Clascoterone (Winlevi) Form

Clascoterone (Winlevi®) is an androgen receptor inhibitor. FDA Approved Indication(s) Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Winlevi is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acne Vulgaris (must meet all):

1. Diagnosis of acne vulgaris;
2. Age ≥ 12 years;
3. Failure of ≥ 2 of the following generic formulary topical preparations, each from different medication classes, each used for ≥ 2 months, unless clinically significant adverse effects are experienced or all are contraindicated: a. Topical antibiotics: clindamycin, erythromycin; b. Topical anti-infectives: benzoyl peroxide; c. Topical retinoids: tretinoin, tazarotene, adapalene; Prior authorization may be required for tretinoin

4. Dose does not exceed 60 grams (1 tube) per month. Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less
   B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: Page 1 of 5

   CLINICAL POLICY Clascoterone CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Acne Vulgaris (must meet all):
   3. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
5. Member is responding positively to therapy;

6. If request is for a dose increase, new dose does not exceed 60 grams (1 tube) per month. Approval duration:
   Medicaid/HIM – 12 months Commercial –12 months or duration of request, whichever is less
   B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. Page 2 of 5

   CLINICAL POLICY Clascoterone III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen clindamycin (Cleocin T®) erythromycin (Erygel®, Ery®) benzoyl peroxide (Benzac®, BPO®, Brevoxyl®, PanOxyl®) tretinoin (Retin-A®) tazarotene (Tazorac®) adapalene (Differin®) Apply a thin film BID Apply a thin film BID Apply or wash 1 to 3 times daily Apply a thin layer to the affected area(s) once daily at bedtime Apply a thin layer to the affected area(s) once daily at bedtime Apply a thin layer to the affected area(s) once daily at bedtime Dose Limit/ Maximum Dose BID BID TID Various
   Various
   Various Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings None reported
   V. Dosage and Administration
   Indication Acne vulgaris Dosing Regimen Apply approximately 1 gram topically to the affected area twice daily Maximum Dose 2 gm/day VI. Product Availability
   Cream: 1% (60 g tube) VII.