WINLEVI (clascoterone)

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.