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Dupixent®

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

March 2019

Therapeutic area - Atopic Dermatitis, Asthma

Initial approval criteria

Atopic Dermatitis

  • 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 OR
  • Patient has not been given a live vaccine within 4 months from the time of request AND
  • Patient with co-morbid moderate to severe atopic dermatitis and asthma must meet the prior authorization criteria for at least one FDA-approved indication
  • Initial approval is for 6 months

Asthma

  • Patient must be at least 12 years of age AND
  • Patient must have a diagnosis of moderate to severe eosinophilic asthma with a documented blood eosinophiol count of either:
    • ≥150 cells/microliter at baseline or ≥ 300 cells/microliter in the past 12 months as documented in chart notes AND
  • Patient’s symptoms are not well controlled despite a 3-month adherent trial of high-dose inhaled corticosteroids in combination with a long-acting bronchodilator or leukotriene modifier AND
  • Patient has had 2 or more exacerbations requiring treatment with systemic corticosteroids in the past 12 months AND
  • Documentation that patient is not pregnant OR
  • Patient has not been given a live vaccine within 4 months from the time of request AND
  • Dupixent will NOT be prescribed as dual therapy with another monoclonal antibody for the treatment of asthma AND
  • At time of request, provide baseline FEV1 and frequency of asthma exacerbation per month AND
  • Patient with co-morbid moderate to severe atopic dermatitis and asthma must meet the prior authorization criteria for at least one FDA-approved indication
  • Initial approval will be for 6 months in duration

OR

  • Patient must be at least 12 years of age AND
  • Patient must have a diagnosis of moderate to severe asthma with a documented hospitalization or emergency medical care related to inadequate asthma control within the past 12 months AND
  • Patient’s symptoms are not well controlled despite a 3-month adherent trial of high-dose inhaled corticosteroids in combination with a long-acting bronchodilator or leukotriene modifier AND
  • Patient must have had at least one month of daily oral corticosteroid (at least 5 mg per day of prednisone/prednisolone or equivalent) within the last 3 months AND
  • Documentation that patient is not pregnant OR
  • Patient has not been given a live vaccine within 4 months from the time of request AND
  • Dupixent will NOT be prescribed as dual therapy with another monoclonal antibody for the treatment of asthma AND
  • At time of request, provide baseline FEV1 and frequency of asthma exacerbation per month AND
  • Patient with co-morbid moderate to severe atopic dermatitis and asthma must meet the prior authorization criteria for at least one FDA-approved indication
  • Initial approval will be for 6 months in duration

Renewal approval criteria

Atopic Dermatitis

  • 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

Asthma

  • Patient does not have documented toxicity from the agent (e.g., 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 will be for 12 months in duration

Quantity limits

Atopic Dermatitis

  • First 28 days: 3 prefilled single-dose (300mg/2mL) syringes
  • Subsequent 28 days: 2 prefilled single-dose (300mg/2mL) syringes

Asthma

  • First 28 days: 3 prefilled single-dose (300mg/2mL or 200mg/1.14 mL) syringes
  • Subsequent 28 days: 2 (300mg/2mL or 200mg/1.14mL) prefilled single-dose syringes
  • Request for syringes of two different strengths will not be approved

Questions?

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

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