therapeutic response.
The member was recently discharged from an inpatient stay in which the member was stabilized on the non-preferred drug being requested.

Topic #2328

Non-Steroidal Anti-Inflammatory Drugs

PA requests for non-preferred NSAIDs must be completed and signed by the prescriber and submitted using the PA/PDL for NSAIDs form.

PA requests for non-preferred NSAIDs may be submitted using the STAT-PA system, on the Portal, by fax, or by mail.

Clinical Criterion for NSAIDs

The clinical criterion for approval of a PA request for a non-preferred NSAID requires that the member has experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction with at least two preferred NSAIDs. (The two preferred NSAIDs cannot be ibuprofen or naproxen.)

If the clinical criterion for a non-preferred NSAID is met, PA requests may be approved for up to 365 days.

Topic #8917

Opioid Dependency Agents

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

The opioid dependency agents drug class contains the following subclasses:

Opioid dependency agents—buprenorphine
Opioid dependency agents—methadone
Opioid dependency agents—rescue agent
Opioid dependency and alcohol abuse/dependency agents

Opioid Dependency Agents—Buprenorphine

Drugs in the opioid dependency agents—buprenorphine drug class are diagnosis restricted.

PA requests for non-preferred drugs in the opioid dependency agents—buprenorphine drug class must be submitted on the PA/PDL for Opioid Dependency Agents—Buprenorphine form.

PA is not required for preferred drugs in the opioid dependency agents—buprenorphine drug class.

Note: The policy for obtaining physician-administered drugs applies to Sublocade.

Submitting PA Requests for Non-Preferred Opioid Dependency Agents—Buprenorphine

PA requests for non-preferred drugs in the opioid dependency agents—buprenorphine drug class must be completed, signed, and dated by the prescriber. PA requests for non-preferred drugs in the opioid dependency agents—buprenorphine drug class must be submitted on the PA/PDL for Opioid Dependency Agents—Buprenorphine form.

Pharmacy providers are required to submit the completed PA/PDL for Opioid Dependency Agents—Buprenorphine form and a completed PA/RF to ForwardHealth.

PA requests for buprenorphine tablets without naloxone for BadgerCare Plus, Medicaid, and SeniorCare members may be submitted using the STAT-PA system, on the Portal, by fax, or by mail.

PA requests for non-preferred buprenorphine-naloxone drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

PA requests for non-preferred buprenorphine-naloxone drugs may be approved for up to 365 days.

PA requests for buprenorphine tablets without naloxone for pregnant women only may be approved for the lesser of one of the following:

Up to 14 days past the member's expected due date entered on the PA/PDL for Opioid Dependency Agents—Buprenorphine form
Up to 300 days

Buprenorphine tablets without naloxone for pregnant women only are available through an expedited emergency supply request, which may be granted for up to a 14-day supply.

Clinical Criteria for Non-Preferred Opioid Dependency Agents—Buprenorphine

Clinical criteria for non-preferred opioid dependency agents—buprenorphine are all of the following:

The member has a diagnosis of opioid type dependence.
The member is 16 years of age or older.
The member is not taking other opioids, tramadol, or carisoprodol.

Clinical Criteria for Brixadi

Clinical criteria for approval of a PA request for Brixadi are both of the following:

The member meets the clinical criteria for non-preferred opioid dependency agents—buprenorphine.
The prescriber has submitted detailed clinical justification for prescribing Brixadi instead of Sublocade, including clinical information explaining why the member cannot use Sublocade and why it is medically necessary that the member receive Brixadi instead of Sublocade.

Clinical Criteria for Buprenorphine Tablets Without Naloxone

Buprenorphine tablets without naloxone are a non-preferred drug in the opioid dependency agents—buprenorphine drug class.

Clinical criteria for approval of a PA request for buprenorphine tablets without naloxone are both of the following:

The member meets the clinical criteria for opioid dependency agents—buprenorphine.
The member is pregnant, and the prescriber has indicated the member's expected delivery date.

Clinical Criteria for Non-Preferred Buprenorphine-Naloxone Drugs

Clinical criteria for approval of a PA request for non-preferred buprenorphine-naloxone drugs are both of the following:

The member meets the clinical criteria for opioid dependency agents—buprenorphine.
The prescriber has submitted detailed clinical justification for prescribing a non-preferred buprenorphine-naloxone drug instead of buprenorphine-naloxone tablets, Suboxone film, and Zubsolv, including clinical information explaining why the member cannot use buprenorphine-naloxone tablets, Suboxone film, and Zubsolv and why it is medically necessary that the member receive a non-preferred buprenorphine-naloxone drug instead of buprenorphine-naloxone tablets, Suboxone film, and Zubsolv.

Opioid Dependency Agents—Methadone

Methadone dispersible tablets and methadone oral concentrate are preferred drugs in the opioid dependency agents—methadone drug class; PA is not required.

Drugs in the opioid dependency agents—methadone drug class are diagnosis restricted.

Opioid Dependency Agents—Rescue Agent

Naloxone syringe, naloxone vial, and Narcan nasal spray are preferred drugs in the opioid dependency agents—rescue agent drug class; PA is not required.

Drugs in the opioid dependency agents—rescue agent drug class are not diagnosis restricted.

Opioid Dependency and Alcohol Abuse/Dependency Agents

Vivitrol injection and naltrexone tablets are preferred drugs in the opioid dependency and alcohol abuse/dependency agents drug class; PA is not required.

Drugs in the opioid dependency and alcohol abuse/dependency agents drug class are diagnosis restricted.

Note: The policy for obtaining physician-administered drugs applies to Vivitrol injection.

Topic #3509

Overview of Drug Legacy Exemptions

When applicable, ForwardHealth will designate either a generic or brand name drug with a legacy exemption for specific, affected BadgerCare Plus, Medicaid, or SeniorCare members. Affected BadgerCare Plus, Medicaid, or SeniorCare members are allowed to receive a legacy exemption for a drug as long as the drug remains non-preferred. A legacy exemption will not be applied to a drug that requires BBG or BMN PA. If BBG is applied to a generic drug with a legacy exemption, then the brand name drug will have the legacy exemption. If BMN is applied to a brand name drug with a legacy exemption, then the generic drug will have the legacy exemption.

When the generic equivalent for a drug with a legacy exemption becomes available, ForwardHealth will evaluate the relative cost of the generic and brand name drugs and determine whether the brand name or generic drug are designated with a legacy exemption. If the corresponding generic drug or brand name drug become preferred, the legacy exemption will be discontinued.

Members will no longer be allowed to receive a drug with a legacy exemption if one of the following is true:

Members without other primary insurance on file with ForwardHealth who have had no claim activity for the legacy exemption drug during the last six months
Members with other primary insurance on file with ForwardHealth who have had no claim activity for the legacy exemption drug during the last 12 months

When a pharmacy claim is submitted in real-time for a member who is not eligible to receive a drug with a legacy exemption, the pharmacy will receive an EOB code and an NCPDP reject code indicating a denial in the claim response informing the pharmacy that the drug requires PA.

Note: A member's legacy exemption for those designated drugs overrides the PDL PA policy only. Other policies continue to apply, such as member enrollment eligibility, diagnosis restriction, quantity limits, and noncovered service policies.

Topic #8877

Proton Pump Inhibitors

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Clinical PA is required for non-preferred PPI drugs.

PA requests for non-preferred PPI drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred PPI drugs must be submitted on the PA/PDL for PPI Capsules, Suspensions, and Non-Orally Disintegrating Tablets form or the PA/PDL for PPI Orally Disintegrating Tablets form.

Pharmacy providers must submit PA requests for all dosage forms of non-preferred PPI drugs except for orally disintegrating tablets on the PA/PDL for PPI Capsules, Suspensions, and Non-Orally Disintegrating Tablets form. For the other non-preferred PPI drugs (orally disintegrating tablets), pharmacy providers must submit PA requests on the PA/PDL for PPI for Orally Disintegrating Tablets form.

Pharmacy providers are required to submit the appropriately completed PA/PDL form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred PPI drugs may be submitted using the STAT-PA system, on the Portal, by fax, or by mail.

Clinical Criteria for Non-Preferred Proton Pump Inhibitor Capsules, Suspensions, and Non-Orally Disintegrating Tablets

The clinical criterion for approval of a PA request for a non-preferred PPI capsule, suspension, or non-orally disintegrating tablet is that the member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with at least two preferred PPI capsules, suspensions, or non-orally disintegrating tablets.

If the clinical criterion for non-preferred PPI capsules, suspensions, and non-orally disintegrating tablets is met, PA requests may be approved for up to 365 days.

Clinical Criteria for Non-Preferred Proton Pump Inhibitor Orally Disintegrating Tablets

Clinical criteria that must be documented for approval of a PA request for non-preferred PPI orally disintegrating tablets are all of the following:

The member has a medical condition(s) that prevents the use of PPI capsules and non-orally disintegrating tablets.
At least one of the following is true:
- The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with Nexium DR packet.
- There is a clinically significant drug interaction between another drug the member is taking and Nexium DR packet.
At least one of the following is true:
- The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with Protonix suspension.
- There is a clinically significant drug interaction between another drug the member is taking and Protonix suspension.

Note: Protonix suspension criteria do not apply to members under 5 years of age. Only Nexium DR packet criteria apply to members under 5 years of age.

If the clinical criteria for non-preferred PPI orally disintegrating tablets are met, PA requests may be approved for up to 365 days.

Topic #18817

Sedative Hypnotics

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

All orexin receptor antagonists in the sedative hypnotics drug class are non-preferred drugs that require PA.

PA requests for orexin receptor antagonists must be completed, signed, and dated by the prescriber. PA requests for orexin receptor antagonists must be submitted using the PA/PDL for Orexin Receptor Antagonists form.

Pharmacy providers are required to submit the completed PA/PDL for Orexin Receptor Antagonists form and a completed PA/RF to ForwardHealth.

PA requests for orexin receptor antagonists may be submitted using the STAT-PA system, on the Portal, by fax, or by mail.

Clinical Criteria for Orexin Receptor Antagonists

Clinical criteria for approval of a PA request for orexin receptor antagonists are all of the following:

The member's age is consistent with the FDA-approved product labeling for the drug requested.
The member does not have narcolepsy.
At least one of the following is true:
- The member has experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction with at least two preferred drugs from the sedative hypnotics drug class.
- The member has a medical history of substance abuse or misuse.

If the clinical criteria for orexin receptor antagonists are met, PA requests may be approved for up to 365 days.

Topic #16357

Stimulants

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Note: Some drugs in the stimulants drug class are designated as legacy stimulant drugs. For more information about designated legacy drugs in this drug class, providers may refer to the Legacy Exemptions for Stimulant Drugs topic.

Drugs in this class are diagnosis restricted. A ForwardHealth-allowed diagnosis code must be indicated on claims (and PA requests when applicable) for all stimulant drugs.

PA requests for non-preferred stimulants (except for methamphetamine) must be submitted on the PA/PDL for Non-Preferred Stimulants form.

Adderall, Dexedrine, dextroamphetamine-amphetamine, dextroamphetamine solution, dextroamphetamine tablets, Evekeo, and Zenzedi are non-preferred drugs; however, PA for Adderall, Dexedrine, dextroamphetamine-amphetamine; dextroamphetamine solution, dextroamphetamine tablets, Evekeo, or Zenzedi is not required for members who are 6 years of age or younger. Once a member reaches 7 years of age, PA will be required.

Clinical Criteria for Non-Preferred Stimulants

Clinical PA is required for non-preferred stimulants.

Clinical criteria for approval of a PA request for a non-preferred stimulant are both of the following:

At least one of the following is true:
- The member took Vyvanse for at least 60 consecutive days with a minimum of one dosage adjustment and experienced an unsatisfactory therapeutic response.
- The member took Vyvanse and experienced a clinically significant adverse drug reaction.
At least one of the following is true:
- The member took a methylphenidate stimulant for at least 60 consecutive days with a minimum of one dosage adjustment and experienced an unsatisfactory therapeutic response.
- The member took a methylphenidate stimulant and experienced a clinically significant adverse drug reaction.
- The member took a dexmethylphenidate stimulant for at least 60 consecutive days with a minimum of one dosage adjustment and experienced an unsatisfactory therapeutic response.
- The member took a dexmethylphenidate stimulant and experienced a clinically significant adverse drug reaction.

Submitting PA Requests for Non-Preferred Stimulants

PA requests for non-preferred stimulants (except for methamphetamine) must be completed and signed by the prescriber and must be submitted using the PA/PDL for Non-Preferred Stimulants form.

PA requests for non-preferred stimulants (except for dextroamphetamine-amphetamine ER or methamphetamine requests) may be submitted using the STAT-PA system, on the Portal, by fax, or by mail.

Methamphetamine

PA requests for methamphetamine should be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form and the PA/RF.

PA requests for methamphetamine may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Methamphetamine

Clinical criteria that must be documented for approval of a PA request for methamphetamine are all of the following:

The member is 6–17 years of age.
The member has had neuropsychological/psychological assessment that supports a diagnosis of ADHD.
The prescriber has provided documented and objective evidence (supplied by third-party, unrelated adult observers) of functioning deficits secondary to ADHD in at least two of the following domains of functioning:
- Home
- Work
- School
- Community
At least one of the following is true:
- The member took Vyvanse for at least 60 consecutive days with a minimum of one dosage adjustment and experienced an unsatisfactory therapeutic response.
- The member took Vyvanse and experienced a clinically significant adverse drug reaction.
At least one of the following is true:
- The member took a methylphenidate stimulant for at least 60 consecutive days with a minimum of one dosage adjustment and experienced an unsatisfactory therapeutic response.
- The member took a methylphenidate stimulant and experienced a clinically significant adverse drug reaction.
At least one of the following is true:
- The member took a dexmethylphenidate stimulant for at least 60 consecutive days with a minimum of one dosage adjustment and experienced an unsatisfactory therapeutic response.
- The member took a dexmethylphenidate stimulant and experienced a clinically significant adverse drug reaction.

PA requests must include medical records to support the above criteria have been met, including documentation of all past and current treatments that have been attempted (both pharmacologic and non-pharmacologic).

If clinical criteria for methamphetamine are met, PA requests will be approved for up to 183 days.

Stimulants and Stimulants, Related Agents – Wake Promoting Quantity Limits

Quantity limits apply to armodafinil, modafinil, Sunosi, and all preferred and non-preferred stimulants, with the exception of liquid dosage forms. Quantity limits do not apply to liquid dosage forms of stimulants. When a claim is submitted with a quantity that exceeds the limit, the claim will be denied.

The following applies to drugs in the stimulants drug class and the stimulants, related agents – wake promoting drug class:

Armodafinil, modafinil, Sunosi, and all preferred and non-preferred stimulants (with the exception of liquid dosage forms) have a cumulative quantity limit of 136 units per month for drugs in the stimulants drug class and the stimulants, related agents – wake promoting drug class.
Members are limited to a combined total of 136 units (tablets, capsules, or patches) per month, an exception being members with narcolepsy.
Members with narcolepsy are allowed a quantity limit override to receive up to 136 units of stimulants in addition to 250 mg of armodafinil or 400 mg of modafinil or 150 mg of Sunosi per day.
Azstarys and Xelstrym also have a drug-specific quantity limit of 34 units per month.

The Quantity Limit Drugs and Diabetic Supplies data table contains the most current quantity limits.

Overriding the Stimulants and Stimulants, Related Agents – Wake Promoting Quantity Limit Policy

Prior to requesting a quantity limit policy override, the pharmacy provider should contact the prescriber to determine whether or not it is medically appropriate for a member to exceed the quantity limit.

If it is medically appropriate for a member to exceed a quantity limit, pharmacy providers may request a quantity limit policy override by calling the DAPO Center.

Note: Providers are reminded that they may dispense up to the allowed quantity limit without contacting the DAPO Center.

Pharmacy providers may request a quantity limit policy override for members enrolled in BadgerCare Plus, Wisconsin Medicaid, or SeniorCare.

A quantity limit override request for drugs in the stimulants drug class and the stimulants, related agents – wake promoting drug class is limited to a one-month override and may be approved for the following situations:

Lost or stolen medication
Vacation supply
Medication and/or dosage change by the prescriber

In addition, pharmacy providers may request a quantity limit policy override for members with narcolepsy. Members with narcolepsy are allowed a quantity limit override to receive up to 136 units of stimulants in addition to 250 mg of armodafinil or 400 mg of modafinil or 150 mg of Sunosi per day.

If the member does not meet the policy for a stimulants quantity limit override through the DAPO Center, and the claim submitted exceeds the allowed stimulants quantity limit, the claim will be denied and the service will be a noncovered service. Members do not have appeal rights for noncovered services.

Topic #22339

Sickle Cell Anemia Drugs

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Oxbryta

For PA requests for Oxbryta, the prescriber is required to complete, sign, and date the PA/DGA form, using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the form.

The prescriber is required to send the completed PA/DGA form to the pharmacy where the prescription will be filled. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Oxbryta may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Oxbryta

Clinical criteria that must be documented for approval of a PA request for Oxbryta are all of the following:

The member has been diagnosed with SCD.
The member is 4 years of age or older.
The member will not use Oxbryta in combination with Adakveo or Endari.
The prescription is written by a hematologist or a provider who specializes in sickle cell disease.
The member has had one or more VOCs in the past 12 months. (VOC is defined as acute painful crisis or acute chest syndrome for which there was no explanation other than VOC.)
The member has a baseline hemoglobin level greater than or equal to 5.5 g/dL and less than or equal to 10 g/dL.
At least one of the following is true:
- The member has used hydroxyurea for at least three consecutive months and experienced an unsatisfactory therapeutic response.
- The member experienced a clinically significant adverse drug reaction with hydroxyurea.
- There is a clinically significant drug interaction between another drug(s) the member is taking and hydroxyurea.
- The member has a medical condition(s) that prevents the use of hydroxyurea.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Oxbryta. The supporting clinical information and medical records must document the following:

The information listed in the clinical criteria for PA approval
Details regarding previous medication use
The member's current treatment plan

If clinical criteria for Oxbryta are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Oxbryta may be approved for up to 365 days. Renewal PA requests for members who have SCD must include supporting clinical information and copies of the member's current medical records demonstrating that the member has experienced a response as evidenced by a measurable increase in hemoglobin level from baseline since starting Oxbryta treatment.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Topic #19878

Stimulants, Related Agents – Wake Promoting

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Armodafinil and modafinil are preferred drugs in the stimulants, related agents – wake promoting drug class; PA is not required. Sunosi is a non-preferred drug in the stimulants, related agents – wake promoting class and does require PA.

Clinical PA is required for non-preferred stimulants, related agents – wake promoting drugs.

Non-Preferred Stimulants, Related Agents – Wake Promoting

PA requests for non-preferred drugs in the stimulants, related agents – wake promoting class must be completed, signed, and dated by the prescriber. The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

PA requests for non-preferred drugs in the stimulants, related agents – wake promoting class must be submitted using the Prior Authorization Drug Attachment for Non-Preferred Stimulants, Related Agents—Wake Promoting form and the PA/RF.

PA requests for non-preferred drugs in the stimulants, related agents – wake promoting class may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Conditions for Which PA Requests for Non-Preferred Stimulants, Related Agents – Wake Promoting Drugs Will Be Considered for Review

PA requests for non-preferred drugs in the stimulants, related agents – wake promoting class will only be approved for use to treat the following identified clinical conditions:

EDS associated with narcolepsy
EDS associated with OSA

Clinical Criteria for Non-Preferred Stimulants, Related Agents – Wake Promoting Drugs for Members With Narcolepsy

Clinical criteria for approval of PA requests for non-preferred drugs in the stimulants, related agents – wake promoting class for members with narcolepsy are all of the following:

The member is 18 years of age or older.
The member has EDS associated with narcolepsy.
An overnight PSG sleep study and MSLT have been performed for the member using standard protocols, and the prescribing provider has submitted medical record documentation supporting a clinical correlation between the test results and a diagnosis of narcolepsy.
The overnight PSG test results and provider interpretation have been submitted with the PA request and include documentation of the following:
- The member's total sleep time was at least 360 minutes.
- The member experienced minimal sleep interruptions (for example, respiratory events or periodic leg movements).
- The provider interpretation indicates that an adequate night's sleep was achieved.
The MSLT results and provider interpretation have been submitted with the PA request and include documentation of the following:
- The MSLT was conducted the morning after the overnight PSG.
- The average sleep latency for all naps was eight minutes or less.
- The member achieved at least two SOREMPs. (A SOREMP within 15 minutes of sleep onset on the preceding nocturnal PSG may replace one of the SOREMPs on the MSLT.)
The member is not currently taking any other drugs in the stimulants, related agents – wake promoting class.
The member is not taking any sedative hypnotics.
For members currently taking CNS depressants (for example, anxiolytics, barbiturates, or opioids), the prescriber has evaluated the CNS depressants and determined they are not contributing to the member's EDS.
At least one of the following is true:
- The member has tried armodafinil and experienced an unsatisfactory therapeutic response after the medication had been titrated to a maximum recommended daily dose.
- The member experienced a clinically significant adverse drug reaction with armodafinil.
- The member has a medical condition that prevents treatment with armodafinil.
- There is a clinically significant drug interaction with another medication the member is taking and armodafinil.
At least one of the following is true:
- The member has tried modafinil and experienced an unsatisfactory therapeutic response after the medication had been titrated to a maximum recommended daily dose.
- The member experienced a clinically significant adverse drug reaction with modafinil.
- The member has a medical condition that prevents treatment with modafinil.
- There is a clinically significant drug interaction with another medication the member is taking and modafinil.

If initial clinical criteria for non-preferred drugs in the stimulants, related agents – wake promoting class for members with narcolepsy are met, PA requests may be approved for up to 183 days. Renewal PA requests for non-preferred drugs in the stimulants, related agents – wake promoting class may be approved for up to 365 days.

Clinical Criteria for Non-Preferred Stimulants, Related Agents – Wake Promoting Drugs for Members With Obstructive Sleep Apnea

Clinical criteria for approval of PA requests for non-preferred drugs in the stimulants, related agents – wake promoting class for members with OSA are all of the following:

The member is 18 years of age or older.
The member has EDS associated with OSA.
The member has had an overnight PSG sleep study with an AHI greater than or equal to five events per hour, confirming the member has OSA. The date of the PSG and the resulting AHI must be included with the PA request.
The member is not currently taking any other drugs in the stimulants class or the stimulants, related agents – wake promoting class.
The member is currently using CPAP and will continue to use CPAP in combination with the non-preferred stimulants, related agents – wake promoting drug.
At least one of the following is true:
- The member has tried armodafinil and experienced an unsatisfactory therapeutic response after the medication had been titrated to a maximum recommended daily dose.
- The member experienced a clinically significant adverse drug reaction with armodafinil.
- The member has a medical condition that prevents treatment with armodafinil.
- There is a clinically significant drug interaction with another medication the member is taking and armodafinil.
At least one of the following is true:
- The member has tried modafinil and experienced an unsatisfactory therapeutic response after the medication had been titrated to a maximum recommended daily dose.
- The member experienced a clinically significant adverse drug reaction with modafinil.
- The member has a medical condition that prevents treatment with modafinil.
- There is a clinically significant drug interaction with another medication the member is taking and modafinil.

Note: If requested by ForwardHealth, the provider is required to submit the test results and provider interpretation for the PSG.

If initial clinical criteria for non-preferred drugs in the stimulants, related agents – wake promoting class for members with OSA are met, PA requests may be approved for up to 183 days. Renewal PA requests for non-preferred stimulants, related agents – wake promoting drugs may be approved for up to 365 days.

Dose Limit for Armodafinil

A dose limit applies to armodafinil. The dose limit for armodafinil is 250 mg per day.

ForwardHealth will not consider dose limit overrides for armodafinil.

Dose Limit for Modafinil

A dose limit applies to modafinil. The dose limit for modafinil is 400 mg per day.

ForwardHealth will not consider dose limit overrides for modafinil.

Dose Limit for Sunosi

A dose limit applies to Sunosi. The dose limit for Sunosi is 150 mg per day.

ForwardHealth will not consider dose limit overrides for Sunosi.

Stimulants and Stimulants, Related Agents – Wake Promoting Quantity Limits

The following applies to drugs in the stimulants drug class and the stimulants, related agents – wake promoting drug class:

Armodafinil, modafinil, Sunosi, and all preferred and non-preferred stimulants (with the exception of liquid dosage forms) have a cumulative quantity limit of 136 units per month for drugs in the stimulants drug class and the stimulants, related agents – wake promoting drug class.
Members are limited to a combined total of 136 units (tablets, capsules, or patches) per month, an exception being members with narcolepsy.
Members with narcolepsy are allowed a quantity limit override to receive up to 136 units of stimulants in addition to 250 mg of armodafinil or 400 mg of modafinil or 150 mg of Sunosi per day.
Azstarys and Xelstrym also have a drug-specific quantity limit of 34 units per month.

The Quantity Limit Drugs and Diabetic Supplies data table contains the most current quantity limits.

Overriding the Stimulants and Stimulants, Related Agents – Wake Promoting Quantity Limit Policy

If it is medically appropriate for a member to exceed a quantity limit, pharmacy providers may request a quantity limit policy override by calling the DAPO Center.

Note: Providers are reminded that they may dispense up to the allowed quantity limit without contacting the DAPO Center.

Pharmacy providers may request a quantity limit policy override for members enrolled in BadgerCare Plus, Wisconsin Medicaid, or SeniorCare.

Lost or stolen medication
Vacation supply
Medication and/or dosage change by the prescriber

In addition, pharmacy providers may request a quantity limit policy override for members with narcolepsy. Members with narcolepsy are allowed a quantity limit override to receive up to 136 units of stimulants in addition to 250 mg of armodafinil per day or 400 mg of modafinil per day or 150 mg of Sunosi per day.

If the member does not meet the policy for a stimulants quantity limit override through the DAPO Center and the claim submitted exceeds the allowed stimulants quantity limit, the claim will be denied and the service will be a noncovered service. Members do not have appeal rights for noncovered services.

Topic #22578

Ulcerative Colitis

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

PA is required for non-preferred drugs.

Velsipity and Zeposia

Velsipity and Zeposia for members with ulcerative colitis require clinical PA.

Note: Zeposia is also a non-preferred drug in the MS agents drug class. PA requests for Zeposia, as a non-preferred MS agent, must be submitted with the Prior Authorization Drug Attachment for MS Agents form.

PA requests for Velsipity or Zeposia for members with ulcerative colitis must be completed, signed, and dated by the prescriber. PA requests for Velsipity or Zeposia for members with ulcerative colitis must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of Velsipity or Zeposia must be submitted with the PA request.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Velsipity or Zeposia for members with ulcerative colitis may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Velsipity and Zeposia for Members With Ulcerative Colitis

Clinical criteria that must be documented for approval of a PA request for Velsipity or Zeposia for members with ulcerative colitis are all of the following:

The member has moderate to severe ulcerative colitis.
The prescription is written by a gastroenterologist or through a gastroenterology consultation.
The member has taken Humira for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
The member has taken Xeljanz for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Velsipity or Zeposia for members with ulcerative colitis. The supporting clinical information and medical records must document the following:

The member's medical condition being treated
Details regarding previous medication use
The member's current treatment plan

If the clinical criteria for Velsipity or Zeposia for members with ulcerative colitis are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Velsipity or Zeposia for members with ulcerative colitis may be approved for up to 365 days. Renewal PA requests for members who have ulcerative colitis must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in symptoms compared to the member's baseline prior to the initiation of the non-preferred drug.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

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