Pharmacy Prior Authorization Criteria

Winlevi (clascoterone) cream

Indications for Prior Authorization

Winlevi (clascoterone) cream

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

Criteria

Winlevi

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of acne vulgaris (i.e., acne)
AND
• Patient is 12 years of age or older [a]
AND
• Trial and inadequate response (of a minimum 30-day supply) within the past 180 days, contraindication, or intolerance to one of the following:
• generic adapalene (cream, gel, lotion)
• generic topical tretinoin or tretinoin microsphere
• generic tazarotene cream
• generic single-agent topical clindamycin product
• generic dapsone gel

Winlevi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy

P & T Revisions

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

References

1. Winlevi Prescribing Information. Sun Pharmaceuticals, Inc. Cranbury, NJ. July 2022.
2. FDA Multi-Discipline Review. Available online at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213433Orig1s000MultidisciplineR.pdf. Accessed January 15, 2024.

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End Notes

1. 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]

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Revision History

• 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.

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