Dupixent Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

Dupixent will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of moderate-to-severe atopic dermatitis AND ALL of the following:
      1. The patient is at least 6 months of age
         AND
      2. ONE of the following:
         1. The patient has tried and failed a topical steroid (e.g., triamcinolone)
            OR
         2. The patient has an intolerance, hypersensitivity, or an FDA labeled contraindication to a topical steroid
            AND
      3. For patients 2 years of age or over, ONE of the following:
         1. The patient has tried and failed a topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus)
            OR
         2. The patient has an intolerance, hypersensitivity, or an FDA labeled contraindication to a topical calcineurin inhibitor
            AND
      4. The patient will NOT be using the requested medication in combination with another biologic medication or a JAK inhibitor for the requested indication (e.g., Adbry, Cibinqo, Opzelura, Rinvoq)
         OR
   2. The patient has a diagnosis of moderate-to-severe asthma with an eosinophilic phenotype or oral corticosteroid dependent asthma AND ALL of the following:
      1. The patient is at least 6 years of age
         AND
      2. The patient is currently being treated with AND will continue asthma control therapy (e.g., ICS, ICS/LABA, LRTA, LAMA, theophylline) in combination with the requested medication
         AND
      3. The patient will NOT be using the requested medication in combination with Xolair or with an injectable interleukin 5 (IL-5) inhibitor (e.g., Cinqair, Fasenra, Nucala) for the requested indication
         OR
   3. The patient has a diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) AND BOTH of the following:
      1. The patient is at least 12 years of age
         AND
      2. BOTH of the following:
         1. ONE of the following:
            1. The patient has tried and had an inadequate response to an oral systemic corticosteroid AND an intranasal corticosteroid (e.g., fluticasone)
               OR
            2. The patient has an intolerance, hypersensitivity, or an FDA labeled contraindication to an oral systemic corticosteroid AND an intranasal corticosteroid
               AND
         2. The patient will continue standard maintenance therapy (e.g., intranasal corticosteroid) in combination with the requested medication
            OR
   4. BOTH of the following:
      1. The patient has a diagnosis of eosinophilic esophagitis (EoE) confirmed by esophageal biopsy
         AND
      2. The patient is at least 1 year of age
   5. BOTH of the following:
      1. The patient has a diagnosis of prurigo nodularis (PN)
         AND
      2. The patient is at least 18 years of age
         OR
   6. The patient has a diagnosis of chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype AND ALL of the following:
      1. The patient is 18 years of age or over
         AND
      2. The patient is currently being treated with AND will continue COPD control therapy (e.g., ICS, LABA, LAMA) in combination with the requested medication
         AND
      3. The patient will NOT be using the requested medication in combination with Xolair or with an injectable interleukin 5 (IL-5) inhibitor (e.g., Cinqair, Fasenra, Nucala) for the requested indication
         AND
2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, dermatologist, immunologist, gastroenterologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
3. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months

Renewal Evaluation

Dupixent will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
   AND
2. ONE of the following:
   1. The patient has a diagnosis of moderate-to-severe atopic dermatitis and BOTH of the following:
      1. The patient is at least 6 months of age
         AND
      2. The patient will NOT be using the requested medication in combination with another biologic medication or a JAK inhibitor for the requested indication (e.g., Adbry, Cibinqo, Opzelura, Rinvoq)
         OR
   2. The patient has a diagnosis of moderate-to-severe asthma with an eosinophilic phenotype or oral corticosteroid dependent asthma AND ALL of the following:
      1. The patient is at least 6 years of age
         AND
      2. The patient is currently being treated with AND will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with the requested medication
         AND
      3. The patient will NOT be using the requested medication in combination with Xolair or with an injectable interleukin 5 (IL-5) inhibitor (e.g., Cinqair, Fasenra, Nucala) for the requested indication
         OR
   3. The patient has a diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) AND BOTH of the following:
      1. The patient is at least 12 years of age
         AND
      2. The patient will continue standard maintenance therapy (e.g., intranasal corticosteroid) in combination with the requested medication
         OR
   4. BOTH of the following:
      1. The patient has a diagnosis of eosinophilic esophagitis (EoE)
         AND
      2. The patient is at least 1 year of age
   5. BOTH of the following:
      1. The patient has a diagnosis of prurigo nodularis (PN)
         AND
      2. The patient is at least 18 years of age
         OR
   6. The patient has a diagnosis of chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype AND ALL of the following:
      1. The patient is 18 years of age or over
         AND
      2. The patient is currently being treated with AND will continue COPD control therapy (e.g., ICS, LABA, LAMA) in combination with the requested medication
         AND
      3. The patient will NOT be using the requested medication in combination with Xolair or with an injectable interleukin 5 (IL-5) inhibitor (e.g., Cinqair, Fasenra, Nucala) for the requested indication
         AND
3. The patient has had clinical benefit with the requested medication
   AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, dermatologist, immunologist, gastroenterologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
5. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months