Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Cibinqo SGM 5142-A P2025
Drug
CIBINQO(abrocitinib)
Policy:
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 Indications1
Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
All other indications are considered experimental/investigational and not medically necessary.
Documentation
Submission of the following information is necessary to initiate the prior authorization review:
Initial requests
Chart notes or medical record documentation showing affected area(s) and affected body surface area (where applicable).
Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy (where applicable).
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Prescriber Specialties
This medication must be prescribed by or in consultation with a dermatologist or allergist/immunologist.
Coverage Criteria
Atopic Dermatitis1-4,7
Authorization of 4 months may be granted for members 12 years of age or older for treatment of moderate-to-severe atopic dermatitis when the member has had an inadequate response or intolerance to at least one biologic (e.g., Adbry, Dupixent, Ebglyss, Nemluvio) or a systemic targeted synthetic drug (e.g., Rinvoq) in the past year.
Authorization of 4 months may be granted for treatment of moderate-to-severe atopic dermatitis in members 12 years of age or older when all of the following criteria are met:
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.
Member meets either of the following:
Member has had an inadequate treatment response with one of the following in the past year:
A medium potency to super-high potency topical corticosteroid (see Appendix)
A topical calcineurin inhibitor
A topical Janus kinase (JAK) inhibitor
A topical phosphodiesterase-4 (PDE-4) inhibitor
The use of medium potency to super-high potency topical corticosteroid, topical calcineurin inhibitor, topical JAK inhibitor, and topical PDE-4 inhibitor are not advisable for the member (e.g., due to contraindications, prior intolerances).
Member has had an inadequate response or intolerance to treatment with a biologic (e.g., Adbry, Dupixent, Ebglyss, Nemluvio) or systemic targeted synthetic drug (e.g., Rinvoq) indicated for the treatment of atopic dermatitis.
Continuation of Therapy1,3
Authorization of 12 months may be granted for members 12 years 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).
Other1,5
Member has had a documented negative tuberculosis (TB) test (which can include a tuberculosis skin test [TST] or an interferon-release assay [IGRA]) within 12 months of initiating therapy for persons who are naïve to biologic drugs or targeted synthetic drugs associated with an increased risk of TB.
If the screening testing for TB is positive, there must be further testing to confirm there is no active disease (e.g., chest x-ray). Do not administer the requested medication to members with active TB infection. If there is latent disease, TB treatment must be started before initiation of the requested medication.
Member cannot use the requested medication concomitantly with any other biologic drug, targeted synthetic drug, or potent immunosuppressant such as azathioprine or cyclosporine.
Appendix
Table. Relative Potency of Select Topical Corticosteroid Products6
Hydrocortisone (base, greater than or equal to 2%)
Cream, Ointment, Solution
2.5%
VII. Least potent (group 7)
Hydrocortisone (base, greater than or equal to 2%)
Lotion
2%
VII. Least potent (group 7)
Hydrocortisone (base, less than 2%)
Cream, Ointment, Gel, Lotion, Spray, Solution
1%
VII. Least potent (group 7)
Hydrocortisone (base, less than 2%)
Cream, Ointment
0.5%
VII. Least potent (group 7)
Hydrocortisone acetate
Cream
2.5%
VII. Least potent (group 7)
Hydrocortisone acetate
Lotion
2%
VII. Least potent (group 7)
Hydrocortisone acetate
Cream
1%
Place of Service:
Outpatient
The above policy is based on the following references:
Cibinqo [package insert]. New York, NY: Pfizer Inc.; December 2023.
Simpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 clinical trial. Lancet. 2020;396:255-266.
Eichenfield LF, Tom WL, Chamlin SL, et. al. Guidelines of care for the management of atopic dermatitis: Section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-51.
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.
Topical Corticosteroids. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; July 18, 2024. Accessed November 9, 2024.
Davis DMR, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. J Am Acad Dermatol. 2024 Feb;90(2):e43-e56.
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.
