WINLEVI (clascoterone)

SELF ADMINISTRATION - TOPICAL

Diagnosis considered for coverage:
  • Indicated for the topical treatment of acne vulgaris in patients 12 years of age and older
Coverage Criteria:

For diagnosis of acne vulgaris:

  • Quantity requested does not exceed 60 grams per 30 day supply or 180 grams per 90 day supply, AND
  • Patient is 12 years of age or older, AND
  • Patient has a diagnosis of acne vulgaris as confirmed by chart note documentation, AND
  • Prescribed by or in consultation with a dermatologist, AND
  • Patient has tried and failed 3 of the following (for a minimum of a 30-day supply) within the past 180 days:
    • Generic single-agent topical clindamycin product
    • Generic topical tretinoin
    • Generic tazarotene cream
    • Generic dapsone gel
Reauthorization Criteria:

For diagnosis of acne vulgaris:

  • Quantity requested does not exceed 60 grams per 30 day supply or 180 grams per 90 day supply, AND
  • Patient had a positive clinical response to therapy as confirmed by chart note documentation
Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • Recommended dose: Apply to the affected area twice per day
  • Warnings for local skin reactions and hypothalamic-pituitary-adrenal (HPA) axis suppression
Policy Updates:
  • 06/15/2021 – New policy approved by P&T
References:
  • Winlevi Prescribing Information. Cassiopea, Inc. Milan, Italy. August 2020.
  • FDA Multi-Discipline Review. Available online at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213433Orig1s000MultidisciplineR.pdf. Accessed January 4, 2021.

Last review date: June 15, 2021

Rite Aid Pharmacy Patients: All Rite Aid pharmacies nationwide are closing! Please be on the lookout for information from Rite Aid pharmacies about their bankruptcy and store closures. Call your Rite Aid pharmacy for questions about your prescriptions and new pharmacy options. WHA is here to help as well. Contact Us via Phone