CurrentHealth NetPolicy CP PMN.257

Clascoterone (Winlevi)

Policy governing prior authorization and coverage criteria for Winlevi (clascoterone topical cream 1%) for treatment of acne vulgaris in patients 12 years and older across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClascoterone (Winlevi)

Policy CodePolicy CP PMN.257

Change TypeNo material change

Effective DateMar 1, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis of acne vulgaris, age ≥12, failure of ≥2 different generic topical therapies from different classes, and that monthly dose does not exceed 60 g.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum age for indication

60 gmax per month

12 moapproval duration

1% creamproduct

Coverage Criteria for Winlevi (clascoterone)

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Initial approval: 1. Diagnosis of acne vulgaris.

Age requirement: 2. Patient is ≥ 12 years of age.age >= 12

Prior topical therapy failure: 3. Failure of ≥ 2 different generic formulary topical preparations, each from different medication classes, each used for ≥ 2 months (unless clinically significant adverse effects or contraindications).failures >= 2; duration >= 2 months each

Examples of classes: topical antibiotics (clindamycin, erythromycin), topical anti-infectives (benzoyl peroxide), topical retinoids (tretinoin, tazarotene, adapalene). Prior authorization may be required for tretinoin.

Quantity limit: 4. Requested dose does not exceed 60 grams (one 60 g tube) per month.max 60 g/month

Continuation Therapy

Covered when ANY of the following are met:

Continuation - current therapy or prior approval: a. Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria.

Continuation - continuity of care: b. Member is currently receiving the medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums).

Response and dose conditions: Member is responding positively to therapy. If the request is for a dose increase, the new dose must not exceed 60 grams (one 60 g tube) per month.max 60 g/month

Approval duration as specified per line of business.

Non‑FDA approved indications for clascoterone (Winlevi) are not authorized under this policy unless the provider submits sufficient documentation demonstrating efficacy and safety consistent with the applicable Health Plan off‑label use policies. Refer to CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid when requesting coverage for an off‑label indication. Absent that supporting evidence, requests for non‑FDA uses may be denied.

Coverage and prior authorization decisions for clascoterone (Winlevi) are subject to the terms, conditions, exclusions, and limitations of the member’s benefit documents (for example, evidence of coverage, certificate of coverage, policy or contract). State and federal requirements and Health Plan administrative policies and procedures also apply. This clinical policy does not guarantee payment and does not replace provider clinical judgment; providers remain responsible for submitting requests and documentation in accordance with the member’s plan and applicable administrative requirements.

Coding, Dosing, and Quantity Limits

Affected codes (referenced)mixed

affected codes

placeholder reference in policy stating affected codes (no explicit CPT/HCPCS/ICD codes listed in these chunks)

Maximum monthly quantity

Maximum monthly quantity≤ 60 grams per month (1 tube)

Source formulation1% cream supplied as a 60 g tube

Approval constraintDose must not exceed 60 g/month for initial and continuation approvals

Daily dosing

Daily dosingApply approximately 1 gram to affected area twice daily (≈2 g/day)

Maximum daily dose2 g/day

Administration routeTopical application to affected area

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for coverage of Winlevi (clascoterone) for acne vulgaris. Providers must document that the member meets all approval criteria prior to authorization.

Diagnosis: acne vulgaris
Age: ≥ 12 years
Quantity limit: dose does not exceed 60 grams (1 tube) per month

Step Therapy

Step Therapy / Therapeutic Alternatives

Step therapy / Therapeutic Alternatives: Authorization is contingent on documented failure of appropriate topical therapies. Providers must show trials of at least two generic formulary topical preparations from different medication classes, each used for ≥ 2 months (unless discontinued for clinical reasons). Preferred alternatives are listed in Appendix B.

Failure of ≥ 2 topical therapies from different classes (each ≥ 2 months)
Examples of classes: topical antibiotics (clindamycin, erythromycin); topical anti-infectives (benzoyl peroxide); topical retinoids (tretinoin*, tazarotene, adapalene)
*Prior authorization may be required for tretinoin

Documentation Required

Required Documentation

Required Documentation: Submit office chart notes, lab results, or other clinical information demonstrating the diagnosis, age, prior medication trials (including dates, doses, and reasons for discontinuation if applicable), and that the requested dose does not exceed policy limits.

Office notes showing diagnosis of acne vulgaris and age ≥ 12 years
Documentation of trials of ≥ 2 topical generics from different classes with duration ≥ 2 months each
Documentation of dose and prescribed quantity (≤ 60 grams per month)

Note

Coverage Conditional on Benefit Documents

Coverage Conditional on Benefit Documents: Coverage decisions are subject to the member's specific benefit terms and all Health Net policies and applicable state and federal requirements. This clinical policy guides medical necessity determinations but does not guarantee payment.

Decisions subject to evidence of coverage, certificate of coverage, policy/contract terms
Non‑FDA uses are not authorized unless supported by off‑label use policies and applicable evidence of coverage

Denial Risk

Denial Triggers

Denial Triggers / Non‑Coverage: Requests lacking required documentation, seeking non‑FDA approved indications without sufficient supporting evidence, or not demonstrating required prior therapy failures or age/quantity criteria may be denied.

Non‑FDA approved indications without adequate evidence per off‑label policies (CP CPA.09, HIM.PA.154, CP PMN.53)
Missing documentation of required prior topical trials or durations
Requested dose/quantity exceeding 60 grams per month

Background and Drug Information

Clascoterone (Winlevi) is a topical androgen receptor inhibitor FDA‑approved for the treatment of acne vulgaris in patients aged ≥ 12 years. The product is supplied as a 1% cream in a 60 g tube and the recommended administration is to apply approximately 1 gram to the affected area twice daily (approximately 2 g/day maximum).

Definitions and Policy Context

Clascoterone (Winlevi) — product attributes

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

FormulationCream, 1% clascoterone

Tube size60 g tube

DosingApply approximately 1 g to affected area twice daily (max 2 g/day); do not exceed 60 g/month

Clinical policy — definition and role

DefinitionClinical policy: a document developed by experienced/licensed clinicians providing medical necessity guidance to assist coverage decisions

RoleGuides coverage decisions and administration of benefits but does not constitute a contract or guarantee of payment

ScopeBased on current standards of practice, literature, agency approvals, guidelines, and expert opinion

LimitationsNot intended to dictate clinical practice; providers retain independent medical judgment