CurrentCentenePolicy CP PMN.257

Clinical Policy: Clascoterone (Winlevi)

Defines medical necessity and prior authorization criteria for clascoterone (Winlevi) topical cream for members age 12 and older across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyClascoterone (Winlevi) topical treatment for acne vulgaris

Policy CodePolicy CP PMN.257

Change TypeClarification / Annual review

Effective Date03.01.21

Next Review Date

Key ActionSubmit prior authorization with documentation that the member meets all approval criteria, including age, diagnosis, prior topical trials, and dose limits.

SourceLink

POLICY UPDATE CHANGES

Added clarification stating authorization may be required for tretinoin in initial approval criteria.

Updated dosing for benzoyl peroxide in Appendix B of generic formulary topical preparations.

References reviewed and updated during 1Q 2025 annual review; no significant changes.

12minimum approved age

60 gmax per month

12 moapproval duration

1% / 60 gproduct strength/size

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10.22.24references last reviewed

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial approval:

Diagnosis of acne vulgaris

Age: Member is >= 12 years of age>= 12 years

Topical antibiotic trial: Trial of topical antibiotics such as clindamycin or erythromycin

Topical anti-infective trial: Trial of benzoyl peroxide

Topical retinoid trials: Failure of 2 different generic formulary topical preparations from different medication classes (examples include tretinoin, tazarotene, adapalene), each used for >= 2 months unless clinically significant adverse effects or contraindications>= 2 months for each trial

Authorization may be required for tretinoin

Dose limit: Requested dose does not exceed 60 grams per month (1 tube)<= 60 g/month

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation eligibility: Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria, or member is enrolled in a state/product with continuity of care regulations

Refer to state-specific addendums for continuity of care

Response: Member is responding positively to therapy

Dose increase: If request is for dose increase, new dose does not exceed 60 grams (1 tube) per month<= 60 g/month

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy will be handled under the payor's off‑label use procedures. Such requests must include sufficient clinical documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP CPA.09 for Commercial, HIM.PA.154 for the Health Insurance Marketplace, and CP PMN.53 for Medicaid. Absent that supporting documentation, these non‑FDA indications are not covered under this policy.

Coverage and administration of benefits for clascoterone (Winlevi) are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies. Providers should follow the member's coverage documents and any governing legal/regulatory requirements when submitting requests for coverage.

Use of clascoterone for indications that are outside the FDA‑approved labeling and for which sufficient supporting documentation per the off‑label use policies is not provided is considered not authorized and may be denied.

Coding and Quantity Limits

Maximum monthly quantity

Maximum monthly quantity60 grams (1 tube) per month; maximum 2 g/day

Per‑day maximum2 g/day

Product tube size referenced1 tube = 60 g

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Prior authorization required with documentation that member meets all approval criteria
Documentation examples: office chart notes, lab results, other clinical information

Denial Risk

Non‑FDA Indications

Requests for non‑FDA approved (off‑label) indications are not authorized by this policy unless sufficient documentation is provided demonstrating efficacy and safety consistent with the Health Plan's off‑label use policies and applicable evidence of coverage documents.

Non‑FDA indications may be denied if adequate off‑label justification is not provided

Background

Clascoterone (Winlevi) is a topical androgen receptor inhibitor approved for the treatment of acne vulgaris. This clinical policy provides medical necessity guidance to assist in coverage decisions and benefit administration; it is not a contract or medical advice. Coverage determinations are governed by the effective clinical policy together with the member's coverage documents and applicable legal and regulatory requirements.

Definitions and Dosing

Clascoterone (mechanism)

Mechanism of actionAndrogen receptor inhibitor (topical)

Therapeutic useTopical treatment for acne vulgaris

Agent exampleClascoterone (Winlevi)

Dosing regimen

Recommended regimenApply approximately 1 gram topically to affected area twice daily

Per‑day maximumMaximum 2 g/day

Application detailsApply to affected areas as directed in dosing regimen

Revision History and Policy Changes

02.24P&T approval noted

Prior P&T approval date noted in policy record; clarification that authorization may be required for tretinoin was added to initial approval criteria.

10.22.24References reviewed

References were reviewed and updated as part of the 1Q 2025 annual review; no significant clinical policy statement changes reported.

02.25P&T approval notedLatest

P&T approval date recorded during annual review cycle; administrative updates including Appendix B dosing for benzoyl peroxide were made.

Policy Summary

PayerCentene

PolicyClascoterone (Winlevi) topical treatment for acne vulgaris

Policy CodePolicy CP PMN.257

Change TypeClarification / Annual review

Effective Date03.01.21

Next Review Date

Key ActionSubmit prior authorization with documentation that the member meets all approval criteria, including age, diagnosis, prior topical trials, and dose limits.

SourceLink

On This Page

When submitting off‑label requests include peer‑reviewed literature, clinical rationale, and supporting patient‑specific documentation

Documentation Required

Coverage Documentation and Contract Compliance

Coverage decisions are subject to all terms, conditions, exclusions, and limitations of the Health Plan coverage documents and to state and federal requirements. For Medicaid members, state Medicaid coverage provisions take precedence over this clinical policy when conflicts exist.

Coverage subject to evidence of coverage, certificate of coverage, policy, contract of insurance, and applicable administrative policies
Medicaid: follow state Medicaid manual when state provisions conflict with this policy

Documentation Required

Required Coverage Documentation References

Follow applicable Health Plan coverage documents and state Medicaid provisions for required documentation and submission instructions.

Refer to the Health Plan's evidence of coverage, certificate of coverage, and provider manuals for submission requirements
For Medicaid members, consult the state Medicaid manual for coverage provisions

Step Therapy

Step Therapy / Prior Topical Trials

Step therapy/policy requires failure of prior topical treatments before approval: the member must have failed at least two different generic formulary topical preparations, each from different medication classes, each used for at least 2 months, unless clinically significant adverse effects are experienced or all are contraindicated. Examples of topical classes include topical antibiotics (clindamycin, erythromycin), topical anti‑infectives (benzoyl peroxide), and topical retinoids (tretinoin, tazarotene, adapalene).

Failure of ≥ 2 different generic formulary topical preparations
Each product must be from a different medication class
Each product trial must be for ≥ 2 months unless discontinued for adverse effects or contraindication
Topical classes: antibiotics, anti‑infectives, retinoids (see Appendix B for therapeutic alternatives)

Note

Authorization and Dose Limits

Operational note: prior authorization may be required for tretinoin depending on formulary and plan requirements. Dose limit for covered topical product does not exceed 60 grams (1 tube) per month.

Prior authorization may be required for tretinoin
Dose limit: does not exceed 60 grams (1 tube) per month

Clinical policy definition

DefinitionClinical policy: guidance document summarizing medical necessity criteria and coverage administration; not a contract or medical advice.

PurposeProvides medical necessity guidance to assist in coverage decisions and administering benefits

LimitationsDoes not constitute medical advice, a contract, or guarantee of payment

State Medicaid precedence

State Medicaid precedenceState Medicaid manual provisions supersede this policy when conflicts exist for Medicaid members.

Provider guidanceRefer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy

Coverage hierarchyState and federal requirements govern in case of discrepancies with this policy