Pharmacy Prior Authorization Criteria

Winlevi (clascoterone) cream

For diagnosis of Acne Vulgaris
Indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

AND

AND

Trial and inadequate response (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to one of the following:

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

2025-01-23, 2024-01-15, 2023-11-16, 2023-05-26, 2023-01-31, 2022-01-27, 2021-02-18

Winlevi Prescribing Information. Sun Pharmaceuticals, Inc. Cranbury, NJ. July 2022.
FDA Multi-Discipline Review. Available online at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213433Orig1s000MultidisciplineR.pdf. Accessed January 21, 2025

A subgroup analysis for subjects 9 to less than 12 years of age did not show a beneficial treatment effect, and the incidences of adverse events in this age group were higher compared to older adolescents and adults, including hypothalamic-pituitary-adrenal (HPA) suppression three-times that of the HPA suppression observed in adults. Also, this age group had a substantially higher incidence of hyperkalemia compared to other age groups. These considerations led to the FDA approval of Winlevi in patients 12 years of age and older. [2]

2025-01-23: 2025 Annual Review. Background updates only.
2024-01-15: 2024 Annual Review. No changes to clinical criteria. Update to UM Characteristics and references.
2023-11-16: Program update to standard reauthorization language. No changes to clinical intent
2023-05-26: Formulary strategy update to revise trial requirement to single step.
2023-01-31: Annual review - updated references.
2022-01-27: Annual review - updated references.
2021-02-18: New program for Winlevi.