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Winlevi (clascoterone 1% cream) — Topical Acne
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Defines Cigna's coverage and prior authorization requirements for Winlevi (clascoterone 1% cream) for treatment of acne vulgaris in insured members, including medical necessity criteria and approval duration.
Added notes under the criteria for trials with topical retinoids and topical non‑retinoids with examples of products to satisfy criteria.
Updated the requirement for previous trials of prescription medications to add 'for the treatment of acne vulgaris' throughout the policy.
For combination topical products, each active chemical entity counts as one trial (e.g., a product with 2 non-retinoids counts as 2 trials).
Removed documentation language from criteria and removed reauthorization criteria.
Coverage Criteria for Winlevi (clascoterone 1% cream)
FDA-Approved Indication (Acne Vulgaris)
Approve for 1 year if the patient meets the following (A, B, and C):
Examples of topical retinoids include adapalene, trifarotene, tazarotene, tretinoin. Examples of non-retinoid topicals include benzoyl peroxide, dapsone gel, azelaic acid 20% cream, topical clindamycin, topical erythromycin, topical minocycline (Amzeeq). Topical retinoids do not count toward non-retinoid trials. For combination products, each active chemical entity counts as one trial. Receipt of sample product does not satisfy trial requirements.
Initial Therapy
Approve for 1 year if ALL of the following are met:
Topical retinoids do not count toward non-retinoid trials. Combination products: each active chemical entity counts as one trial. Receipt of sample product does not satisfy criteria.
Reimbursement will not be provided for services billed for conditions or diagnoses that are outside the scope of this Coverage Policy. Claims submitted without covered diagnosis or procedure codes that align with the policy requirements will be denied as not covered; when billing, providers must use the most appropriate codes as of the date of submission.
Use of Winlevi (clascoterone 1% cream) for any indication other than acne vulgaris is considered not medically necessary and will be denied.
The policy explicitly designates treatment with Winlevi for indications other than acne vulgaris as not medically necessary. Criteria and coverage determinations for other indications will be revised if new published data become available.
Coding and Billing Guidance
| No codes listed |
Provider Actions, Prior Authorization, and Documentation
Prior Authorization required
Prior Authorization is required for benefit coverage of Winlevi; approvals are provided when the FDA‑approved indication criteria are met. When criteria are satisfied, approve for 1 year.
Prior authorization and 1‑year approval when criteria met
Prior authorization must be obtained; when the member is ≥ 12 years old and the required prior therapy trials are documented (≥1 prescription topical retinoid and ≥3 prescription non‑retinoid topical therapies for acne vulgaris), approval is provided for 1 year.
Prior trial requirements for coverage
Coverage requires documentation of prior trials before approval: at least one prescription topical retinoid and at least three other prescription non‑retinoid topical therapies specifically for the treatment of acne vulgaris.
- Topical retinoids do not count toward the non‑retinoid trials.
- Combination topical products count each active chemical entity as one trial.
- Receipt of sample product does not satisfy trial requirements.
Step therapy: required prior topical therapies
Step therapy is enforced: prior trials must include at least one prescription topical retinoid plus at least three prescription non‑retinoid topical therapies (examples provided in policy) before Winlevi is approved.
- Examples of non‑retinoid topicals: benzoyl peroxide, dapsone gel (Aczone), azelaic acid 20% cream, topical clindamycin, topical erythromycin, topical minocycline (Amzeeq).
- Examples of topical retinoids: adapalene (Differin), trifarotene (Aklief), tazarotene formulations, tretinoin.
Prior Authorization — documentation may be requested
Prior Authorization is required for Winlevi; medical directors may request supporting clinical documentation to demonstrate medical necessity and that the coverage criteria are met.
- Use the most appropriate diagnosis and procedure codes when billing.
- Include clinical information demonstrating trials of the required therapies with dates and products used.
Required documentation for prior therapies
Providers must document the patient's age (≥ 12 years) and prior treatment history showing at least one prescription topical retinoid trial and at least three prescription non‑retinoid topical therapy trials for acne vulgaris; samples do not satisfy trial requirements.
- Record product names, dates of use, and indication (for the treatment of acne vulgaris).
- If a combination topical product was used, document each active chemical entity to count toward required trials.
Claims without covered codes will be denied
Claims submitted without covered diagnosis or procedure codes that align with this Coverage Policy will be denied as not covered.
- When billing, use the most appropriate codes as of the date of submission.
Non‑indicated use will be denied
Requests for Winlevi for any indication other than acne vulgaris are considered not medically necessary and will be denied.
Background
Winlevi (clascoterone 1% cream) is an androgen receptor inhibitor indicated for topical treatment of acne vulgaris in patients aged 12 years and older. Clinical guidance supports topical clascoterone as part of multimodal acne management and prior authorization is required for coverage under this policy.
Definitions and Examples
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