Prior Authorization : Preferred Drug List

Immunomodulators, Atopic Dermatitis

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

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

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.

Cibinqo, Dupixent, and Rinvoq

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Clinical Criteria for Dupixent for Members With Eosinophilic Esophagitis

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Clinical Criteria for Dupixent for Members With Oral Corticosteroid Dependent Asthma

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

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

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

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

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

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

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

Clinical Criteria for Dupixent for Members With Prurigo Nodularis

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

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

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

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

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

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

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

Eucrisa and Opzelura for Atopic Dermatitis

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

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/PDL for Eucrisa and Opzelura for Atopic Dermatitis form and a completed PA/RF to ForwardHealth.

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

Clinical Criteria for Eucrisa and Opzelura for Atopic Dermatitis

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

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

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

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

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

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

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

Clinical Criteria for Opzelura for Members With Vitiligo

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

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

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

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

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

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

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