Topical Androgen Receptor Inhibitors – Essential

Restricted Product(s)

• Winlevi (clascoterone 1% cream)

FDA Approved Use

• For the treatment of acne vulgaris in patients ≥ 12 years of age

Criteria for Approval of Restricted Product(s)

1. The patient is 12 years of age or older; AND
2. The patient has a diagnosis of acne vulgaris; AND
3. The patient has tried and failed, or has an intolerance or contraindication to ALL of the following:
   1. Benzoyl peroxide
   2. A generic topical retinoid (such as adapalene, tretinoin, tazarotene)
   3. A generic topical antibiotic (such as clindamycin, erythromycin)
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

April 2025: Criteria change: Removed requirement to try and fail spironolactone and oral contraceptive for female patients. Added requirement to try and fail a topical antibiotic.

September 2024: Criteria change: Created Essential only policy. Winlevi now unrestricted on Enhanced and Net Results.

August 2023: Criteria update: Formatting changes only.

July 2021: Criteria update: Created Enhanced and Essential only policy. Winlevi now unrestricted on Net Results. Duration of approval decreased to 365 days.

December 2020: Original utilization management criteria issued