CurrentCignaPolicy N/A

Topical Acne - Winlevi Prior Authorization Policy

Defines prior authorization requirements for coverage of Winlevi (clascoterone 1% cream) for treatment of acne vulgaris in Cigna-administered health benefit plans; applies to prescribers and patients seeking prescription benefit coverage.

Policy Summary

PayerCigna

PolicyTopical Acne - Winlevi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified criterion

Effective DateN/A

Next Review DateFeb 28, 2024

Key ActionObtain prior authorization and document patient age (≥12), prior use of ≥1 prescription topical retinoid, and prior use of ≥3 prescription non‑retinoid topical therapies.

SourceLink

POLICY UPDATE CHANGES

The criterion requiring 'Patient has tried three other prescription topical therapies' was clarified to specify these must be non-retinoid topical therapies and that topical retinoids do not count.

≥12min age

1 yrapproval duration

≥1prior retinoid

≥3prior non‑retinoid

Coverage Criteria for Winlevi (clascoterone 1% cream)

Winlevi (clascoterone 1% cream) is considered experimental, investigational, or unproven for any use(s) other than treatment of acne vulgaris.

Product Coding and Age Limit

Covered productNDC | mixedCovered

clascoterone 1% cream

Winlevi (ingredient/HCPCS not specified in document)

Minimum age

Minimum patient age>= 12 years

Approval duration when criteria metApprove for 1 year

Authorization requirementPatient must meet all coverage criteria (age, prior retinoid, prior non-retinoid topicals)

Prior Authorization & Documentation Requirements

Policy Summary

PayerCigna

PolicyTopical Acne - Winlevi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified criterion

Effective DateN/A

Next Review DateFeb 28, 2024

Key ActionObtain prior authorization and document patient age (≥12), prior use of ≥1 prescription topical retinoid, and prior use of ≥3 prescription non‑retinoid topical therapies.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Prior Authorization

Prior Authorization Required

Prior authorization required. Approvals may be granted for up to 1 year when criteria are met.

Applies to Winlevi (clascoterone 1% cream)

Step Therapy

Step Therapy / Previous Therapy Requirements

Patient must meet step therapy / previous therapy requirements before approval.

Patient has tried ≥1 prescription topical retinoid.
Patient has tried ≥3 prescription non‑retinoid topical therapies (topical retinoids do NOT count toward this non‑retinoid requirement).
Examples of prescription topical retinoids: adapalene (Differin, generic), trifarotene (Aklief 0.005% cream), tazarotene (Tazorac 0.1% cream/gel), tretinoin.
Examples of prescription non‑retinoid topical therapies: dapsone gel (Aczone, generic), azelaic acid 20% cream (Azelex), topical clindamycin, topical erythromycin, topical minocycline (Amzeeq 4% foam).

Documentation Required

Required Documentation for Prior Authorization

Required documentation must be submitted with the prior authorization request.

Patient age (must be ≥ 12 years for FDA‑approved acne indication).
Documentation of having tried at least one prescription topical retinoid (name and dates).
Documentation of having tried at least three prescription non‑retinoid topical therapies (names and dates).
Clinical diagnosis supporting use for acne vulgaris.
Any additional supporting clinical notes or prior therapy responses.
Duration requested (approvals may be issued up to 1 year when criteria are met).

Denial Risk

Non‑FDA or Unproven Uses

Requests for indications other than acne vulgaris are considered experimental, investigational, or unproven and may be denied.

Use limited to FDA‑approved indication: acne vulgaris.

Definitions

Acne vulgaris and related therapies

Definition — Acne vulgarisCommon inflammatory skin condition treated with topical therapies; Winlevi (clascoterone 1% cream) is indicated for topical treatment of acne vulgaris in patients >= 12 years of age.

Mechanism / productWinlevi is an androgen receptor inhibitor (clascoterone 1% cream).

Related topical therapies — prescription retinoids (examples)Adapalene (Differin, generic), trifarotene 0.005% (Aklief), tazarotene 0.1% cream/gel, tretinoin

Related topical therapies — non‑retinoid examplesDapsone gel (Aczone), azelaic acid 20% (Azelex), topical clindamycin, topical erythromycin, topical minocycline (Amzeeq)

Safety noteWinlevi carries a warning for potential HPA axis suppression, especially with large surface area or prolonged use; pediatric patients may be more susceptible.

OpenPayer

Topical Acne - Winlevi Prior Authorization Policy

Coverage Criteria for Winlevi (clascoterone 1% cream)

Product Coding and Age Limit

Prior Authorization & Documentation Requirements

Background on Winlevi (clascoterone 1% cream)

Definitions