Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Dupixent 1690-A SGM P2023
Drug
DUPIXENT (dupilumab)
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications A. Dupixent is indicated for the treatment of 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. B. Dupixent is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 6 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. C. Dupixent is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). D. Dupixent is indicated for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE). E. Dupixent is indicated for the treatment of adult patients with prurigo nodularis (PN).
Limitation of Use: Dupixent is not indicated for the relief of acute bronchospasm or status asthmaticus
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: A. Atopic dermatitis 1. For initial requests: i. Member’s chart notes or medical records showing affected area(s) and body surface area (where applicable). ii. Member’s chart notes, medical record documentation, or claims history of prerequisite therapies including response to therapy. If prerequisite therapies are not advisable, documentation of why therapies are not advisable for the member. 2. For continuation requests: Documentation (e.g., chart notes) that the member has experienced a positive clinical response to therapy as evidenced by low disease activity or improvement in signs or symptoms of atopic dermatitis.
B. Asthma 1. For initial requests: i. Member’s chart or medical record showing pretreatment blood eosinophil count (where applicable). ii. Chart notes, medical record documentation, or claims history supporting previous medications triedincluding drug, dose, frequency, and duration. 2. For continuation requests: Chart notes or medical record documentation supporting improvement in asthma control.
C. Chronic rhinosinusitis with nasal polyposis 1. For initial requests: i. Member’s chart or medical record showing nasal endoscopy, anterior rhinoscopy, or computed tomography (CT) details (e.g., location, size), or Meltzer Clinical Score or endoscopic nasal polyp score (NPS) (where applicable). ii. Chart notes, medical record documentation, or claims history supporting previous medications tried. If therapy is not advisable, documentation of clinical reason to avoid therapy. 2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.
D. Eosinophilic esophagitis 1. For initial requests: i. Member’s chart or medical record showing endoscopic biopsy details including intraepithelial esophageal eosinophil count. ii. Chart notes, medical record documentation, or claims history supporting previous medications tried. If therapy is not advisable, documentation of clinical reason to avoid therapy. 2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.
E. Prurigo Nodularis 1. For initial requests: i. Member’s chart or medical record of symptoms (e.g., pruritus, nodular lesions). ii. Member’s chart, medical record, or claims history of prerequisite therapies including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy. 2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with one of the following: A. Atopic dermatitis: dermatologist or allergist/immunologist B. Asthma: allergist/immunologist or pulmonologist C. Chronic rhinosinusitis with nasal polyposis: allergist/immunologist or otolaryngologist D. Eosinophilic esophagitis: gastroenterologist or allergist/immunologist E. Prurigo nodularis: dermatologist or allergist/immunologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Atopic dermatitis Authorization of 4 months may be granted for treatment of moderate-to-severe atopic dermatitis in members 6 months of age or older when all of the following criteria are met: 1. Affected body surface is greater than or equal to 10% body surface area OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected. 2. Member meets one of the following: i. Member has had an inadequate treatment response with one of the following in the past year: a. A medium potency to super-high potency topical corticosteroid (see Appendix A) b. A topical calcineurin inhibitorii. The use of medium potency to super-high potency topical corticosteroid and topical calcineurin inhibitor are not advisable for the member (e.g., due to contraindications, prior intolerances, potency not appropriate for member’s age).
B. Asthma Authorization of 6 months may be granted for treatment of asthma in members 6 years of age or older when all of the following criteria are met: 1. Member as uncontrolled asthma as demonstrated by experiencing at least one of the following within the past year: i. Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment. ii. One or more asthma exacerbation resulting in hospitalization or emergency medical care visit. iii. Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma). 2. Member meets one of the following criteria: i. Member has a baseline blood eosinophil count of at least 150 cells per microliter and inadequate asthma control despite current treatment with both of the following medications at optimized doses: a. Medium-to-high-dose inhaled corticosteroid b. Additional controller (i.e., long acting beta2- agonist, long acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline) ii. Member has inadequate asthma control despite current treatment with all of the following medications at optimized doses*: a. High-dose inhaled corticosteroid b. Additional controller (i.e., long acting beta2- agonist, long acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline) c. Oral glucocorticoids (at least 5 mg per day of prednisone/prednisolone or equivalent)*Members should be receiving treatment with inhaled corticosteroid and additional controller for at least the previous 3 months, and oral glucocorticoids for most days during the previous 6 months (e.g. 50% of days, 3 steroid bursts in the previous 6 months).6 3. Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional controller) in combination with Dupixent.
C. Chronic rhinosinusitis with nasal polyposis (CRSwNP) Authorization of 6 months may be granted for treatment of CRSwNP in members 18 years of age or older when all of the following criteria are met: 1. Member has bilateral nasal polyposis and chronic symptoms of sinusitis despite intranasal corticosteroid treatment for at least 2 months unless contraindicated or not tolerated; and 2. The member has CRSwNP despite one of the following: i. Prior sino-nasal surgery; or ii. Prior treatment with systemic corticosteroids within the last two years was ineffective, unless contraindicated or not tolerated; and 3. Member has one of the following: i. A bilateral nasal endoscopy, anterior rhinoscopy, or computed tomography (CT) showing polyps reaching below the lower border of the middle turbinate or beyond in each nostril ii. Meltzer Clinical Score of 2 or higher in both nostrils iii. A total endoscopic nasal polyp score (NPS) of at least 5 with a minimum score of 2 for each nostril 4. Member has nasal blockage plus one additional symptom: i. Rhinorrhea (anterior/posterior); or ii. Reduction or loss of smell; oriii. Facial pain or pressure 5. Member will continue to use a daily intranasal corticosteroid while being treated with Dupixent, unless contraindicated or not tolerated.
D. Eosinophilic esophagitis (EoE) Authorization of 6 months may be granted for treatment of EoE in members 12 years of age or older, weighing at least 40 kg, when all of the following criteria are met: 1. Member has history of an average of at least 2 episodes of dysphagia (with intake of solids) per week. 2. Diagnosis has been confirmed by esophageal biopsy as characterized by 15 or more intraepithelial esophageal eosinophils per high power field. 3. Member has had an inadequate treatment response to both of the following: i. Proton pump inhibitor ii. Systemic corticosteroid or local therapies (e.g., budesonide, fluticasone [powder or suspension for inhalation] swallowed), unless contraindicated or not tolerated.
E. Prurigo Nodularis Authorization of 6 months may be granted for treatment of prurigo nodularis in members 18 years of age or older when all of the following criteria are met: 1. Member must have pruritus lasting at least 6 weeks. 2. Member has history or signs of repeated itch-scratch cycle (e.g., scratching, picking, or rubbing). 3. Member must have a minimum of 20 nodular lesions. 4. Member meets one of the following: i. Member has had an inadequate response to one of the following: a. A medium to super-high potency topical corticosteroid (see Appendix A) b. A topical calcineurin inhibitor c. Phototherapy (e.g., UVB, PUVA) d. Pharmacologic treatment with methotrexate or cyclosporine ii. Member has had an intolerance or a clinical reason to avoid any of the following: a. Medium to super-high potency topical corticosteroid (see Appendix A) and topical calcineurin inhibitor b. Pharmacologic treatment with methotrexate and cyclosporine (see Appendix B)
V. CONTINUATION OF THERAPY
A. Atopic dermatitis Authorization of 12 months may be granted for members 6 months of age or older (including new members) who are using the requested medication for moderate-to-severe atopic dermatitis when the member has achieved or maintained a positive clinical response as evidenced by low disease activity (i.e., clear or almost clear skin), or improvement in signs and symptoms of atopic dermatitis (e.g., redness, itching, oozing/crusting).
B. Asthma Authorization of 12 months may be granted for continuation of treatment of asthma in members 6 years of age or older when all of the following criteria are met: 1. Asthma control has improved on Dupixent treatment as demonstrated by at least one of the following: i. A reduction in the frequency and/or severity of symptoms and exacerbations ii. A reduction in the daily maintenance oral corticosteroid dose 2. Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional controller) in combination with Dupixent.
C. Chronic rhinosinusitis with nasal polyposis (CRSwNP) Authorization of 12 months may be granted for continuation of treatment of chronic rhinosinusitis with nasal polyposis when all of the following are met: 1. Member is 18 years of age or older. 2. Member has achieved or maintained positive clinical response to Dupixent therapy as evidenced by improvement in signs and symptoms of CRSwNP (e.g., improvement in nasal congestion, nasal polyp size, loss of smell, anterior or posterior rhinorrhea, sinonasal inflammation, hyposmia and/or facial pressure or pain or reduction in corticosteroid use).
D. Eosinophilic Esophagitis Authorization of 12 months may be granted for continuation of treatment of eosinophilic esophagitis in members 12 years of age or older, weighing at least 40 kg, when member has achieved or maintained a positive clinical response with Dupixent therapy as evidenced by improvement in signs and symptoms of eosinophilic esophagitis (e.g., dysphagia, heartburn, chest pain, emesis).
E. Prurigo Nodularis Authorization of 12 months may be granted for members 18 years of age or older (including new members) who are using the requested medication for prurigo nodularis when the member has achieved or maintained a positive clinical response as evidenced by one of the following: 1. Low disease activity (i.e., clear or almost clear skin). 2. Reduction in pruritis intensity and improvement in extent and severity of nodular lesions.
VI. OTHER
For all indications: Member cannot use Dupixent concomitantly with any other biologic drug or targeted synthetic drug.
Note: If the member is a current smoker or vaper, they should be counseled on the harmful effects of smoking and vaping on pulmonary conditions and available smoking and vaping cessation options.
VII. APPENDICES
Appendix A: Table. Relative potency of select topical corticosteroid products
Hydrocortisone (base, greater than or equal to 2%)
Cream, Ointment, Solution
2.5%
Lotion
2%
Hydrocortisone (base, less than 2%)
Cream, Ointment, Gel, Lotion, Spray, Solution
1%
Cream, Ointment
0.5%
Hydrocortisone acetate
Cream
2.5%
Lotion
2%
Cream
1%
Appendix B: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate or Cyclosporine 1. Clinical diagnosis of alcohol use disorder, alcoholic liver disease or other chronic liver disease 2. Drug interaction 3. Risk of treatment-related toxicity 4. Pregnancy or currently planning pregnancy 5. Breastfeeding 6. Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension) 7. Hypersensitivity 8. History of intolerance or adverse event
Place of Service:
Outpatient
The above policy is based on the following references:
Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; October 2022.
Eichenfield LF, Tom WL, 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;71:116-132.
Simpson EL., Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375:2335-2348.
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):2486-2496.
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):2475-2485.
Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2021 update. Available at: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Accessed March 11, 2022.
Topical Corticosteroids. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; December 1, 2021. Accessed November 7, 2022.
gov. National Library of Medicine (US). Identifier NCT02912468, A Controlled Clinical Study of Dupilumab in Patients with Nasal Polyps (SINUS-24) 2016 Sep 23. Available from: https://clinicaltrials.gov/ct2/show/NCT02912468.
gov. National Library of Medicine (US). Identifier NCT02898454, A Controlled Clinical Study of Dupilumab in Patients with Nasal Polyps (SINUS-52) 2016 Sep 13. Available from: https://clinicaltrials.gov/ct2/show/NCT02898454.
Fishbein AB, Silverberg, JI, Wilson EJ, et al. Update on atopic dermatitis: Diagnosis, severity assessment, and treatment selection. J Allergy Clin Immunol Pract. 2020;8(1): 91-101.
Cloutier MM, Dixon AE, Krishnan JA, et al. Managing asthma in adolescents and adults: 2020 asthma guideline update from the National Asthma Education and Prevention Program. 2020;324(22): 2301-2317.
Bachert C, Han JK, Wagenmann M, et al, EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29-36.
Lucendo AJ, Molina-Infante J, Arias A, et al. Guidelines on eosinophilic esophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J. 2017;5(3):355-358.
Gonsalves NP, Aceves S. Diagnosis and treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2020;145(1):1-7.
gov. National Library of Medicine (US). Identifier NCT03633617. Study to determine the efficacy and safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) 2022 May 27. Available from: https://clinicaltrials.gov/ct2/show/NCT03633617.
gov. National Library of Medicine (US). Identifier NCT03346434, Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 months to <6 years with Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL) 2022 Jun 10. Available from: https://clinicaltrials.gov/ct2/show/NCT03346434.
WJ Fokkens, VJ Lund, C Hopkins, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. 2020;58(Suppl S29):1-464.
Hopkins C. Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2019;381(1):55-63.
gov. National Library of Medicine (US). Identifier NCT04183335. Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME). February 17, 2022. Available from: https://clinicaltrials.gov/ct2/show/NCT04183335.
gov. National Library of Medicine (US). Identifier NCT04202679. Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2). September 28, 2022. Available from: https://clinicaltrials.gov/ct2/show/NCT04202679.
Ständer HF, Elmariah S, Zeidler C, et al. Diagnostic and treatment algorithm for chronic nodular prurigo. J Am Acad Dermatol. 2020;82(2):460-468.
Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84(3):747-760.
Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; October 4, 2022. Accessed October 12, 2022.
Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; October 4, 2022. Accessed October 12, 2022.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
