Dupilumab (Dupixent®)

OFFICE / HOME HEALTH / SELF ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
  • Add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma (limitation of use: not for the relief of acute bronchospasm or status asthmaticus)

Patient's must meet the following criteria for the indication(s) above:

Moderate-to-severe Atopid Dermatitis:

  • Prescribed by or in collaboration with a dermatologist, AND
  • Chart note documentation required documenting diagnosis of moderate-to-severe atopic dermatitis, drugs tried and failed and reason for failure, AND
  • 12 years or older; AND
  • Member has an Investigator's Global Assessment (IGA) score of 3 or 4; AND
  • Exacerbating factors that could contribute to the member's atopic dermatitis have been evaluated and addressed (e.g., non-compliance with therapy, environmental triggers, allergy patch testing, etc.); AND
  • Tried and failed all of the following (note: failure is defined as the member being refractory to daily treatment for at least 1 month for topical corticosteroids and 6 weeks for topical calcineurin inhibitor or maximum duration recommended by the product's prescribing information:
    • At least one medium to very high potency topical corticosteroid, AND
    • At least one topical calcineurin inhibitor (Elidel, Protopic), AND
    • At least one oral DMARD (e.g., cyclosporin), AND
  • Member will not use Dupixent concomitantly with other biologics (e.g., Xolair, Remicade, Enbrel, Nucala, etc.), AND
  • Member does not have a parasitic infection
  • Reauthorization criteria:

  • Member has had a clinical reduction in body surface area (BSA) affected, AND
  • Member has had a clinical reduction in pruritus and flares, AND
  • Member has had an improvement of at least 2 points on the IGA from initiation of treatment, AND
  • Member will not use Dupixent concomitantly with other biologics (e.g., Xolair, Remicade, Enbrel, Nucala, et.c)

Moderate-to-severe Asthma:

  • Prescribed by or in collaboration with an allergist, immunologist, or pulmonologist, AND
  • Chart note documentation required documenting diagnosis of moderate-to-severe asthma, AND
  • 12 years or older, AND
  • Patient meets one of the following criteria:
    • Patient has a blood eosinophil level of at least 150 cells per microliter within the previous 6 weeks or within 6 weeks prior to treatment with any anti-interleukin (IL) therapy (e.g., Dupixent, Nucala, Cinqair, Fasenra); OR
    • Patient has oral (systemic) corticosteroid-dependent asthma (e.g., has received at least 5 mg oral prenisone or equalent per day for at least 6 months), per the prescribing physician, AND
  • Patient has received at least 3 consecutive months of combination therapy with BOTH of the following (1 and 2):
    • 1)  An inhaled corticosteroids (ICS) [e.g. Flovent Diskus/HFA, ArmonAir RespiClick, Arnuity Ellipta, Asmanex Twisthaler/HFA, Aersopan, Alvesco, Pulmicort Flexhaler, budesonide suspension for inhalation {Pulmicort Respules, generics}, Qvar/Qvar Redihaler]; AND
    • 2)  At least ONE of the following:
      • Inhaled long-acting beta-agonist (LABA) [e.g., Serevent Diskus]; OR
      • Inhaled long-acting muscarinic antagonist (LAMA) [e.g., Spiriva Respimat]; OR
      • Leukotriene receptor antagonist (LTRA) [ e.g. montelukast, zafirlukast]; OR
      • Theophylline, AND
  • Patient's asthma is uncontrolled or was uncontrolled prior to starting any anti-IL therapy as defined by ONE of the following:
    • The patient experienced two or more asthma exacerbations requireing treatment with systemic corticosteroids in the previous year; OR
    • The patient experienced one or more asthma exacerbation requiring hospitalization or an Emergency Department (ED) visit in the previous year; OR
    • Patient has a forced expiratory volume in 1 second (FEV1) < 80% predicted; OR
    • Patient has an FEV1/forced vital capacity (FVC) < 0.80; OR
    • The patient's asthma worsens upon tapering or oral corticosteroid therapy
    •  
  • Reauthorization criteria: patients must meet the following criteria (1, 2, and 3):
    • 1) The patient has already received at least 6 months of therapy with Dupixent, AND
    • 2) Patient continues to receive therapy with one inhaled corticosteroid (ICS) or one ICS-containing combination inhaler (e.g., Flovent Diskus/HFA, ArmonAir RespiClick, Arnuity Ellipta, Asmanex Twisthaler/HFA, Aerospan, Alvesco, Pulmicort Flexhaler, budesonide suspension for inhalation, Qvar/Qvar Redihaler, Advair Diskus/HFA, AirDuo RespiClick, Symbicort, Breo Ellipta, and Dulera), AND
    • 3) The patient has responded to Dupixent therapy as determined by the prescribing physician (e.g., decreased asthma exacerbations; decreased asthma symptoms; decreased hospitalizations, emergency department (ED)/urgent care, or physician visits due to asthma; decreased requirement for oral corticosteroid therapy)

Dosing:

  • Atopic dermatitis:
    • Adults: Initial dose of 600 mg (two 300mg injections), followed by 300 mg given every other week
    • Adolescents (12 to 17 years of age):
      • <60 kg: initial 400mg, followed by 200 mg every other week
      • 60 kg or more: initial 600 mg (two 300 mg injections), followed by 300 mg every other week
    • Dupixent can be used with or without topical corticosteroids.  Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.
  • Asthma:
    • Initial 400 mg followed by 200 mg every other week OR
    • Initial 600 mg followed by 300 mg every other week
    • For patients with oral corticosteroids-dependent asthma, or with co-morbid moderate-to-severe atopic dermatitis for which Dupixent is indicated, start with an initial dose of 600 mg followed by 300 mg every other week

Approval:

  • Atopic dermatitis: Initial: 4 months
  • Asthma: Initial: 6 months
  • Renewal (Atopic dermatitis or Asthma): 1 year

Last review date: July 10, 2019