WHA

DUPIXENT (dupilumab)

Office-Administration – subcutaneous injection

Self-Administration – subcutaneous injection

 

Diagnosis considered for coverage:

 

  • Atopic Dermatitis (AD) - for the treatment of adult and pediatric patients aged 6 months 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. Dupixent can be used with or without topical corticosteroids. 
  • Asthma - as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. 
  • Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) - as an add-on maintenance treatment in adult patients with inadequately controlled CRSwNP. 
  • Eosinophilic Esophagitis (EoE) - for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with EoE.
  • Prurigo Nodularis (PN) - for the treatment of adult patients with prurigo nodularis (PN).
  •  
Coverage criteria:

 

For diagnosis of moderate-to-severe atopic dermatitis (AD):

  • Patient has a documented diagnosis of moderate to severe atopic dermatitis; AND
  • Patient is 6 months of age or older; AND
  • Prescribed by or in consultation with a dermatologist or allergist/immunologist; AND
  • Patient has one of the following:
    • Involvement of at least 10% body surface area (BSA) 
    • SCORing Atopic Dermatitis (SCORAD) index value of at least 25; AND
  • Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to at least ONE of the following:
    • Medium or higher potency topical corticosteroid 
    • Pimecrolimus cream 
    • Tacrolimus ointment 
    • Eucrisa (crisaborole) ointment

 

For diagnosis of eosinophilic asthma:

  • Patient has a documented diagnosis of moderate to severe asthma; AND
  • Patient is 6 years of age or older; AND
  • Prescribed by or in consultation with a pulmonologist or allergist/immunologist; AND
  • Asthma is an eosinophilic phenotype as defined by a baseline (pre-treatment) peripheral blood eosinophil level greater than or equal to 150 cells per microliter; AND
  • Patient meets one of the following:
    • Patient has had at least two or more asthma exacerbations requiring systemic corticosteroids (e.g., prednisone) within the past 12 months
    • Prior asthma-related hospitalization within the past 12 months; AND
  • Patient has paid claims or is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
    • Both of the following:
      • High-dose inhaled corticosteroid (ICS) (i.e., greater than 500 mcg fluticasone propionate equivalent/day) 
      • Additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], tiotropium)
    • One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate/salmeterol], Symbicort [budesonide/formoterol], Breo Ellipta [fluticasone/vilanterol])

 

For diagnosis of oral corticosteroid dependent asthma:

  • Patient has a documented diagnosis of moderate to severe asthma; AND
  • Patient is 6 years of age or older; AND
  • Prescribed by or in consultation with a pulmonologist or allergist/immunologist; AND
  • Patient is currently dependent on oral corticosteroids for the treatment of asthma; AND
  • Patient has paid claims or is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
    • Both of the following:
      • High-dose inhaled corticosteroid (ICS) (i.e., greater than 500 mcg fluticasone propionate equivalent/day) 
      • Additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], tiotropium)
    • One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate/salmeterol], Symbicort [budesonide/formoterol], Breo Ellipta [fluticasone/vilanterol])

 

For diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP):

  • Patient is 18 years of age or older, AND
  • Patient has a documented diagnosis of chronic rhinosinusitis with nasal polyposis, AND
  • Prescribed by or in consultation with an allergist, immunologist, pulmonologist, or otolaryngologist, AND
  • Unless contraindicated, the patient has had an inadequate response to 2 months of treatment with an intranasal corticosteroid (e.g., fluticasone, mometasone); AND
  • Dupixent will be used in combination with another agent for CRSwNP

 

For diagnosis of eosinophilic esophagitis (EoE):

  • Patient has a documented diagnosis of eosinophilic esophagitis (EoE); AND
  • Prescribed by or in consultation with a gastroenterologist or allergist/immunologist, AND
  • Patient is 12 years of age or older; AND
  • Patient weighs at least 40 kg; AND
  • Patient has symptoms of esophageal dysfunction (e.g., dysphagia, food impaction, gastroesophageal reflux disease [GERD]/heartburn symptoms, chest pain, abdominal pain), AND
  • Patient has at least 15 intraepithelial eosinophils per high power field (HPF), AND
  • Other causes of esophageal eosinophilia have been excluded, AND
  • Trial and failure, contraindication, or intolerance to at least an 8-week trial of ONE of the following:
    • Proton pump inhibitors (e.g., pantoprazole, omeprazole) 
    • Topical (esophageal) corticosteroids (e.g., budesonide, fluticasone) 

 

For diagnosis of prurigo nodularis (PN):

  • Patient has a documented diagnosis of prurigo nodularis (PN); AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with a dermatologist or allergist/immunologist, AND
  • Patient has at least 20 nodular lesions, AND
  • Trial and failure, contraindication, or intolerance to one previous PN treatment (e.g., topical corticosteroids, topical calcineurin inhibitors [pimecrolimus, tacrolimus], topical capsaicin)

 

Reauthorization Criteria:

 

For the diagnosis of moderate-to-severe atopic dermatitis (AD):

  • Documentation of a positive clinical response to therapy as evidenced by at least ONE of the following:
    • Reduction in BSA involvement from baseline 
    • Reduction in SCORAD index value from baseline; AND
  • Prescribed by or in consultation with a dermatologist or allergist/immunologist

 

For diagnosis of eosinophilic asthma:

  • Documentation of a positive clinical response to therapy (e.g., reduction in exacerbations, improvement in FEV1, decreased use of rescue medications); AND
  • Patient continues to be treated with an inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide) with or without additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], tiotropium) unless there is a contraindication or intolerance to these medications; AND
  • Prescribed by or in consultation with a pulmonologist or allergist/immunologist

 

For diagnosis of oral corticosteroid dependent asthma:

  • Documentation of a positive clinical response to therapy (e.g., reduction in exacerbations, improvement in FEV1, decreased use of rescue medications); AND
  • Patient continues to be treated with an inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide) with or without additional asthma controller medication (e.g., leukotriene receptor antagonist [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], tiotropium) unless there is a contraindication or intolerance to these medications; AND
  • Prescribed by or in consultation with a pulmonologist or allergist/immunologist

 

For diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP):

  • Documentation of a positive clinical response to therapy (e.g., reduction in nasal polyps score [NPS; 0-8 scale], improvement in nasal congestion/obstruction score [NC; 0-3 scale]); AND
  • Dupixent will be used in combination with another agent for CRSwNP; AND
  • Prescribed by or in consultation with an allergist/immunologist, pulmonologist, or otolaryngologist

 

For diagnosis of eosinophilic esophagitis (EoE):

  • Documentation of a positive clinical response to therapy as evidenced by improvement of at least ONE of the following from baseline:
    • Symptoms (e.g., dysphagia, food impaction, heartburn, chest pain) 
    • Histologic measures (e.g., esophageal intraepithelial eosinophil count) 
    • Endoscopic measures (e.g., edema, furrows, exudates, rings, strictures); AND
  • Prescribed by or in consultation with a gastroenterologist or allergist/immunologist 

 

For diagnosis of prurigo nodularis (PN):

  • Documentation of a positive clinical response to therapy as evidenced by at least ONE of the following:
    • Reduction in the number of nodular lesions from baseline 
    • Improvement in symptoms (e.g., pruritus, inflammation) from baseline; AND
  • Prescribed by or in consultation with a dermatologist or allergist/immunologist 

 

Dosing:

 

  • AD:
    • Adults: Initial dose of 600 mg (two 300mg injections), followed by 300 mg given every other week
    • Pediatrics (6 years to 17 years of age):
      • 15 to <30 kg: initial 600 mg (two 300 mg injections), followed by 300 mg every 4 weeks
      • 30 kg to <60 kg: initial 400 mg (two 200 mg injections), 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
    • Pediatrics (6 months to 5 years of age):
      • 5 to less than 15 kg: 200 mg (one 200 mg injection) every 4 weeks
      • 15 to less than 30 kg: 300 mg (one 300 mg injection) every 4 weeks
      • For pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended
    • 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:
    • Adult and Pediatric Patients 12 Years and Older:
      • 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 corticosteroid-dependent asthma, or with co-morbid moderate-to-severe atopic dermatitis, or adults with co-morbid chronic rhinosinusitis with nasal polyposis 
      • Initial 600 mg followed by 300 mg every other week
    • Pediatric Patients 6 Years to 11 Years of Age:
      • 15 to less than 30 kg: 100 mg every other week OR 300 mg every four weeks
      • 30 kg or more: 200 mg every other week
      • For pediatric patients 6 to 11 years of age with asthma, no initial loading dose is recommended
      • For pediatric patients 6 to 11 years of age with asthma and co-morbid moderate-to severe AD, follow the recommended dosage for pediatric patients 6 years to 17 years of age with atopic dermatitis which includes an initial loading dose
  • CRSwNP:
    • 300 mg once every other week
  • EoE:
    • 300 mg once every week (QW)
  • PN: 
    o    Initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week (Q2W).

 

Coverage Duration:

 

  • AD:
    • Initial: 6 months
    • Reauthorization: 1 year
  • Eosinophilic and oral corticosteroid dependent asthma:
    • Initial: 6 months
    • Reauthorization: 1 year
  • CRSwNP:
    • Initial: 1 year
    • Reauthorization: 1 year
  • EoE:
    • Initial: 1 year
    • Reauthorization: 1 year
  • PN: 
    • Initial: 6 months
    • Reauthorization: 1 year

 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:
  • Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of Dupixent. Decrease steroids gradually, if appropriate.
  • Treat pre-existing helminth infections before initiating Dupixent. If patients become infected while receiving Dupixent and do not respond to anti-helminth treatment, discontinue Dupixent until the infection resolves
  • Avoid use of live vaccines 
  • The Scoring Atopic Dermatitis (SCORAD) index is a clinical tool for assessing the severity of atopic dermatitis lesions based on affected body area and intensity of plaque characteristics. [10, 11] The extent and severity of AD over the body area (A) and the severity of 6 specific symptoms (erythema, edema/papulation, excoriations, lichenification, oozing/crusts, and dryness) (B) are assessed and scored by the Investigator. Subjective assessment of itch and sleeplessness is scored by the patient (C). The SCORAD score is a combined score (A/5 + 7B/2 + C) with a maximum of 103. Higher scores indicate greater severity/worsened state. A score of 25 to 50 indicates moderate disease severity and greater than 50 indicates severe disease.
  • Other agents used for CRSwNP include intranasal corticosteroids and nasal saline

 

Policy Updates:
  • 5/23/2017 – New policy approved by P&T.
  • 1/15/2019 – New criteria for new indication for moderate-to-severe asthma
  • 7/16/2019 – New criteria for new indication for chronic rhinosinusitis with nasal polyposis
  • 1/3/2022 – Updated criteria and dosing for moderate-to-severe asthma. Criteria changed to age 6 years or older to reflect change to indication
  • 5/17/2022 – Update to age requirement for moderate-to-severe asthma indication
  • 12/1/2022 – New criteria for new indication for eosinophilic esophagitis
  • 3/1/2023 – New criteria for new indication for prurigo nodularis
  • 6/1/2023 – Class review for atopic dermatitis and severe asthma. Updates to PA requirements for indications. Separated out eosinophilic asthma and oral corticosteroid dependent asthma. Updated initial coverage duration for AD from 4 months to 6 months. Updated initial coverage duration for CRSwNP from 6 months to 1 year

 

References:

1. Dupixent Prescribing Information. Sanofi-Aventis U.S. LLC. Bridgewater, NJ. September 2022. 
2.  Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014; 71(1):116-32. 
3.  Institute for Clinical and Economic Review (ICER). Biologic therapies for treatment of asthma associated with type 2 inflammation: effectiveness, value, and value-based price benchmarks. https://icer.org/wp-content/uploads/2020/10/ICER_Asthma-Final-Report_Unredacted_08122020.pdf. Published December 20, 2018. Accessed March 2, 2021. 
4.  Wenzel S, Castro M, Corren J, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high dose inhaled corticosteroids plus a long-acting B2 agonist: a randomized double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388:31-44. 
5.  Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018; 378(26):2486-96. 
6.  Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018; 378(26):2475-85. 
7.  Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2021 update). 2021 www.ginasthma.org. Accessed April 15, 2022. 
8.  Peters AT, Spector S, Hsu J, et al. Diagnosis and management of rhinosinusitis: a practice parameter update. Ann Allergy Asthma Immunol. 2014;113(4):347-85. 
9.  Orlandi RR, Kingdom TT, Hwang PH, et al. International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol. 2016 Feb; Suppl 1:S22-209. 
10.  European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Consensus report of the European Task Force on atopic dermatitis. Dermatology. 1993; 186:23-31. 
11.  Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet 2017; 389(10086)(suppl):2287-2303. 
12.  Oranje AP. Practical issues on interpretation of scoring atopic dermatitis: SCORAD index, objective SCORAD, patient-oriented SCORAD and three-item severity score. Curr Probl Dermatol. 2011; 41:149-55. 
13.  Gonsalves NP, Aceves SS. Diagnosis and treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2020;145(1):1-7. 
14.  Hirano I, Chan ES, Rank MA, et al. AGA Institute and the Joint Task Force on allergy-immunology practice parameters clinical guidelines for the management of eosinophilic esophagitis. Gastroenterology. 2020;158:1776-86. 
15.  Dellon ES, Khoury P, Muir AB, et al. A clinical severity index for eosinophilic esophagitis: development, consensus, and future directions. Gastroenterology. 2022;1-18 [Epub ahead of print]

16.Williams KA, Huang AH, Belzberg M, et al. Prurigo nodularis: pathogenesis and management. J Am Acad Dermatol. 2020;83(6):1567-75. 
17. Leis M, Fleming P, Lynde CW. Prurigo nodularis: review and emerging treatments. Skin Therapy Lett. 2021;26(3):5-8.

Last review date: June 1, 2023