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 immunomodulators, atopic dermatitis drugs.

PA requests for non-preferred immunomodulators, atopic dermatitis drugs will only be approved for use to treat the identified clinical conditions:

• AFRS
• Atopic dermatitis
• BP
• COPD
• CRSwNP
• CSU
• EoE
• Eosinophilic asthma
• Oral corticosteroid dependent asthma
• Prurigo nodularis

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

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

Note: If a member has more than one clinical condition for which ForwardHealth will approve a non-preferred immunomodulators, atopic dermatitis drug, and the provider would like to bypass the required trial of a ForwardHealth-preferred biologic drug, the provider must submit complete medical records for the clinical conditions. Additionally, the provider must clearly identify on the PA/DGA form that the member has more than one clinical condition for which the non-preferred drug is approved and provide justification for bypassing the required ForwardHealth-preferred biologic drug. ForwardHealth will use the member's complete clinical picture to evaluate the PA request.

PA requests for non-preferred immunomodulators, atopic dermatitis drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred immunomodulators, atopic dermatitis drugs must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of non-preferred immunomodulators, atopic dermatitis drugs 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 non-preferred immunomodulators, atopic dermatitis drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Information is available about general ForwardHealth policy for drugs that require PA approval. This includes what may not be considered criteria to support the need for a drug.

PA requests will not be considered for subcutaneous dosage forms of immunomodulators, atopic dermatitis drugs that will be administered in a medical office or medical facility.

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Allergic Fungal Rhinosinusitis

Dupixent is a non-preferred drug used to treat AFRS.

Clinical criteria that must be documented for approval of a PA request for non-preferred drugs used to treat AFRS are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the requested drug.
• The prescription is written by or through consultation with an allergist or an ear, nose, and throat specialist.
• The member has AFRS with a history of sino-nasal surgery.
• The member was appropriately treated with post-surgical glucocorticoids and has been compliant with therapy.
• The results of a sinus CT study showing nasal polyposis with opacification of one or more sinuses must be submitted.
• The member will not use the requested drug in combination with any biologic immunomodulator.

If the clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred immunomodulators, atopic dermatitis drugs may be approved for up to 365 days. Renewal PA requests for members who have AFRS must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in AFRS symptoms.

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

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Atopic Dermatitis

Adbry and Ebglyss are preferred drugs used to treat atopic dermatitis. Preferred drugs do not require PA.

Cibinqo, Dupixent, Nemluvio, and Rinvoq are non-preferred drugs used to treat atopic dermatitis.

Clinical criteria that must be documented for approval of a PA request for non-preferred drugs for members with 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.
• One of the following is true:
  • The member is 6 months–11 years old (Dupixent PA requests).
  • The member is 12–20 years of age and has taken Adbry or Ebglyss for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
  • The member is 21 years of age or older and has taken both Adbry and Ebglyss at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.

If the clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred immunomodulators, atopic dermatitis drugs 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.

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Bullous Pemphigoid

Dupixent is a non-preferred drug used to treat BP.

Clinical criteria that must be documented for approval of a PA request for non-preferred drugs used to treat BP are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the requested drug.
• The member has moderate to severe BP.
• The prescription is written by or through consultation with a dermatologist.
• Exacerbating factors that may contribute to the member's BP, 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 taken a high-potency topical corticosteroid and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
  • The member has taken doxycycline and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
• The member has taken oral corticosteroids 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.

If the clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred immunomodulators, atopic dermatitis drugs may be approved for up to 365 days. Renewal PA requests for members who have BP must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in BP symptoms.

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

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Chronic Obstructive Pulmonary Disease

Dupixent is a non-preferred drug used to treat COPD.

Clinical criteria that must be documented for the approval of non-preferred drugs used to treat COPD are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the drug requested.
• The member has COPD with an eosinophilic phenotype. A baseline blood eosinophil count of greater than 300 cells/mcL within the previous three months must be documented.
• The prescription is written by or through consultation with a COPD specialist (for example, an allergist, an immunologist, or a pulmonologist).
• The member has a history of two or more COPD exacerbations that required treatment with systemic corticosteroids and/or antibiotics, or an emergency department visit or hospitalization for the treatment of COPD in the past year. Documentation should include the approximate dates and what interventions took place for each exacerbation.
• The member's baseline FEV1 is 30–70% 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 COPD treatment regimen, including triple therapy with a LAMA, LABA, and ICS for at least three months prior to requesting Dupixent. Documentation should include the LAMA, LABA, and ICS names, doses, and start dates.
• Exacerbating factors that may contribute to the member's COPD, 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.

If the clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred immunomodulators, atopic dermatitis drugs may be approved for up to 365 days. Renewal PA requests for members who have COPD 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 COPD exacerbations or an increase in FEV1 percent predicted. Members must also continue to take their maximized COPD treatment regimen, including a LAMA, LABA, and ICS.

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

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Chronic Rhinosinusitis With Nasal Polyposis

Dupixent is a non-preferred drug used to treat CRSwNP.

Clinical criteria that must be documented for approval of a PA request for non-preferred drugs used to treat CRSwNP are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the requested drug.
• The member has CRSwNP.
• The prescription is written by or through consultation with an allergist or an ear, nose, and throat specialist.
• The member has been adherent to and maintained on a maximized CRSwNP treatment regimen, including an INCS for at least three months prior to requesting Dupixent. Documentation should include the CRSwNP drug treatment names, doses, and start dates.
• At least one of the following is true:
  • The member is 12–17 years old.
  • The member is 18 years of age or older and 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 is 18 years of age or older and has a serum IgE level less than 30 IU/mL. A current serum IgE level completed within the past 90 days must be submitted.
• The member will not use the requested drug in combination with any biologic immunomodulator.

If clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred immunomodulators, atopic dermatitis drugs may be approved for up to 365 days. Renewal PA requests for members who have CRSwNP must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in CRSwNP symptoms. Members must also continue to take their maximized CRSwNP treatment regimen, including the INCS.

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

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Chronic Spontaneous Urticaria

Dupixent and Rhapsido are non-preferred drugs used to treat CSU.

Clinical criteria that must be documented for approval of a PA request for non-preferred drugs used to treat CSU are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the requested drug.
• The member has CSU.
• The prescription is written by or through consultation with an allergist or a dermatologist.
• The member has taken the maximum dose of an H1 antihistamine for at least two consecutive weeks and remains symptomatic. The H1 antihistamine name, dose, and dates taken must be documented.
• 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.

If clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred immunomodulators, atopic dermatitis drugs may be approved for up to 365 days. Renewal PA requests for members who have CSU must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in CSU symptoms.

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

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Eosinophilic Asthma

Dupixent is a non-preferred drug used to treat eosinophilic asthma.

Clinical criteria that must be documented for approval of a PA request for non-preferred drugs used to treat eosinophilic asthma are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the requested drug.
• The member has eosinophilic asthma. 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% 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.
• The member 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.

If the clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

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

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

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Eosinophilic Esophagitis

Dupixent is a non-preferred drug used to treat EoE.

Clinical criteria that must be documented for approval of a PA request for a non-preferred drug used to treat EoE are all of the following:

• The member's age and weight are consistent with the FDA-approved product labeling for the requested drug.
• 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.

If the clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred immunomodulators, atopic dermatitis drugs 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).

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

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Oral Corticosteroid Dependent Asthma

Dupixent is a non-preferred drug used to treat oral corticosteroid dependent asthma.

Clinical criteria that must be documented for approval of a PA request for a non-preferred drug used to treat oral corticosteroid dependent asthma are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the requested drug.
• 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.

If the clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred immunomodulators, atopic dermatitis drugs 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. Members must also continue to take their maximized asthma treatment regimen, including an ICS and a LABA.

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

Clinical Criteria for Immunomodulators, Atopic Dermatitis Drugs for Prurigo Nodularis

Dupixent and Nemluvio are non-preferred drugs used to treat prurigo nodularis.

Clinical criteria that must be documented for approval of a PA request for non-preferred drugs used to treat prurigo nodularis are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the requested drug.
• 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 a topical treatment(s) to reduce itching and inflammation for at least two months and experienced an unsatisfactory therapeutic response.
  • The member has used a topical 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.

If the clinical criteria for non-preferred immunomodulators, atopic dermatitis drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for non-preferred immunomodulators, atopic dermatitis drugs 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.

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