Prior Authorization : Services Requiring Prior Authorization

Anti-Obesity Drugs

PA requests for the following anti-obesity drugs must be submitted on the Prior Authorization Drug Attachment for Anti-Obesity Drugs form:

• Benzphetamine
• Diethylpropion
• Phendimetrazine
• Phentermine
• Evekeo
• Saxenda
• Wegovy
• Xenical
• Zepbound

Anti-obesity drugs are covered for dual eligibles enrolled in a Medicare Part D PDP.

Submitting Prior Authorization Requests for Anti-Obesity Drugs

Prescribers, or their designees, are required to request PA for anti-obesity drugs using one of the following options:

• DAPO Center
• Portal
• Fax
• Mail

A prescriber, or their designee, should have all PA information completed before calling the DAPO Center to obtain PA.

Prescribers are required to retain a completed copy of the Prior Authorization Drug Attachment for Anti-Obesity Drugs form and any supporting documentation.

If a prescriber or their designee chooses to submit a paper PA request for anti-obesity drugs by fax or mail, the following must be completed and submitted to ForwardHealth:

• PA/RF
• Prior Authorization Drug Attachment for Anti-Obesity Drugs form
• Supporting documentation, as appropriate

The Prior Authorization Fax Cover Sheet is available on the Forms page of the Portal for prescribers or their designee submitting the forms and documentation by fax.

Prescribers are reminded that they are required to complete, sign, and date the PA/RF and the Prior Authorization Drug Attachment for Anti-Obesity Drugs form when submitting the PA request on paper.

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.

Clinical Criteria for Anti-Obesity Drugs

Clinical criteria for approval of a PA request for anti-obesity drugs require one of the following:

• The member is 18 years of age or older (or 12 years of age or older for Evekeo requests only) and has a BMI greater than or equal to 30.
• The member is 18 years of age or older (or 12 years of age or older for Evekeo requests only), has a BMI greater than or equal to 27 but less than 30 and has two or more of the following risk factors:
• Coronary heart disease
• Dyslipidemia
• Hypertension
• Sleep apnea
• Type 2 diabetes mellitus

For Saxenda PA requests for members 12–17 years of age, the member has a body weight above 132 pounds and a BMI corresponding to 30 or greater for adults by international cut-offs.

Note: BMI is determined using International Obesity Task Force BMI cut-offs for obesity by sex and age for pediatric patients aged 12 years and older (Cole Criteria).

For Wegovy and Xenical PA requests for members 12–17 years of age, the member has a BMI greater than or equal to the 95th percentile standardized by age and sex.

In addition, all of the following must be true:

• The member is not pregnant or nursing.
• The member does not have a history of an eating disorder (for example, anorexia, bulimia, or binge eating disorder).
• The prescriber has evaluated and determined that the member does not have any medical or medication contraindications to treatment with the anti-obesity drug being requested.
• For controlled substance anti-obesity drugs, the member does not have a medical history of substance abuse or misuse.
• The member has participated in a weight loss treatment plan (for example, nutritional counseling, an exercise regimen, or a calorie-restricted diet) in the past six months and will continue to follow the treatment plan while taking an anti-obesity drug.

PA requests for anti-obesity drugs will not be renewed if a member's BMI is below 24.

PA requests for anti-obesity drugs will only be approved for one anti-obesity drug per member. ForwardHealth does not cover treatment with more than one anti-obesity drug.

ForwardHealth does not cover the following:

• Orlistat, generic Xenical
• Any brand name innovator single ingredient phentermine products
• OTC anti-obesity drugs
• Anti-obesity drugs when used for conditions other than weight loss

ForwardHealth will return PA requests for the above-listed drugs as noncovered services.

Initial and Renewal PA Requests for Benzphetamine, Diethylpropion, Phendimetrazine, and Phentermine

If clinical criteria for anti-obesity drugs are met, initial PA requests for benzphetamine, diethylpropion, phendimetrazine, and phentermine will be approved for up to 90 days. If the member meets a weight loss goal of at least 10 pounds of their weight from baseline during the initial 90-day approval, PA may be requested for an additional three months of treatment. The maximum length of continuous drug therapy for benzphetamine, diethylpropion, phendimetrazine, and phentermine is six months.

If the member does not meet a weight loss goal of at least 10 pounds of their weight from baseline during the initial 90-day approval or the member has completed six months of continuous benzphetamine, diethylpropion, phendimetrazine, or phentermine treatment, then the member must wait six months before PA can be requested for any controlled substance anti-obesity drug.

ForwardHealth allows only two weight loss attempts with this group of drugs (benzphetamine, diethylpropion, phendimetrazine, and phentermine) during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Evekeo

If clinical criteria for anti-obesity drugs are met, initial PA requests for Evekeo will be approved for up to 30 days. The maximum length of continuous drug therapy for Evekeo is one month.

After the member has completed one month of Evekeo treatment, the member must wait six months before PA can be requested for any controlled substance anti-obesity drug.

ForwardHealth allows only two weight loss attempts with Evekeo during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Saxenda

If clinical criteria for anti-obesity drugs are met, initial PA requests for Saxenda will be approved for up to 180 days. If the member meets a weight loss goal of at least 5 percent of their weight from baseline, PA may be requested for an additional 180 days of treatment. PA requests for Saxenda may be approved for up to a maximum treatment period of 12 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 5 percent of their weight from baseline during the initial 180-day approval or the member has completed 12 months of continuous Saxenda treatment, then the member must wait six months before PA can be requested for Saxenda.

ForwardHealth allows only two weight loss attempts with Saxenda during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Wegovy

If clinical criteria for anti-obesity drugs are met, initial PA requests for Wegovy will be approved for up to 180 days. If the member meets a weight loss goal of at least 5 percent of their weight from baseline, PA may be requested for an additional 180 days of treatment. PA requests for Wegovy may be approved for up to a maximum treatment period of 12 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 5 percent of their weight from baseline during the initial 180-day approval or the member has completed 12 months of continuous Wegovy treatment, then the member must wait six months before PA can be requested for Wegovy.

ForwardHealth allows only two weight loss attempts with Wegovy during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Xenical

If clinical criteria for anti-obesity drugs are met, initial PA requests for Xenical will be approved for up to 180 days. If the member meets a weight loss goal of at least 10 pounds of their weight from baseline during the first six months of treatment, PA may be requested for an additional 180 days of treatment. If the member's weight remains below baseline, subsequent PA renewal periods for Xenical are a maximum of 180 days. PA requests for Xenical may be approved for a maximum treatment period of 24 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 10 pounds during the initial 180-day approval, the member's weight does not remain below baseline, or the member has completed 24 months of continuous Xenical treatment, then the member must wait six months before PA can be requested for Xenical.

ForwardHealth allows only two weight loss attempts with Xenical during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Initial and Renewal PA Requests for Zepbound

If clinical criteria for anti-obesity drugs are met, initial PA requests for Zepbound will be approved for up to 180 days. If the member meets a weight loss goal of at least 5 percent of their weight from baseline, PA may be requested for an additional 180 days of treatment. PA requests for Zepbound may be approved for up to a maximum treatment period of 12 continuous months of drug therapy.

If the member does not meet a weight loss goal of at least 5 percent of their weight from baseline during the initial 180-day approval or the member has completed 12 months of continuous Zepbound treatment, then the member must wait six months before PA can be requested for Zepbound.

ForwardHealth allows only two weight loss attempts with Zepbound during a member's lifetime. Additional PA requests will not be approved. ForwardHealth will return additional PA requests to the prescriber as noncovered services. Members do not have appeal rights for noncovered services.

Crinone

PA requests for Crinone may be approved for the treatment of secondary amenorrhea.

Although Crinone is also indicated for use in ART treatment, ForwardHealth does not cover infertility treatment, including ART.

PA requests for Crinone for the treatment of secondary amenorrhea must be submitted using Section VI (Clinical Information for Drugs with Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA and the PA/RF.

PA requests for Crinone for the treatment of secondary amenorrhea may be submitted on the ForwardHealth Portal, by fax, or by mail. PA requests for Crinone may not be submitted using the STAT-PA system.

Clinical Criteria for Crinone

Crinone may be used for the treatment of the following conditions:

• Secondary amenorrhea
• Prevention of preterm labor in women with a current singleton pregnancy and either short cervical length or a history of preterm labor

Although Crinone is also indicated for use in ART treatment, ForwardHealth does not cover infertility treatment, including ART.

For Members Who Have Secondary Amenorrhea

Secondary amenorrhea is the cessation of menses for six or more months in a woman who previously had normal menstrual cycles. Women who are pregnant, breastfeeding, or in menopause are not considered to have secondary amenorrhea.

Clinical criteria that must be documented for approval of a PA request for Crinone for members who have secondary amenorrhea are all of the following:

• The member has secondary amenorrhea.
• The member's last menstrual cycle occurred more than six months ago.
• The member is not being treated for infertility.
• The member is not pregnant or breastfeeding.
• The member is not in menopause.
• The member is currently receiving estrogen therapy.

Crinone 4% will only be approved for every-other-day dosing up to a total of six doses.

In women who fail to respond to a trial of Crinone 4%, Crinone 8% will only be approved for every-other-day dosing up to a total of six doses.

Crinone 8% for Women with a Current Singleton Pregnancy and Either Short Cervical Length or a History of Preterm Labor

ForwardHealth covers Crinone 8% for daily dosing through 36 weeks gestation in women with a current singleton pregnancy and either short cervical length or a history of preterm labor.

PA is not required for coverage of Crinone 8% in these situations; however, providers are required instead to follow the procedures for Diagnosis-Restricted Drugs.

Cystic Fibrosis Drugs Containing Ivacaftor

Clinical PA is required for all cystic fibrosis drugs containing ivacaftor.

PA requests for cystic fibrosis drugs containing ivacaftor will only be approved for one cystic fibrosis drug containing ivacaftor per member. ForwardHealth does not cover treatment with more than one cystic fibrosis drug containing ivacaftor.

PA requests for cystic fibrosis drugs containing ivacaftor should be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

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

Clinical criteria that must be documented for approval of a PA request for cystic fibrosis drugs containing ivacaftor are all of the following:

• The member has cystic fibrosis.
• The member's age is consistent with the FDA-approved indication for the use of the specific cystic fibrosis drug containing ivacaftor.
• The member has a gene mutation consistent with the FDA-approved indication for the use of the specific cystic fibrosis drug containing ivacaftor. (Note: A copy of the gene mutation test results must be included with an initial PA request.)

A copy of the member's medical records must be submitted with all PA requests for cystic fibrosis drugs containing ivacaftor. Medical records should document the following:

• Current progress notes related to the member's cystic fibrosis treatment plan
• A copy of the member's current pulmonary function test results

Initial PA requests for cystic fibrosis drugs containing ivacaftor may be approved for up to 183 days.

Renewal PA requests require that the member has been adherent with their entire cystic fibrosis medication regimen and that there is documentation demonstrating the member has experienced clinical improvement with the prescribed cystic fibrosis drug containing ivacaftor. Renewal PA requests may be approved for up to a maximum of 365 days.

Dojolvi

Dojolvi requires clinical PA.

PA requests for Dojolvi must be completed, signed, and dated by the prescriber. PA requests for Dojolvi 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 Dojolvi 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. 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 Dojolvi may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Dojolvi

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

• The member has a confirmed diagnosis of a long-chain fatty acid oxidation disorder.
• The member has a dietary assessment and a complete dietary treatment plan that includes all of the following:
  • The member's height, weight, and estimated total daily caloric intake
  • A copy of the prescription order for Dojolvi
  • The target daily dosage of Dojolvi as a percentage of the member's total daily caloric intake

Note: Dojolvi is prescribed in milliliters, and the recommended target daily dosage is up to 35 percent of the member's total daily caloric intake divided into at least four doses.

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

• The member's medical condition being treated
• Details regarding previous medication use
• The member's current treatment plan
Topic #1414

Drugs That Require Paper Prior Authorization

Paper PA request submission is required to determine medical necessity for the following drugs. Diagnosis and information regarding the medical requirements for these drug categories must be provided on the PA request for members enrolled in BadgerCare Plus, Wisconsin Medicaid, and SeniorCare:

• Alitretinoin gel (when used to treat Kaposi's sarcoma lesions)
• BBG drugs
• BMN drugs
• Diagnosis-restricted drugs that require PA outside approved diagnoses
• Drugs without signed manufacturer rebate agreements^*
• Fertility enhancement drugs (when used to treat conditions other than infertility)
• Impotence treatment drugs (when used for a condition other than impotence)
• Unlisted or investigational drugs^*

^* SeniorCare does not cover prescription drugs, even with a PA request, that do not have a signed rebate agreement between the Wisconsin DHS and the manufacturer; however, these drug products may be covered for BadgerCare Plus or Wisconsin Medicaid members if a paper PA request is submitted.

Submitting Paper Prior Authorization Requests

Paper PA requests that are faxed to ForwardHealth will receive an adjudication response via telephone one business day after they are received. Providers who submit PA requests by mail should be aware that this option requires additional time for the PA request to reach ForwardHealth and for ForwardHealth to complete the adjudication process.

To avoid delayed adjudication, do not fax and mail duplicate copies of the same PA request forms.

Pharmacy providers may contact Provider Services to determine the status of any PA request that has been submitted.

Approved, Returned, and Denied Paper Requests

A paper PA request submitted to ForwardHealth may be approved, returned, or denied.

When a PA request is approved:

• The "approved" box on the PA/RF is checked.
• The grant and expiration dates are indicated.
• A signature and a date signed are indicated.
• A specific days' supply is indicated.

When a PA request is returned:

• The "return" box on the PA/RF is checked.
• An explanation for the return is indicated.

A PA request is returned because additional information is needed or because information on the request must be corrected. A returned PA request is not the same as a denied request. Providers should correct or add the missing information to the original PA request and resubmit it to BadgerCare Plus or SeniorCare.

When a PA request is denied:

• The "denied" box on the PA/RF is checked and an explanation is given.
• A signature and date signed are indicated.
Topic #13678

Fertility and Impotence Drugs

According to Wis. Admin. Code §§ DHS 107.10(2)(f) and DHS 107.10(2)(g), the following drugs require PA:

• Drugs identified by the Wisconsin DHS that are sometimes used to enhance the prospect of fertility in males or females, when proposed to be used for treatment of a condition not related to fertility
• Drugs identified by DHS that are sometimes used to treat impotence, when proposed to be used for the treatment of a condition not related to impotence

These types of drugs are not covered unless a paper PA request is submitted on the PA/DGA and the drug is being used to treat a condition unrelated to fertility or impotence.

Topic #22820

Hemgenix

Hemgenix requires clinical PA.

Hemgenix is covered and reimbursed under the pharmacy benefit. Providers should submit claims for Hemgenix to ForwardHealth using a noncompound drug claim. For specific questions about the billing or coverage of high cost, orphan, and accelerated approval drugs, providers may contact Provider Services or email DHSOrphanDrugs@dhs.wisconsin.gov.

Additional Requirements for Hemgenix

Physician-administered Hemgenix is reimbursed separately from physician and clinical services associated with the administration of Hemgenix. The pharmacy provider is required to establish a delivery process with the prescriber to ensure that physician-administered Hemgenix is delivered directly to the prescriber or an agent of the prescriber. Pharmacy providers may only submit a claim to ForwardHealth for Hemgenix that has been administered to a member. If Hemgenix has been dispensed for a member but the dose is not administered to the member, the prescriber is responsible for notifying the dispensing pharmacy. If ForwardHealth has paid the dispensing pharmacy for any portion of the dispensing of Hemgenix that is not administered to the member, the dispensing pharmacy is responsible for reversing any claims submitted to ForwardHealth.

Clinical Criteria for Hemgenix

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

• Hemgenix must be prescribed by a hematologist at a dose of 2 x 10¹³ genome copies (gc) per kilogram of body weight.
• The member has been diagnosed with Hemophilia B (congenital Factor IX deficiency).
• The member is 18 years of age or older.
• The member must currently be treated with Factor IX prophylaxis therapy.
• The member must have a current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
• The prescriber must include documentation of Factor IX inhibitor titer testing. In case of a positive test result for human Factor IX inhibitors, perform a re-test within approximately 2 weeks. If both the initial test and re-test results are positive, PA for Hemgenix will not be approved.
• The prescriber must include documentation of liver health assessments including, ALT, AST, ALP, total bilirubin, hepatic ultrasound, and hepatic elastography. If the member has radiological liver abnormalities and/or sustained liver enzyme elevations, documentation of a consultation with a hepatologist to assess eligibility for Hemgenix will be required.

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

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

Submitting PA Requests for Hemgenix

PA requests for Hemgenix must be completed, signed, and dated by the prescriber. PA requests for Hemgenix 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 Hemgenix 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. 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 Hemgenix may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Topic #17857

Hetlioz and Hetlioz LQ

Hetlioz and Hetlioz LQ require clinical PA.

PA requests for Hetlioz or Hetlioz LQ must be completed, signed, and dated by the prescriber. PA requests for Hetlioz or Hetlioz LQ 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 Hetlioz or Hetlioz LQ 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. 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 Hetlioz or Hetlioz LQ may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

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.

Conditions for Which PA Requests for Use of Hetlioz and Hetlioz LQ Will Be Considered for Review

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

• Non-24 (Hetlioz PA requests only)
• Nighttime sleep disturbances in SMS (Hetlioz and Hetlioz LQ PA requests)

Clinical Criteria for Hetlioz for Members With Non-24-Hour Sleep-Wake Disorder

Clinical criteria that must be documented for approval of a PA request for Hetlioz for members with Non-24 are all of the following:

• The member's age is consistent with the FDA-approved product labeling for Hetlioz.
• The member has Non-24.
• One of the following is true:
  • The member is totally blind (no light perception in either eye).
  • The member is sighted (has light perception in either eye), and the following documentation has been submitted:
    • The member has a history of insomnia, excessive daytime sleepiness, or both that alternates with time periods of being asymptomatic as the member rotates between alignment and misalignment with the environmental light-dark schedule.
    • The member's symptoms have been present for at least three months.
    • The member's daily sleep logs and actigraphy (for at least 14 days) have been submitted and demonstrate a gradual daily drift (typically later) in rest-activity patterns.
    • The member's symptoms are not better explained by another current sleep, medical, neurologic, mental, or substance abuse disorder or medication use.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Hetlioz. The supporting clinical information and the 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 Hetlioz are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Hetlioz may be approved for up to 365 days. Renewal PA requests for members who have Non-24 must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant increase in nighttime total sleep time or a decrease in daytime nap duration compared to the member's baseline prior to the initiation of Hetlioz.

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

Clinical Criteria for Hetlioz and Hetlioz LQ for Members With Nighttime Sleep Disturbances in Smith-Magenis Syndrome

Clinical criteria that must be documented for approval of a PA request for Hetlioz or Hetlioz LQ for members with nighttime sleep disturbances in SMS are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the drug requested.
• The member has nighttime sleep disturbances.
• The member has SMS.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Hetlioz or Hetlioz LQ. The supporting clinical information and the 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 Hetlioz or Hetlioz LQ are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Hetlioz or Hetlioz LQ may be approved for up to 365 days. Renewal PA requests for members who have nighttime sleep disturbances in SMS must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant improvement in nighttime sleep quality compared to the member's baseline prior to the initiation of Hetlioz or Hetlioz LQ.

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

Topic #22819

Imcivree

Submitting Prior Authorization Requests for Imcivree

PA requests for Imcivree must be completed, signed, and dated by the prescriber. PA requests for Imcivree 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 Imcivree 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. 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 Imcivree may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system or calling the DAPO Center).

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

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

• Monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency
• Monogenic or syndromic obesity due to BBS

Clinical Criteria for Imcivree for Members With Monogenic or Syndromic Obesity Due to Proopiomelanocortin, Proprotein Convertase Subtilisin/Kexin Type 1, or Leptin Receptor Deficiency

Clinical criteria that must be documented for approval of a PA request for Imcivree for members with monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency are all of the following:

• The prescription is written by an endocrinologist or geneticist or through an endocrinology or genetics consultation.
• The member's current height, weight, and BMI are documented.
• One of the following is true:
  • The member is 6–17 years of age and has a current weight greater than or equal to the 95th percentile using growth chart assessments. (Note: An age-appropriate growth chart must be included with the PA request.)
  • The member is 18 years of age or older with a BMI of greater than or equal to 30.
• The member has monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance. (Note: A copy of the genetic testing results must be submitted with the PA request.)
• The prescriber has evaluated the member and determined that the member does not have any medical or medication contraindications to treatment with Imcivree.

A copy of the member's current medical records must be submitted with all PA requests for Imcivree for members with monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency. 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 Imcivree for members with monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency are met, initial PA requests may be approved for up to 183 days. If members with monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency meet a weight loss goal of at least 5 percent of their weight from baseline or at least 5 percent of their BMI from baseline (for patients with continued growth potential) during the first 183 days of treatment, PA may be requested for an additional 365 days of treatment. If the member's weight or BMI (for patients with continued growth potential) remains at least 5 percent below the member's baseline weight or their BMI, subsequent PA renewal requests for Imcivree are a maximum of 365 days.

Clinical Criteria for Imcivree for Members With Monogenic or Syndromic Obesity Due to Bardet-Biedl Syndrome

Clinical criteria that must be documented for approval of a PA request for Imcivree for members with monogenic or syndromic obesity due to BBS are all of the following:

• The prescription is written by an endocrinologist or geneticist or through an endocrinology or genetics consultation.
• The member's current height, weight, and BMI are documented.
• One of the following is true:
  • The member is 6–17 years of age and has a current weight greater than or equal to the 97th percentile using growth chart assessments. (Note: An age-appropriate growth chart must be included with the PA request.)
  • The member is 18 years of age or older with a BMI of greater than or equal to 30.
• The member has monogenic or syndromic obesity due to BBS.
• The prescriber has evaluated the member and determined that the member does not have any medical or medication contraindications to treatment with Imcivree.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Imcivree for members with monogenic or syndromic obesity due to BBS. 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 Imcivree for members with monogenic or syndromic obesity due to BBS are met, initial PA requests may be approved for up to 365 days. If members with monogenic or syndromic obesity due to BBS meet a weight loss goal of at least 5 percent of their weight from baseline or at least 5 percent of their BMI from baseline (for patients aged less than 18 years) during the first 365 days of treatment, PA may be requested for an additional 365 days of treatment. If the member's weight or BMI (for patients aged less than 18 years) remains at least 5 percent below the member's baseline weight or their BMI, subsequent renewal PA requests for Imcivree are a maximum of 365 days.

Topic #21397

Jynarque

Jynarque requires clinical PA.

Clinical Criteria for Jynarque

The following clinical criteria must be met and documented for approval of a PA request for Jynarque:

• The member has ADPKD.
• The member is 18 years of age or older.
• The prescription is written by, or in consultation with, a nephrologist or kidney transplant specialist.
• The member has an eGFR equal to or greater than 25 mL/min per 1.73 m2.
• The member has a high risk for progression to ESRD due to one or more of the following:
  • A confirmed annual eGFR decline of at least 5 mL/min/1.73 m2 in one year
  • A confirmed annual eGFR decline of at least 2.5 mL/min/1.73 m2 per year over a period of five years
  • A greater than 5 percent increase in total kidney volume per year on at least three repeated measurements (via MRI or CT, each at least six months apart)
  • A truncated PDK1 mutation and early clinical signs (that is, hypertension, macroscopic hematuria, cyst infection, or flank pain before the age of 35)
  • A Mayo classification (height adjusted total kidney volume by CT or MRI and age) of class 1C, 1D, and 1E
  • Documentation of average kidney length greater than 16.5 cm per ultrasonography, CT, or MRI

A copy of the member's medical records must be submitted and should sufficiently document:

• The information listed in the clinical coverage criteria.
• Details regarding previous medication use.
• The member's current treatment plan.

Note: The safety and efficacy of Jynarque in adults over the age of 55 is not yet known.

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

Renewal PA Requests

Requests for renewal must meet the clinical criteria for initial PA approval and have documentation to support that there has been a decrease in the member's kidney disease progression. In order to confirm the necessary adherence, the claims history and medical records will be reviewed for all renewal requests. A copy of the pertinent medical records must be included with the PA request.

Submitting PA Requests for Jynarque

PA requests for Jynarque must be submitted using the PA/DGA form.

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

The prescriber is required to send the completed PA/DGA form to the pharmacy where the prescription will be filled. The pharmacy provider is required to complete a PA/RF and submit it, along with the PA/DGA form received from the prescriber, to ForwardHealth using the PA submission option most appropriate for the drug.

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

Leqvio

Leqvio is a physician-administered drug that requires clinical PA.

All PA requests for Leqvio must be submitted with a specific HCPCS "J" code, J1306 (Injection, inclisiran, 1 mg).

PA requests for Leqvio must be completed, signed, and dated by the prescriber. PA requests for Leqvio must be submitted using Section V (Clinical Information for Physician-Administered Drugs With Specific PA Criteria Addressed in the ForwardHealth Online Handbook) on the PA/PAD form. Clinical documentation supporting the use of Leqvio must be submitted with the PA request.

Prescribers are required to submit the completed PA/PAD form and a completed PA/RF to ForwardHealth.

PA requests for Leqvio 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 Leqvio Will Be Considered for Review

ForwardHealth will only consider PA requests for Leqvio to treat the following identified clinical conditions:

• Clinical ASCVD
• HeFH

Clinical Criteria for Leqvio for Members With Clinical Atherosclerotic Cardiovascular Disease

Clinical criteria that must be documented for approval of a PA request for Leqvio 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 has taken a PCSK9 inhibitor drug concurrently with a maximized 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 the maximally tolerated dose of a statin during treatment with Leqvio.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Leqvio. 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

If the clinical criteria for Leqvio are met, initial PA requests may be approved for the initial and three-month doses.

Renewal PA requests for Leqvio may be approved for up to two doses per year. 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 during treatment with Leqvio.

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 Leqvio for Members With Heterozygous Familial Hypercholesterolemia

Clinical criteria that must be documented for approval of Leqvio for members with HeFH are all of the following:

• The member's age is consistent with the FDA-approved product labeling for Leqvio.
• 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 has taken a PCSK9 inhibitor drug concurrently with a maximized 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 the maximally tolerated dose of a statin during treatment with Leqvio.

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

• 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 Leqvio are met, initial PA requests may be approved for the initial and three-month doses.

Renewal PA requests for Leqvio may be approved for up to two doses per year. 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 during treatment with Leqvio.

Long-Term Hereditary Angioedema Prophylactic Drugs

Clinical PA is required for long-term HAE prophylactic drugs. Orladeyo and Takhzyro are long-term HAE prophylactic drugs that require PA.

ForwardHealth does not cover treatment with more than one long-term HAE prophylactic drug at a time.

PA requests for long-term HAE prophylactic drugs must be completed, signed, and dated by the prescriber. PA requests for long-term HAE prophylactic 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.

The prescriber is required to send the completed PA/DGA form to the pharmacy where the prescription will be filled. The pharmacy provider is required to complete a PA/RF and submit it along with the PA/DGA form received from the prescriber. Prescribers should not submit the PA forms to ForwardHealth.

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

Clinical Criteria for Long-Term Hereditary Angioedema Prophylactic Drugs

The following clinical criteria must be met and documented for approval of a PA request for long-term HAE prophylactic drugs:

• The member has type I or type II HAE.
• HAE is documented based on evidence of a low C4 level, plus one of the following:
  • A low C1-INH antigenic level (C1-INH antigenic level below the lower limit of normal as defined by the laboratory performing the test)
  • A normal C1-INH antigenic level and a low C1-INH functional level (C1-INH functional level below the lower limit of normal as defined by the laboratory performing the test)
• The member is 12 years of age or older.
• The prescription is written by or in consultation with an allergist, immunologist, hematologist, or a physician who specializes in HAE or related disorders.
• Medications known to cause angioedema (for example, angiotensin-converting enzyme inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.
• The member has no signs of current acute angioedema but has a history of clinical symptoms and signs consistent with HAE.
• The member requires HAE prophylaxis as evidenced due to one or more of the following:
  • A history of at least one severe HAE attack per month (defined as an attack that significantly interrupts daily activities despite short-term treatment)
  • Disabling symptoms for at least five days per month
  • A history of laryngeal angioedema
• One of the following is true:
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction that prevents the use of Haegarda.
  • The member has a clinically significant drug interaction with Haegarda and another medication the member is taking, or the member has a medical condition(s) that prevents the use of Haegarda.

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

• The frequency, severity, and duration of the HAE attacks.
• The member's medical condition being treated.
• Details regarding previous medication use.
• The member's current treatment plan.

If the clinical criteria for long-term HAE prophylactic drugs are met, initial PA requests may be approved for up to 183 days. Renewal PA requests for long-term HAE prophylactic drugs may be approved for up to 365 days.

Renewal PA Requests for Long-Term Hereditary Prophylactic Drugs

Renewal PA requests must meet the clinical criteria for initial PA requests for long-term HAE prophylactic drugs and have documentation to support that the member has experienced a reduction in the frequency, severity, or duration of HAE attacks versus the member's baseline since starting treatment. A copy of the member's current medical records must be included with the PA request for a long-term HAE prophylactic drug.

Luxturna

Luxturna requires clinical PA.

Note: The Select High Cost, Orphan, and Accelerated Approval Drugs data table identifies select high cost, orphan, and accelerated approval drugs and interim billing and coverage information for these drugs. The table also identifies which drugs have specific PA or policy requirements. For specific questions about the billing or coverage of high cost, orphan, and accelerated approval drugs listed in the Select High Cost, Orphan, and Accelerated Approval Drugs data table, providers may contact Provider Services or email DHSOrphanDrugs@dhs.wisconsin.gov.

Clinical Criteria for Luxturna

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

• The member has a confirmed diagnosis of an inherited retinal dystrophy due to biallelic RPE65 mutations.
• The member has sufficient viable retinal cells (defined as an area of retinal thickness greater than 100 microns within the posterior pole) as measured by OCT.
• The member has remaining light perception in the eye(s) that will receive treatment.
• Luxturna is prescribed and administered by an ophthalmologist or retinal surgeon with experience providing subretinal injections.

If clinical criteria for Luxturna are met, PA requests may be approved on a unilateral basis for up to four weeks (one lifetime dose per eye). For consideration of continued therapy on the second eye, all of the following must apply:

• All clinical criteria for initial PA request approval must be met.
• Administration is planned within a close interval to the treatment of the first eye, but at least six days apart.
• The PA request is not for a repeat treatment of a previously treated eye.

Submitting PA Requests for Luxturna

For PA requests for Luxturna, 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 is required to complete a PA/RF and submit it, along with the PA/DGA form received from the prescriber, to ForwardHealth using the PA submission option most appropriate for the drug.

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

Misoprostol

PA requests for misoprostol must be submitted using Section VI (Clinical Information for Drugs with Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA and the PA/RF.

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

Clinical Criteria for Misoprostol

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

• The member is currently taking at least one NSAID.
• The member is not pregnant.
• Misoprostol is being prescribed to reduce the risk of an NSAID-induced gastrointestinal ulcer.

Misoprostol may be approved for up to a maximum of 365 days.

Note: Coverage of misoprostol may be covered in gynecological procedures. However, coverage of misoprostol in conjunction with gynecological conditions is only allowed through the medical benefit. Providers should refer to Online Handbook topics Procedure Codes (#2661) and Coverage Policy for Miscarriage Management (#22677) for more information.

Palynziq

Palynziq requires clinical PA.

Clinical Criteria for Palynziq

Clinical criteria that must be documented for approval of a PA request for Palynziq for the treatment of adult members 18 years of age or older with a documented diagnosis of PKU are all of the following:

• The member has blood Phe levels greater than 600 micromole/L on existing management (for example, restriction of dietary Phe and protein intake).
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with sapropterin (Kuvan).
  • There is a clinically significant drug interaction between another drug(s) the member is taking and sapropterin (Kuvan).
  • The member has a medical condition(s) that prevents the use of sapropterin (Kuvan).
• Blood Phe levels will be obtained every four weeks until a maintenance dose is established. The drug dose should be titrated to the lowest effective dose. Once a maintenance dose is established, Phe levels will be monitored every six months.
• A copy of the member's medical records must be submitted and should document the following:
  • The medical record contains sufficient documentation to satisfy the clinical coverage criteria above.
  • The medical record contains details regarding previous medication use.
  • The medical record describes the member's current treatment plan.

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

In addition to meeting the clinical criteria for initial PA request approval, renewal PA requests for Palynziq require the submission of medical records (for example, chart notes, laboratory values) with the most recent results to demonstrate at least one of the following:

• The member has achieved at least a 20 percent reduction in blood Phe level from pretreatment baseline.
• The member has achieved a blood Phe level less than or equal to 600 micromole/L.

Submitting PA Requests for Palynziq

For PA requests for Palynziq, 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 is required to complete a PA/RF and submit it, along with the PA/DGA form received from the prescriber, to ForwardHealth using the PA submission option most appropriate for the drug.

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

Personal Continuous Glucose Monitoring Devices and Accessories

PA is required for coverage of personal continuous glucose monitoring devices and transmitters, but it is not required for sensors.

Prior Authorization Approval Criteria

PA requests for personal continuous glucose monitoring devices and transmitters may be approved for members who meet all of the following criteria:

• The member has Type 1 and/or Type 2 diabetes mellitus.
• The member is 21 years of age or older.
• The member is insulin-treated with multiple daily administrations of insulin or a continuous subcutaneous insulin infusion pump.
• The member has the motivation to use a personal continuous glucose monitoring device on a near-daily basis and has the ability and readiness, as assessed by their medical team, to make appropriate adjustments to their treatment regimen from the trending information obtained from the continuous glucose monitoring device.
• The member is receiving in-depth diabetes education and is in regular close contact with their diabetes management team.

For members who do not have Type 1 and/or Type 2 diabetes, coverage of personal continuous glucose monitoring devices will be considered on a case-by-case basis and reviewed for medical necessity.

ForwardHealth will consider coverage of a personal continuous glucose monitoring device on a case-by-case basis for members under 21 years old who meet the above criteria despite appropriate modifications in insulin regimen. Success of a personal continuous glucose monitoring device is highly dependent on compliance, especially for members under 21 years old. Documentation for members under 21 years old must include an assessment by an endocrinologist or diabetes educator of readiness of the member to use the device on a near-daily basis, as well as clear documentation that the member or the member's caregiver is compliant with self-monitoring as described above.

ForwardHealth does not cover personal continuous glucose monitoring devices for conditions that do not have sufficient evidence of the efficacy of continuous glucose monitoring (for example, gestational diabetes).

Prior Authorization Documentation

All of the following must be included as part of a PA request for personal continuous glucose monitoring devices and/or accessories:

• A completed PA/RF
• A completed PA/DMEA
• Documentation of the member's diagnosis of Type 1 and/or Type 2 diabetes mellitus
• A written prescription from a licensed medical professional on the member's medical team
• The following information about the continuous glucose monitoring device:
  • Name of the manufacturer of the device
  • Make of the device
  • Statement regarding whether or not the device is FDA-approved
• A description of the member's compliance with a physician-ordered diabetic treatment plan, including regular self-monitoring and insulin-treated with multiple daily administrations of insulin or a continuous subcutaneous insulin infusion pump
• Documentation of member and/or caregiver in-person training and available ongoing support in sensor placement, transmitter hookup, and monitor calibration, and an assessment from a licensed medical professional on the member's medical team of the member's ability to self-manage treatment according to information obtained from the monitor

Prior Authorization for Drugs Outside ForwardHealth-Allowed Diagnoses

PA requests for drugs outside the ForwardHealth-allowed diagnoses must be submitted on paper using a PA/RF and a PA/DGA. The prescriber is required to complete the appropriate section(s) of the PA/DGA as it pertains to the drug being requested and submit peer-reviewed medical literature to support the proven efficacy of the requested use of the drug to the pharmacy where the prescription will be filled.

Roctavian

Roctavian requires clinical PA and is covered under the pharmacy benefit. Pharmacy providers should submit a pharmacy noncompound drug claim for Roctavian.

For questions about the billing or coverage of high cost, orphan, and accelerated approval drugs, providers may contact Provider Services or email dhsorphandrugs@dhs.wisconsin.gov.

Claim Requirements for Roctavian

Physician-administered Roctavian will be reimbursed separately from physician and clinical services associated with the administration of Roctavian.

The pharmacy provider is required to establish a delivery process with the prescriber to ensure that physician-administered Roctavian is delivered directly to the prescriber or an agent of the prescriber. Pharmacy providers may only submit a claim to ForwardHealth for Roctavian that has been administered to a member. If Roctavian has been dispensed for a member but the dose is not administered to the member, the prescriber is responsible for notifying the dispensing pharmacy. If ForwardHealth has paid the dispensing pharmacy for any portion of the dispensing of Roctavian that is not administered to the member, the dispensing pharmacy is responsible for reversing any claims submitted to ForwardHealth.

Clinical Criteria for Roctavian

The following clinical criteria that must be documented for approval of a PA request for Roctavian are all of the following:

• Roctavian must be prescribed by a hematologist at a dose of 6 x 1013 vector genomes per kilogram of body weight.
• The member is 18 years of age or older.
• The member has been diagnosed with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL) without pre-existing antibodies to AAV5.
• The prescriber must include documentation of testing for pre-existing antibodies to AAV5 using the FDA-approved companion diagnostic. If the companion diagnostic test is positive for antibodies to AAV5, PA for Roctavian will not be approved.
• The prescriber must include documentation of liver health assessments including ALT, AST, GGT, ALP, total bilirubin, INR, hepatic ultrasound and elastography, or laboratory assessments for liver fibrosis. If the member has radiological liver abnormalities and/or sustained liver enzyme elevations, documentation of a consultation with a hepatologist to assess eligibility for Roctavian will be required.

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

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

Submitting PA Requests for Roctavian

PA requests for Roctavian must be completed, signed, and dated by the prescriber. PA requests for Roctavian 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 Roctavian 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. 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 Roctavian may be submitted Portal, by fax, or by mail (but not using the STAT-PA system).

Select High Cost, Orphan, or Accelerated Approval Drugs

Prior Authorization Requirements for Select High Cost, Orphan, or Accelerated Approval Drugs

Select high cost, orphan, or accelerated approval drugs may require PA, but in some cases, ForwardHealth will not establish drug-specific clinical criteria. For PA requests for select high cost, orphan, or accelerated approval drugs without drug-specific clinical criteria, the prescriber is required to complete, sign, and date the PA/DGA form, using Section VII (Clinical Information for Other Drug Requests) 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 is required to complete a PA/RF and submit it, along with the PA/DGA form received from the prescriber, to ForwardHealth using the PA submission option most appropriate for the drug.

If a high cost, orphan, or accelerated approval drug requires PA, but drug-specific clinical criteria are not established, PA requests for these drugs require the submission of medical records (for example, chart notes, laboratory values) to support that the drug being prescribed is for an FDA-approved indication and is medically necessary as defined by Wis. Admin. Code § DHS 101.03(96m). The drug must be prescribed in a dose and manner consistent with FDA-approved product labeling. These PA requests will be reviewed on a case-by-case basis for medical necessity.

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

Note: For specific questions about the billing or coverage of high cost, orphan, and accelerated approval drugs listed in the Select High Cost, Orphan, and Accelerated Approval Drugs data table, providers may contact Provider Services or email DHSOrphanDrugs@dhs.wisconsin.gov.

Clinical Criteria for Select High Cost, Orphan, or Accelerated Approval Drugs

The Select High Cost, Orphan, and Accelerated Approval Drugs data table identifies high cost, orphan, and accelerated approval drugs that require PA to support that use will be for an FDA-approved indication; PA requests for these drugs will be reviewed on a case-by-case basis for medical necessity.

As new high cost, orphan, and accelerated approval drugs enter the market, ForwardHealth will use the Select High Cost, Orphan, and Accelerated Approval Drugs data table to identify whether or not these drugs require PA. For drugs that require PA, the table will indicate whether or not the drugs have drug-specific PA clinical criteria.

Skyrizi IV for Crohn's Disease

Skyrizi IV is a physician-administered drug that requires clinical PA.

All PA requests for Skyrizi IV must be submitted with a specific HCPCS "J" code, J2327 (Injection, risankizumab-rzaa, intravenous, 1 mg).

PA requests for Skyrizi IV must be completed, signed, and dated by the prescriber. PA requests for Skyrizi IV must be submitted using Section V (Clinical Information for Physician-Administered Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) on the PA/PAD form. Clinical documentation supporting the use of Skyrizi IV must be submitted with the PA request.

Prescribers are required to submit the completed PA/PAD form and a completed PA/RF to ForwardHealth. PA requests for Skyrizi IV 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 Skyrizi IV Will Be Considered for Review

ForwardHealth will only consider PA requests for Skyrizi IV to treat Crohn's disease.

Clinical Criteria for Skyrizi IV for Members With Crohn's Disease

Clinical criteria that must be documented for approval of a PA request for Skyrizi IV for members with Crohn's disease are all of the following:

• The member has Crohn's disease.
• The member has been diagnosed by a gastroenterologist.
• 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 prescriber has indicated the clinical reason(s) why Skyrizi IV is being requested.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Skyrizi IV. 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 member's current weight

If the clinical criteria for Skyrizi IV are met, PA requests will only be approved for the three intravenous induction doses.

Note: A separate PA request must be obtained for maintenance treatment with Skyrizi subQ solution. PA for Skyrizi subQ solution must be obtained through the pharmacy PA process.

Spinal Muscular Atrophy Drugs

Clinical PA is required for all SMA drugs.

ForwardHealth does not cover treatment with more than one SMA drug at a time. If a member is transitioning treatment from Spinraza to Evrysdi, a waiting period of 90 days from the last injection is required before starting Evrysdi. The member's current approved PA request for Spinraza will be enddated upon approval of Evrysdi. If a member is transitioning treatment from Evrysdi to Spinraza, the member's current approved PA request for Evrysdi will be enddated upon approval of Spinraza. If a member has previously received treatment with Zolgensma, a PA request for another SMA drug treatment will be denied.

Claims Submission for Spinal Muscular Atrophy Drugs

SMA drugs, including Evrysdi, will be covered and reimbursed under the pharmacy benefit. Providers should submit claims for SMA drugs to ForwardHealth using a noncompound drug claim. For specific questions about the billing or coverage of high cost, orphan, and accelerated approval drugs Sprinraza or Zolgensma, providers may contact Provider Services or email dhsorphandrugs@dhs.wisconsin.gov.

Additional Requirements for Physician-Administered Spinal Muscular Atrophy Drugs

Physician-administered SMA drugs (for example, Spinraza and Zolgensma) are reimbursed separately from physician and clinical services associated with the administration of the SMA drugs. The pharmacy provider is required to establish a delivery process with the prescriber to ensure that the physician-administered SMA drugs are delivered directly to the prescriber or an agent of the prescriber. Pharmacy providers may only submit a claim to ForwardHealth for the SMA drugs that have been administered to a member. If an SMA drug has been dispensed for a member but the dose is not administered to the member, the prescriber is responsible for notifying the dispensing pharmacy. If ForwardHealth has paid the dispensing pharmacy for any portion of the dispensing of an SMA drug that is not administered to the member, the dispensing pharmacy is responsible for reversing any claims submitted to ForwardHealth.

Evrysdi

Clinical Criteria for Evrysdi

The following clinical criteria must be met and documented for approval of a PA request for Evrysdi:

• Evrysdi is prescribed by a neurologist, pulmonologist, or other physician with expertise in treating SMA and in a manner consistent with the FDA-approved product labeling.
• The member receives medication counseling prior to initiating Evrysdi treatment, and the provider must comply with administration requirements per FDA labeling. (Medication must be dosed after a meal, patients are instructed to drink water after the dose is administered, and medication must be given within five minutes after it has been drawn up into the oral syringe.)
• The member has SMA type 1, 2, or 3, which has been confirmed by genetic testing (5q SMN1: homozygous mutation, homozygous gene deletion, or compound heterozygote).
• The member has at least two copies of the SMN2 gene.
• The prescriber submits exam values from at least one of the following exams (based on member age and motor ability) to establish a baseline motor ability:
  • HINE (infant to early childhood)
  • HFMSE
  • RULM test (non-ambulatory members)
  • CHOP INTEND
  • 6MWT (ambulatory members)
  • MFM32
• The prescriber indicates the member's pulmonary status, including any requirement for ventilator support.

ForwardHealth will consider coverage for Evrysdi on a case-by-case basis if any of the following circumstances are present for the member:

• Complete paralysis of the limbs
• Ventilator dependent for 16 or more hours per day (including non-invasive respiratory support)

A copy of the member's medical records must be submitted and should sufficiently document:

• The information listed in the clinical criteria for PA approval.
• Details regarding previous medication use.
• The member's current treatment plan.

ForwardHealth will deny PA requests for Evrysdi if any of the following circumstances are present:

• The member is currently involved in a clinical trial for an SMA drug.
• The member has received treatment with Zolgensma.
• The member is currently receiving treatment with Spinraza.
• The member is diagnosed with a non-SMN1 variant of SMA.

Initial PA requests for Evrysdi to treat SMA may be approved for up to 183 days.

Renewal PA Requests

In addition to meeting the clinical criteria for initial PA request approval, renewal PA requests for Evrysdi require the submission of medical records (for example, chart notes, assessment of neurological and motor function) with the most recent results (less than two months prior to the submission of the renewal PA request) documenting a positive clinical response to Evrysdi therapy from pretreatment baseline status as demonstrated by one or more of the following exams:

• HINE that demonstrates the following:
  • Improvement or maintenance of previous improvement of at least a two-point (or maximal score) increase in the ability to kick or improvement or maintenance of previous improvement of at least a one-point increase in any other HINE milestone (for example, head control, rolling, sitting, crawling), excluding voluntary grasp
  • Net positive improvement in condition, defined as building on previous improvement from the pretreatment baseline in a majority of the HINE motor milestones or achievement or maintenance of any new motor milestone(s) from the pretreatment baseline when the member would otherwise be unexpected to do so (for example, sit unassisted, stand, walk)
• HFMSE that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a three-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• RULM test that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a two-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• CHOP INTEND that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a four-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• MFM32:
  • Improvement or maintenance of previous improvement of at least a two-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so

Renewal PA requests for Evrysdi used to treat SMA may be approved for up to 365 days.

Submitting PA Requests for Evrysdi

PA requests for Evrysdi must be submitted using the PA/DGA form.

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

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

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

Spinraza

Clinical Criteria for Spinraza

The following clinical criteria must be met and documented for approval of a PA request for Spinraza:

• Spinraza is prescribed by a neurologist, pulmonologist, or other physician with expertise in treating SMA and in a manner consistent with the FDA-approved product labeling.
• The member has SMA type 1, 2, or 3, which has been confirmed by genetic testing (5q SMN1: homozygous mutation, homozygous gene deletion, or compound heterozygote).
• The member has at least two copies of the SMN2 gene.
• The prescriber submits exam values from at least one of the following exams (based on member age and motor ability) to establish a baseline motor ability:
  • HINE (infant to early childhood)
  • HFMSE
  • RULM test (non-ambulatory members)
  • CHOP INTEND
  • 6MWT (ambulatory members)
• The prescriber indicates the member's pulmonary status, including any requirement for ventilator support.

ForwardHealth will consider coverage for Spinraza on a case-by-case basis if any of the following circumstances are present for the member:

• Complete paralysis of the limbs
• Ventilator dependent for 16 or more hours per day (including non-invasive respiratory support)
• Pre-symptomatic infants who have not yet developed symptoms but have undergone genetic studies indicating a high likelihood of developing type 1, 2, or 3 SMA disease (that is, less than three copies of the SMN2 gene)

A copy of the member's medical records must be submitted and should sufficiently document:

• The information listed in the clinical criteria for PA approval.
• Details regarding previous medication use.
• The member's current treatment plan.

ForwardHealth will deny PA requests for Spinraza if any of the following circumstances are present:

• The member is currently involved in a clinical trial for an SMA drug.
• The member has received treatment with Zolgensma.
• The member is currently receiving treatment with Evrysdi.
• The member is diagnosed with a non-SMN1 variant of SMA.

Initial PA requests for Spinraza to treat SMA may be approved for up to 210 days to allow for up to five doses of Spinraza.

Renewal PA Requests

In addition to meeting the clinical criteria for initial PA request approval, renewal PA requests for Spinraza require the submission of medical records (for example, chart notes, assessment of neurological and motor function) with the most recent results (less than one month prior to the submission of the renewal PA request) documenting a positive clinical response to Spinraza therapy from pretreatment baseline status as demonstrated by one or more of the following exams:

• HINE that demonstrates the following:
  • Improvement or maintenance of previous improvement of at least a two-point (or maximal score) increase in the ability to kick or improvement or maintenance of previous improvement of at least a one-point increase in any other HINE milestone (for example, head control, rolling, sitting, crawling), excluding voluntary grasp
  • Net positive improvement in condition, defined as building on of previous improvement from the pretreatment baseline in a majority of the HINE motor milestones or achievement or maintenance of any new motor milestone(s) from the pretreatment baseline when the member would otherwise be unexpected to do so (for example, sit unassisted, stand, walk)
• HFMSE that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a three-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• RULM test that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a two-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• CHOP INTEND that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a four-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so

Renewal PA requests for Spinraza used to treat SMA may be approved for up to 365 days.

Submitting PA Requests for Spinraza

PA requests for Spinraza must be submitted using the PA/DGA form.

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

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

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

Zolgensma

Clinical Criteria for Zolgensma

The following clinical criteria must be met and documented for approval of a PA request for Zolgensma:

• Zolgensma is prescribed by a neurologist, pulmonologist, or other physician with expertise in treating SMA and in a manner consistent with the FDA-approved product labeling.
• The member is less than 2 years old.
• The member has SMA, type 1, 2, or 3, which has been confirmed, by genetic testing (5q SMN1: homozygous mutation, homozygous gene deletion, or compound heterozygote).
• The member has at least two copies of the SMN2 gene.
• The member does not have advanced SMA including, but not limited to, any of the following:
  • Complete paralysis of the limbs
  • Ventilator dependent for 16 or more hours per day (including non-invasive respiratory support)
• The prescriber submits the most recent pre-treatment anti-AAV9 antibody testing, demonstrating a titer ratio of less than 50 to 1.

A copy of the member's medical records must be submitted and should sufficiently document:

• The information listed in the clinical criteria for PA approval.
• Details regarding previous medication use.
• The member's current treatment plan.

Note: ForwardHealth covers one treatment per lifetime with Zolgensma for pediatric members less than 2 years of age.

ForwardHealth will deny PA requests for Zolgensma if any of the following circumstances are present:

• The member is currently involved in a clinical trial for an SMA drug.
• The member has received prior treatment with Zolgensma.
• The member is currently receiving treatment with Spinraza or Evrysdi.
  Note: If a member already has a current approved PA request for Spinraza or Evrysdi, ForwardHealth will enddate the Spinraza or Evrysdi PA request upon approval of Zolgensma.
• The member is diagnosed with a non-SMN1 variant of SMA.
• The member is over 2 years of age.

Submitting PA Requests for Zolgensma

PA requests for Zolgensma must be submitted using the PA/DGA form.

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

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

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

Standard Pharmacy Policy for Covered and Noncovered Drugs

PA Policy for Covered Drugs

BadgerCare Plus, Medicaid, and SeniorCare members who were started on a drug outside of ForwardHealth (for example, a patient assistance program, manufacturer samples, other insurance, or cash) or are currently taking a non-preferred drug will not be exempt from meeting ForwardHealth PA criteria for that drug (unless specifically identified).

Types of Drugs That May Require PA

The following are types of drugs that may require PA:

• BBG and BMN drugs
• Diagnosis-restricted drugs that require PA outside ForwardHealth-approved diagnoses
• Drugs that follow PDL PA policy
• Drugs with established clinical PA criteria outside the PDL
• Requests for drugs by out-of-state pharmacies (that is, not in-state or border-status providers)
• Select high cost, orphan, and accelerated approval drugs

Standard Criteria for Drugs That Require PA

ForwardHealth has established the following standard criteria that may apply to a drug that requires PA:

• The drug must be prescribed in a dose and manner consistent with FDA-approved product labeling.
• The following will not be considered as criteria to support the need for a drug requiring PA:
  • Nonadherence to previous prescribed drug treatment
  • Member or prescriber preference for the use of the drug
  • Member or prescriber preference for a less frequent dosing schedule

If applicable, the following will also not be considered as criteria to support the need for a drug requiring PA:

• Member fear of needles
• Member or prescriber preference for the use of an oral agent

Supporting clinical information and a copy of the member's current medical records may be required with some PA requests. 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

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

Regardless whether the provider submits the member's medical records, the applicable PA form must sufficiently document supporting clinical information that the member meets PA criteria. If the submitted PA form does not clearly identify how the member meets PA criteria, the PA request may be returned or denied by ForwardHealth as incomplete.

Noncovered Drugs

Some drugs are not covered by Wisconsin Medicaid, BadgerCare Plus, or SeniorCare.

• Drugs when used for cosmetic use (such as eflornithine [Vaniqa], hydroquinone)
• Drugs when used for hair growth (such as Olumiant)
• Less-than-effective drugs designated by the FDA
• Drugs without a manufacturer's rebate agreement
• Drugs when used to treat infertility (such as clomiphene, menotropins)
• Drugs when used to treat impotence (such as alprostadil, sildenafil)

Stelara IV for Crohn's Disease and Ulcerative Colitis

Stelara IV is a physician-administered drug that requires clinical PA.

All PA requests for Stelara IV must be submitted with a specific HCPCS "J" code, J3358 (Ustekinumab, for intravenous injection, 1 mg).

PA requests for Stelara IV must be completed, signed, and dated by the prescriber. PA requests for Stelara IV must be submitted using Section V (Clinical Information for Physician-Administered Drugs With Specific PA Criteria Addressed in the ForwardHealth Online Handbook) on the PA/PAD form. Clinical documentation supporting the use of Stelara IV must be submitted with the PA request.

Prescribers are required to submit the completed PA/PAD form and a completed PA/RF to ForwardHealth. PA requests for Stelara IV 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 Stelara Intravenous Will Be Considered for Review

ForwardHealth will only consider PA requests for Stelara IV to treat the following identified clinical conditions:

• Crohn's disease
• Ulcerative colitis

Clinical Criteria for Stelara IV for Members With Crohn's Disease

Clinical criteria that must be documented for approval of a PA request for Stelara IV for members with Crohn's disease are all of the following:

• The member has Crohn's disease.
• The member has been diagnosed by a gastroenterologist.
• 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 prescriber has indicated the clinical reason(s) why Stelara IV is being requested.

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

If the clinical criteria for Stelara IV are met, PA requests will only be approved for the IV induction dose.

Note: A separate PA request must be obtained for maintenance treatment with Stelara subQ solution. PA requests for Stelara subQ solution must be obtained through the pharmacy PA process.

Clinical Criteria for Stelara IV for Members With Ulcerative Colitis

Clinical criteria that must be documented for approval of a PA request for Stelara IV for members with ulcerative colitis are all of the following:

• The member has ulcerative colitis.
• The member has been diagnosed by a gastroenterologist.
• 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.
• The prescriber has indicated the clinical reason(s) why Stelara IV is being requested.

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

If the clinical criteria for Stelara IV are met, PA requests will only be approved for the IV induction dose.

Note: A separate PA request must be obtained for maintenance treatment with Stelara subQ solution. PA requests for Stelara subQ solution must be obtained through the pharmacy PA process.

Strensiq

Strensiq requires clinical PA. PA requests for Strensiq 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.

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

Clinical Criteria for Strensiq

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

• Perinatal/infantile-onset HPP
• Juvenile-onset HPP

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

• The member has perinatal/infantile-onset HPP or juvenile-onset HPP.
• The member was 18 years of age or younger at the onset of signs and/or symptoms of HPP.
• The member's current weight is provided.
• The member has clinical manifestations consistent with HPP (for example, skeletal abnormalities, respiratory problems, hypercalcemia, seizures).
• Findings on radiographic imaging support the diagnosis of HPP (for example, infantile rickets, alveolar bone loss, osteoporosis, low bone mineral content for age).
• The prescription is written by an endocrinologist or a provider who specializes in HPP.
• The member has a documented history of HPP-related skeletal abnormalities.
• The member has a serum alkaline phosphatase below the age-adjusted normal range.
• The member has a plasma pyridoxal-5'-phosphate level above the upper limit of normal.
• The member has a documented tissue-nonspecific alkaline phosphatase gene mutation.

Medical records must be provided to demonstrate the member meets the clinical criteria previously listed.

Note: A copy of the gene mutation testing must be included with an initial PA request.

If clinical criteria for Strensiq are met, initial PA requests may be approved for up to a maximum of 183 days.

Clinical criteria that must be documented for approval of an initial renewal PA request for Strensiq are all of the following:

• The member meets the clinical criteria for an initial PA request approval for Strensiq.
• The member has responded to treatment with Strensiq as evidenced by improvement in respiratory status, growth, or radiographic findings compared to their baseline prior to initiation of treatment with Strensiq.

Medical records must be provided to demonstrate that the member meets the clinical criteria previously listed.

Initial renewal PA requests for Strensiq may be approved for up to a maximum of 365 days.

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

• The member meets the clinical criteria for an initial PA request approval for Strensiq.
• The member has responded to treatment with Strensiq as evidenced by a sustained improvement in respiratory status, growth, or radiographic findings compared to their baseline prior to initiation of treatment with Strensiq.

Medical records must be provided to demonstrate that the member meets the clinical criteria previously listed.

Subsequent renewal PA requests for Strensiq may be approved for up to a maximum of 365 days.

Wakix

Wakix requires clinical PA.

PA requests for Wakix must be completed, signed, and dated by the prescriber. PA requests for Wakix must be submitted using Prior Authorization Drug Attachment for Wakix 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.

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

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

Clinical Criteria for Wakix

PA requests for Wakix will only be approved for use to treat the following symptoms of narcolepsy:

• Cataplexy
• EDS

Narcolepsy With Cataplexy

Clinical criteria for approval of a PA request for Wakix to treat narcolepsy with cataplexy are all of the following:

• The member has narcolepsy with cataplexy.
• The member is 18 years of age or older.
• The prescriber has reviewed the member's current medication list to evaluate for potential drug interactions (for example, CYP2D6 inhibitors, CYP3A4 inducers, and drugs that increase the QT interval).
• The member is not currently 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 daytime sleepiness.
• 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:
  • Total sleep time documented is at least 360 minutes.
  • The member experienced minimal sleep interruptions (for example, respiratory events or periodic leg movements).
  • 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.
  • Average sleep latency for all naps is eight minutes or less.
  • The member achieved at least two SOREMPs. A SOREMP period within 15 minutes of sleep onset on the preceding nocturnal PSG may replace one of the SOREMPs on the MSLT.
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with a stimulant.
  • The member has a medical condition(s) that prevents treatment with a stimulant.
  • There is a clinically significant drug interaction between another medication the member is taking and stimulants.
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response that occurred after the medication had been titrated to a maximum recommended daily dose or experienced a clinically significant adverse drug reaction with armodafinil or modafinil.
  • The member has a medical condition(s) that prevents treatment with armodafinil or modafinil.
  • There is a clinically significant drug interaction between another medication the member is taking and armodafinil or modafinil.
• The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction to at least one of the following:
  • TCA
  • SSRI
  • SNRI

Initial PA requests for Wakix may be approved for up to 183 days.

In addition to documenting the previously listed clinical information on the Prior Authorization Drug Attachment for Wakix form, medical records must be submitted with the PA request to support the member's condition of narcolepsy with cataplexy.

Renewal PA requests may be approved for up to 365 days. Medical records must be submitted demonstrating clinical improvement, including a decrease in cataplexy or a decrease in the member's EDS. A decrease in a member's EDS must be supported by an ESS questionnaire, MWT, or MSLT. Medical records must also reflect patient compliance with medication use.

Narcolepsy Without Cataplexy

Clinical criteria for approval of a PA request for Wakix to treat narcolepsy without cataplexy are all of the following:

• The member has narcolepsy without cataplexy.
• The member is 18 years of age or older.
• The prescriber has reviewed the member's current medication list to evaluate for potential drug interactions (for example, CYP2D6 inhibitors, CYP3A4 inducers, and drugs that increase the QT interval).
• The member is not currently 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 daytime sleepiness.
• 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:
  • Total sleep time documented is at least 360 minutes.
  • The member experienced minimal sleep interruptions (for example, respiratory events or periodic leg movements).
  • 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.
  • Average sleep latency for all naps is eight minutes or less.
  • The member achieved at least two SOREMPs. A SOREMP period within 15 minutes of sleep onset on the preceding nocturnal PSG may replace one of the SOREMPs on the MSLT.
  • The member has EDS that interferes with normal activities on a daily basis.
• An ESS questionnaire, MWT, or MSLT has been performed for the member, confirming that the member has EDS. (Note: Test results for the ESS questionnaire, the MWT, or MSLT must be submitted with the PA request.)
• The prescriber ruled out or treated the member for other causes of EDS including:
  • Other sleep disorders, including sleep apnea.
  • Chronic pain or illness that disrupts normal sleep patterns.
  • Mood disorders such as depression.
  • Caffeine or nicotine use causing poor quality of nighttime sleep.
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with a stimulant.
  • The member has a medical condition(s) that prevents treatment with a stimulant.
  • There is a clinically significant drug interaction between another medication the member is taking and stimulants.
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response that occurred after the medication had been titrated to a maximum recommended daily dose or experienced a clinically significant adverse drug reaction with armodafinil or modafinil.
  • The member has a medical condition(s) that prevents treatment with armodafinil or modafinil.
  • There is a clinically significant drug interaction between another medication the member is taking and armodafinil or modafinil.

Initial PA requests for Wakix may be approved for up to 183 days.

In addition to documenting the previously listed clinical information on the Prior Authorization Drug Attachment for Wakix form, medical records must be submitted with the PA request to support the member's condition of narcolepsy without cataplexy.

Renewal PA requests may be approved for up to 365 days. Medical records must be submitted demonstrating clinical improvement, including a decrease in the member's EDS. A decrease in a member's EDS must be supported by an ESS questionnaire, MWT, or MSLT. Medical records must also reflect patient compliance with medication use.

Xyrem and Xywav

Xyrem and Xywav require clinical PA.

PA requests for Xyrem or Xywav must be completed, signed, and dated by the prescriber. PA requests Xyrem or Xywav must be submitted using the Prior Authorization Drug Attachment for Xyrem and Xywav 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.

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

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

Quantity limits apply to Xyrem and Xywav. Members are limited to a maximum nightly dose of 18 mL (9 g) of Xyrem or Xywav, which is equivalent to 540 mL (270 g) of Xyrem or Xywav per month.

PA requests for Xyrem or Xywav will only be approved for one drug per member. ForwardHealth does not cover treatment with both Xyrem and Xywav.

Clinical Criteria for Xyrem and Xywav

PA requests for Xyrem or Xywav will only be approved to treat one of the following:

• Symptoms of narcolepsy:
• Cataplexy
• EDS
• Idiopathic hypersomnia

Narcolepsy With Cataplexy

Clinical criteria for approval of a PA request for Xyrem or Xywav to treat narcolepsy with cataplexy are all of the following:

• The member has narcolepsy with cataplexy.
• The member is 7 years of age or older.
• The member does not have a succinic semialdehyde dehydrogenase deficiency.
• The prescriber has counseled the member on the contraindication between Xyrem or Xywav and alcohol.
• The member has agreed to be abstinent from alcohol while being treated with Xyrem or Xywav.
• The member does not have a history of substance abuse, addiction, or diversion.
• The member is not currently 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 daytime sleepiness.
• 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 with cataplexy.
• The overnight PSG test results and provider interpretation have been submitted with the PA request and include documentation of the following:
  • Total sleep time documented is at least 360 minutes.
  • The member experienced minimal sleep interruptions (for example, respiratory events or periodic leg movements).
  • Provider interpretation indicates 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.
  • Average sleep latency for all naps is 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.
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with a stimulant.
  • The member has a medical condition(s) that prevents treatment with a stimulant.
  • There is a clinically significant drug interaction(s) with another medication(s) the member is taking and a stimulant.
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response that occurred after the medication had been titrated to a maximum recommended daily dose or experienced a clinically significant adverse drug reaction with armodafinil or modafinil.
  • The member has a medical condition(s) that prevents treatment with armodafinil or modafinil.
  • There is a clinically significant drug interaction(s) with another medication(s) the member is taking and armodafinil or modafinil.
• The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction to at least one of the following:
  • TCA
  • SSRI
  • SNRI

Note: The prescriber is required to submit detailed clinical justification for prescribing Xywav instead of Xyrem. The clinical information must document why the member cannot use Xyrem, including why it is medically necessary that the member receive Xywav instead of Xyrem.

Initial PA requests for Xyrem or Xywav to treat narcolepsy with cataplexy may be approved for up to 183 days.

In addition to documenting the previously listed clinical information on the Prior Authorization Drug Attachment for Xyrem and Xywav form, medical records must be submitted with the PA request to support the member's medical condition of narcolepsy with cataplexy.

Renewal PA requests may be approved for up to 365 days. Medical records must be submitted demonstrating clinical improvement, including a decrease in cataplexy or a decrease in the member's EDS. A decrease in a member's EDS must be supported by an ESS questionnaire, MWT, or MSLT. Medical records must also reflect patient compliance with medication use and safety precautions for Xyrem or Xywav.

Narcolepsy Without Cataplexy

Clinical criteria for approval of a PA request for Xyrem or Xywav to treat narcolepsy without cataplexy are all of the following:

• The member has narcolepsy without cataplexy.
• The member is 7 years of age or older.
• The member does not have a succinic semialdehyde dehydrogenase deficiency.
• The prescriber has counseled the member on the contraindication between Xyrem or Xywav and alcohol.
• The member has agreed to be abstinent from alcohol while being treated with Xyrem or Xywav.
• The member does not have a history of substance abuse, addiction, or diversion.
• The member is not currently 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 daytime sleepiness.
• 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 without cataplexy.
• The overnight PSG test results and provider interpretation have been submitted with the PA request and include documentation of the following:
  • Total sleep time documented is at least 360 minutes.
  • The member experienced minimal sleep interruptions (for example, respiratory events or periodic leg movements).
  • Provider interpretation indicates 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.
  • Average sleep latency for all naps is 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 has EDS that interferes with normal activities on a daily basis.
• An ESS questionnaire, MWT, or MSLT has been performed for the member, confirming that the member has EDS. (Note: Test results for the ESS questionnaire, MWT, or MSLT must be submitted with the PA request.)
• The prescriber ruled out or treated the member for other causes of EDS, including:
  • Other sleep disorders, including sleep apnea.
  • Chronic pain or illness that disrupts normal sleep patterns.
  • Mood disorders such as depression.
  • Caffeine or nicotine use causing poor quality of nighttime sleep.
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with a stimulant.
  • The member has a medical condition(s) that prevents treatment with a stimulant.
  • There is a clinically significant drug interaction(s) with another medication(s) the member is taking and a stimulant.
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response that occurred after the medication had been titrated to a maximum recommended daily dose or experienced a clinically significant adverse drug reaction with armodafinil or modafinil.
  • The member has a medical condition(s) that prevents treatment with armodafinil or modafinil.
  • There is a clinically significant drug interaction(s) with another medication(s) the member is taking and armodafinil or modafinil.

Note: The prescriber is required to submit detailed clinical justification for prescribing Xywav instead of Xyrem. The clinical information must document why the member cannot use Xyrem, including why it is medically necessary that the member receive Xywav instead of Xyrem.

Initial PA requests for Xyrem or Xywav to treat narcolepsy without cataplexy may be approved for up to 183 days.

In addition to documenting the previously listed clinical information on the Prior Authorization Drug Attachment for Xyrem and Xywav form, medical records must be submitted with the PA request to support the member's medical condition of narcolepsy without cataplexy.

Renewal PA requests may be approved for up to 365 days. Medical records must be submitted demonstrating clinical improvement, including a decrease in the member's EDS. A decrease in a member's EDS must be supported by an ESS questionnaire, MWT, or MSLT. Medical records must also reflect patient compliance with medication use and safety precautions for Xyrem or Xywav.

Idiopathic Hypersomnia

Clinical criteria for approval of a PA request for Xyrem or Xywav to treat idiopathic hypersomnia are all of the following:

• The member has idiopathic hypersomnia.
• The member is 18 years of age or older.
• The member does not have a succinic semialdehyde dehydrogenase deficiency.
• The prescriber has counseled the member on the contraindication between Xyrem or Xywav and alcohol.
• The member has agreed to be abstinent from alcohol while being treated with Xyrem or Xywav.
• The member does not have a history of substance abuse, addiction, or diversion.
• The member is not currently 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 daytime sleepiness.
• 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 idiopathic hypersomnia.
• The overnight PSG test results and provider interpretation have been submitted with the PA request and include documentation of the following:
  • Total sleep time documented is at least 360 minutes.
  • The member experienced minimal sleep interruptions (for example, respiratory events or periodic leg movements).
  • Provider interpretation indicates 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.
  • Average sleep latency for all naps is eight minutes or less.
  • The member achieved fewer than two SOREMPs or no SOREMPs if the REM sleep latency on the preceding nocturnal PSG was 15 minutes or less.
• The member has EDS that interferes with normal activities on a daily basis.
• An ESS questionnaire, MWT, or MSLT has been performed for the member, confirming that the member has EDS. (Note: Test results for the ESS questionnaire, MWT, or MSLT must be submitted with the PA request.)
• The prescriber ruled out or treated the member for other causes of EDS, including:
  • Other sleep disorders, including sleep apnea.
  • Chronic pain or illness that disrupts normal sleep patterns.
  • Mood disorders such as depression.
  • Caffeine or nicotine use causing poor quality of nighttime sleep.
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response that occurred after the medication had been titrated to a maximum recommended daily dose or experienced a clinically significant adverse drug reaction with armodafinil or modafinil.
  • The member has a medical condition(s) that prevents treatment with armodafinil or modafinil.
  • There is a clinically significant drug interaction(s) with another medication(s) the member is taking and armodafinil or modafinil.

Initial PA requests for Xyrem or Xywav to treat idiopathic hypersomnia may be approved for up to 183 days.

In addition to documenting the previously listed clinical information on the Prior Authorization Drug Attachment for Xyrem and Xywav form, medical records must be submitted with the PA request to support the member's medical condition of idiopathic hypersomnia.

Renewal PA requests may be approved for up to 365 days. Medical records must be submitted demonstrating clinical improvement, including a decrease in the member's EDS. A decrease in a member's EDS must be supported by an ESS questionnaire, MWT, or MSLT. Medical records must also reflect patient compliance with medication use and safety precautions for Xyrem or Xywav.

Voxzogo

Voxzogo requires clinical PA.

Clinical Criteria for Voxzogo

The following clinical criteria must be met and documented for approval of a PA request for Voxzogo:

• The member has achondroplasia.
• The member's current height, weight, and growth velocity has been provided.
• The provider has submitted evidence that the member has open epiphyses.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Voxzogo. 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 Voxzogo are met, initial PA requests may be approved for up to 183 days.

Renewal PA Requests

Renewal PA requests for Voxzogo may be approved for up to 183 days. Renewal PA requests must include copies of the member's current medical records demonstrating that the member had an increase in their growth velocity compared to their baseline prior to the initiation of Voxzogo.

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

Submitting PA Requests for Voxzogo

PA requests for Voxzogo must be submitted using the PA/DGA form.

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

The prescriber is required to send the completed PA/DGA form to the pharmacy where the prescription will be filled. The pharmacy provider is required to complete a PA/RF and submit it with the PA/DGA form received from the prescriber, to ForwardHealth using the PA submission option most appropriate for the drug.

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

Vyjuvek

Vyjuvek requires clinical PA and is covered under the pharmacy benefit. Pharmacy providers should submit a pharmacy noncompound drug claim for Vyjuvek.

For questions about the billing or coverage of high cost, orphan, and accelerated approval drugs, providers may contact Provider Services or email dhsorphandrugs@dhs.wisconsin.gov.

Claim Requirements for Vyjuvek

Physician-administered Vyjuvek will be reimbursed separately from physician and clinical services associated with the administration of Vyjuvek.

The pharmacy provider is required to establish a delivery process with the prescriber to ensure that physician-administered Vyjuvek is delivered directly to the prescriber, an agent of the prescriber, or a health care provider designated to administer Vyjuvek to the member. Pharmacy providers may only submit a claim to ForwardHealth for the Vyjuvek that has been administered to a member. If Vyjuvek has been dispensed for a member but the dose is not administered to the member, the prescriber or health care provider designated to administer Vyjuvek to the member is responsible for notifying the dispensing pharmacy. If ForwardHealth has paid the dispensing pharmacy for any portion of the dispensing of Vyjuvek that is not administered to the member, the dispensing pharmacy is responsible for reversing any claims submitted to ForwardHealth.

Clinical Criteria for Vyjuvek

The following clinical criteria must be met and documented for approval of a PA request for Vyjuvek:

• Vyjuvek must be prescribed by a dermatologist or wound care specialist.
• The member is 6 months of age or older.
• The member has been diagnosed with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain gene.
• The prescriber must include documentation of at least one cutaneous wound that is appropriate to be treated with Vyjuvek and confirm that the wound does not appear to be infected.
• The prescriber must include documentation of the size of the wound area(s) to be treated and confirm the calculated dose of Vyjuvek will not exceed the recommended maximum weekly dose.
• The prescriber must include documentation that the member's treatment plan includes the appropriate administration of Vyjuvek by a health care provider and the wound dressing care required for treatment with Vyjuvek.
• The prescriber must include documentation that the member's treatment plan addresses the requirement for Vyjuvek to be properly prepared at a pharmacy for administration to the member's wound(s) within eight hours of mixing of the Vyjuvek gel with the Vyjuvek biological suspension.

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

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

Submitting PA Requests for Vyjuvek

PA requests for Vyjuvek must be completed, signed, and dated by the prescriber. PA requests for Vyjuvek 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 Vyjuvek 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. 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 Vyjuvek may be submitted Portal, by fax, or by mail (but not using the STAT-PA system).