Winlevi (clascoterone) — Blue Cross Blue Shield of Alabama

acne vulgaris

Initial criteria

Winlevi (clascoterone) will be approved when ONE of the following is met:
The requested agent is eligible for continuation of therapy AND ONE of the following:
• The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
• The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
BOTH of the following:
• The patient has a diagnosis of acne vulgaris AND ONE of the following:
– The patient has tried and had an inadequate response to at least ONE generic topical antibiotic agent used in the treatment of acne OR
– The patient has tried and had an inadequate response to at least ONE generic topical retinoid agent used in the treatment of acne OR
– The patient has an intolerance or hypersensitivity to a generic topical antibiotic agent OR a generic topical retinoid therapy used in the treatment of acne OR
– The patient has an FDA labeled contraindication to ALL generic topical antibiotic agents AND generic topical retinoid agents used in the treatment of acne AND
If the patient has an FDA labeled indication, then ONE of the following:
• The patient’s age is within FDA labeling for the requested indication for the requested agent OR
• There is support for using the requested agent for the patient’s age for the requested indication

The requested agent is eligible for continuation of therapy as described in the initial criteria.

12 months