Subject: Winlevi PA 4265-A P08-2025

Drug

WINLEVI  (clascoterone)

Policy:

Indications

FDA-approved Indications

Winlevi (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Coverage Criteria

Acne Vulgaris

Authorization may be granted when the requested drug is being prescribed for the topical treatment of acne vulgaris.

Continuation of Therapy

Acne Vulgaris

Authorization may be granted when the requested drug is being prescribed for the topical treatment of acne vulgaris when the following criteria is met:

• The patient has achieved or maintained a positive clinical response as evidenced by improvement (e.g., reduction in number of lesions, patient satisfaction, etc.).

Duration of Approval (DOA)

• 4265-A: Initial therapy DOA: 4 months; Continuation of therapy DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Winlevi (clascoterone) cream [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; July 2022.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed July 1, 2025.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 07/01/2025).
4. Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024;90(5):1006.e1-1006.e30.
5. Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156(6):621.

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.

December 12, 2025