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ph-91201

Winlevi (clascoterone) Step Therapy Program Summary

Policy Number: PH-91201

This program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
01-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Winlevi® (clascoterone) Cream	Topical treatment of acne vulgaris in patients 12 years of age and older		1

Agent(s)

FDA Indication(s)

Notes

Ref#

Winlevi®

(clascoterone)

Cream

Topical treatment of acne vulgaris in patients 12 years of age and older

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Acne Vulgaris

Acne vulgaris is a common, chronic, inflammatory skin disorder of the pilosebaceous unit. Signs and symptoms include comedones, papules, pustules, or nodules on the face, but may also affect the upper arms, trunk, and back. Acne vulgaris most commonly occurs in adolescents, but it can affect most age groups and can persist into adulthood.(2,3) Topical therapies are the mainstay of acne treatment, and are used alone or in combination with other topical or oral agents. Using a combination of multiple mechanisms of action of topical therapies is recommended as multimodal therapy to optimize efficacy and reduce the risk of antibiotic resistance. Systemic oral antibiotics are typically used to treat moderate to severe acne. (2)

Topical retinoids are vitamin A derivatives and are strongly recommended for the treatment of acne by the American Academy of Dermatology (AAD). Topical retinoid agents include tretinoin, adapalene, tazarotene, and trifarotene. Only modest differences in activity, tolerability, and efficacy have been noted between the different retinoids, and comparative effectiveness data does not suggest superiority of one topical retinoid against another.(2)

BP is strongly recommended by the AAD for the treatment of acne. BP is a topical antimicrobial agent and is available over-the-counter. BP use is limited by concentration and formulation dependent side effects, including burning, stinging, dryness, erythema, and irritation. (2)

Topical antibiotics are strongly recommended by the AAD for the treatment of acne and have both antibacterial and anti-inflammatory effects. Treatment options include erythromycin, clindamycin, minocycline, and dapsone. Topical antibiotic monotherapy is not recommended due to the risk of antibiotic resistance, and they should be used in combination with BP and/or a topical retinoid. There is a lack of evidence to suggest superiority of one topical antibiotic against another.(2)

Fixed dose combination products of topical antibiotics, topical retinoids, and/or BP are strongly recommended by the AAD. Fixed dose combination products assist in treatment regimen adherence and may be less expensive than their individual components separately. When using a combination topical retinoid/antibiotic agent, it is recommended to use concomitant BP to prevent antibiotic resistance. Insufficient evidence is available to recommend topical BP, retinoids, antibiotics, or their combinations over one another.(2)

Clascoterone (Winlevi) is a topical antiandrogen agent. It is conditionally recommended for the treatment of acne by the AAD due to treatment access and cost, despite a high certainty of benefits over risks. Azelaic acid is a topical comedolytic, antibacterial, and anti-inflammatory agent and is also conditionally recommended for the treatment of acne by the AAD. Azelaic acid may be beneficial for patients with sensitive skin or dyspigmentation due to its lightening effects. Insufficient evidence is available to develop a recommendation on the use of topical sodium sulfacetamide for acne even though it is used in practice.(2)

Safety

Winlevi has no FDA labeled contraindications for use.(1)

REFERENCES

Number	Reference
1	Winlevi prescribing information. Sun Pharmaceutical Industries, Inc. July 2022.
2	Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. Journal of the American Academy of Dermatology. 2024;90(5):1006.e1-1006.e30. doi:10.1016/j.jaad.2023.12.017
3	Sutaria AH, Masood S, Saleh HM, Schlessinger J. Acne vulgaris. StatPearls - NCBI Bookshelf. Published August 17, 2023. https://www.ncbi.nlm.nih.gov/books/NBK459173/

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

Winlevi	clascoterone cream	1 %	M ; N ; O ; Y	N

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Winlevi	clascoterone cream	1 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Winlevi (clascoterone) will be approved when ONE of the following is met:

The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
BOTH of the following:
1. The patient has a diagnosis of acne vulgaris AND ONE of the following:
  1. The patient has tried and had an inadequate response to at least ONE generic topical antibiotic agent used in the treatment of acne OR
  2. The patient has tried and had an inadequate response to at least ONE generic topical retinoid agent used in the treatment of acne OR
  3. The patient has an intolerance or hypersensitivity to a generic topical antibiotic agent OR a generic topical retinoid therapy used in the treatment of acne OR
  4. The patient has an FDA labeled contraindication to ALL generic topical antibiotic agents AND generic topical retinoid agents used in the treatment of acne AND
2. If the patient has an FDA labeled indication, then ONE of the following:
  1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
  2. There is support for using the requested agent for the patient’s age for the requested indication

Length of Approval: 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

Commercial _ PS _ Winlevi_clascoterone__PA _ProgSum_ 01-01-2025