This program applies to Dupixent for the treatment of atopic dermatitis. For indications other than atopic dermatitis, refer to the Specialty Guideline Management program for Dupixent. Coverage will be provided if all the approval criteria are met and the member has no exclusions to the prescribed therapy.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: A. Initial requests: 1. Member’s chart notes or medical records showing affected area(s) and body surface area (where applicable). 2. Member’s chart notes or medical record documentation and claims history of prerequisite therapies (including topical calcineurin inhibitors, topical corticosteroids, or biologics/targeted synthetic drugs) including dosage, duration, and response to therapy. If prerequisite therapy is not advisable, documentation of why topical corticosteroid and/or topical calcineurin inhibitor is/are not advisable for the member. B. 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.
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a dermatologist or allergist/immunologist.
IV. CRITERIA FOR INITIAL APPROVAL
A. Authorization of 4 months may be granted for members 6 months of age or older who have previously received a biologic (e.g., Adbry) or targeted synthetic drug (e.g., Cibinqo, Rinvoq) indicated for moderate-to-severe atopic dermatitis in the past 180 days.
B. Authorization of 4 months may be granted for treatment of moderate-to-severe atopic dermatitis in members 6 months of age or older when both of the following criteria are met:1-7 1. Affected body surface area is greater than or equal to 10% body surface areaOR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected. 2. Member meets either of the following: i. Member has had an inadequate treatment response with either of the following in the past 180 days: a. A high potency or super-high potency topical corticosteroid (see Appendix) b. A topical calcineurin inhibitor ii. The use of high potency or 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).
V. CONTINUATION OF THERAPY
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 and who achieve or maintain 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).
VI. OTHER
Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
VII. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
VIII. APPENDIX
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%
Place of Service:
Outpatient
The above policy is based on the following references:
Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; October 2023.
Eichenfield LF, Tom WL, Chamlin SL, et. al. Guidelines of care for the management of atopic dermatitis: Section Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-351.
Sidbury R, Alikhan A, Bercovitch L, et. al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.
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.
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.
Wollenberg A, Christen-Zäch S, Taieb A, et al. ETFAD/EADV Eczema task force 2020 position paper on diagnosis and treatment of atopic dermatitis in adults and children. J Eur Acad Dermatol Venereol. 2020;34(12):2717-2744.
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.
Topical Corticosteroids. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; September 1, 2023. Accessed November 2, 2023.
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.
