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Dupixent®

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

January 2018

Therapeutic area - Atopic Dermatitis

Initial approval criteria

  • Patient must be at least 18 years of age AND
  • Must be prescribed by a provider specializing in dermatology AND
  • Provider’s specialty must be provided at time of request
  • Patient must have a diagnosis of moderate to severe atopic dermatitis with at least one of the following: 
    • Involvement of at least 10% of body surface area (BSA) OR 
    • Scoring Atopic Dermatitis (SCORAD) score of 20 or more OR
    • Investigator’s Global Assessment (IGA) with a score ≥ 3 OR
    • Eczema Area and Severity Index (EASI) score of ≥ 16 OR
    • Incapacitation due to AD lesion location (e.g., head and neck, palms, soles, or genitalia) AND
  • Patient must have a prior documented trial and failure (or contraindication) of ALL of the following:
    • Six-week trial of non-continuous use of 1 topical corticosteroids of medium to high potency (e.g., mometasone, fluocinolone) defined as having two consecutive prescription topical corticosteroid fills during the last 42 days AND 
    • Six-week trial of non-continuous use of 1 topical calcineurin inhibitors (tacrolimus or pimecrolimus) defined as having two consecutive topical calcineurin inhibitor fills during the last 42 days AND 
    • Three-month trial of continuous use of at least 1 immunosuppressive systemic agent (e.g., cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, etc.) AND
    • Three-month trial of phototherapy (e.g., psoralens with UVA light [PUVA], UVB, etc) provided patient has reasonable access to photo treatment AND 
  • Documentation that patient is not pregnant
  • Patient has not been given a live vaccine within 4 months from the time of request
  • Initial approval is for 6 months

Renewal approval criteria

  • Patient continues to meet initial approval criteria AND
  • Patient does not have documented toxicity from the agent (e.g., 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 (e.g., head and neck, palms, soles, or genitalia)
  • Renewal approval criteria is for 6 months

Denial criteria

  • Pregnancy
  • Concurrent administration with live vaccine

Quantity limits

  • First 28 days: 3 prefilled single-dose syringes 
  • Subsequent 28 days: 2 prefilled single-dose syringes

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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