Dupixent®

Drug - Dupixent® (dupilumab) [sanofi-aventis]

September 2022

Therapeutic area - Atopic Dermatitis, Asthma, Chronic Rhinosinusitis with Nasal Polyposis (CRwNP)

Initial approval criteria

Patient has the diagnosis and age that are aligned with the FDA-approved indication AND
Dupixent is prescribed by, or in consultation with, a provider specializing in dermatology AND
Patient must have a prior documented trial and failure (or contraindication) of TWO of the following:
- A topical corticosteroid (for example, mometasone, fluocinolone) OR
- An oral corticosteroid OR
- Topical calcineurin inhibitor (tacrolimus or pimecrolimus) AND
Initial approval is for 6 months

Patient has the diagnosis and age that are aligned with the FDA-approved indication AND
Dupixent is prescribed by, or in consultation with, an asthma specialist
Dupixent will NOT be prescribed as dual therapy with another monoclonal antibody for the treatment of asthma AND
Patient must have a prior documented trial and failure (or contraindication) of a medium, high-dose, or maximally-tolerated inhaled conticosteroid-containing product AND one additional asthma controller medication AND
At time of request, provide baseline FEV1 and frequency of asthma exacerbation per month AND
Initial approval will be for 6 months

Patient has the diagnosis and age that are aligned with the FDA-approved indication AND
Must be prescribed by, or in consultation with, a provider specializing in allergy/immunology or ear, nose and throat (ENT) AND
Patient’s symptoms are not adequately controlled despite trials of intranasal and oral corticosteroid therapy AND
Initial approval is for 6 months

Patient continues to meet initial approval criteria AND
Patient does not have documented toxicity from the agent (for example, hypersensitivity, conjunctivitis, keratitis, immunogenicity) AND
Patient has documented response compared to baseline in at least one of the following measurements:
- BSA involvement OR
- Scoring Atopic Dermatitis (SCORAD) OR
- Investigator’s Global Assessment (IGA) OR
- Eczema Area and Severity Index (EASI) OR
- Incapacitation due to AD lesion location (for example, head and neck, palms, soles, or genitalia)
Renewal approval criteria is for 6 months

Patient does not have documented toxicity from the agent (for example, hypersensitivity, conjunctivitis, keratitis, immunogenicity) AND
Treatment has resulted in clinical improvement as documented by at least ONE of the following:
- Decreased frequency of exacerbations (defined as improvement of asthma as demonstrated by decreased daily dose of oral/systemic corticosteroids and/or less frequent hospitalizations and/or reduced frequency of ER visits)
- Improvement in lung function, measured in FEV1
Renewal approval is for 12 months

Patient does not have documented toxicity from the agent (for example, hypersensitivity, conjunctivitis, keratitis, immunogenicity) AND
Treatment has resulted in clinical improvement as documented by reduction of mucosal inflammation (on imaging or direct visualization)
Renewal approval is for 12 months

Quantity limits pursuant to the FDA-approved label will apply for all FDA-approved indications
When applicable, patient’s body weight (in kg) must be submitted at time of request

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