Halobetasol Propionate (Bryhali, Lexette, Ultravate) Form

Halobetasol propionate (Bryhali™, Lexette™, Ultravate®) is a topical corticosteroid. FDA Approved Indication(s) Bryhali, Lexette, and Ultravate are indicated for the topical treatment of plaque psoriasis (PsO). Bryhali is indicated in adults, while Lexette and Ultravate are indicated 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 Bryhali, Lexette, and Ultravate are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Plaque Psoriasis (must meet all):

1. Diagnosis of PsO;
   2. Member meets one of the following (a or b): a. For Bryhali: Age ≥ 18 years; b. For Lexette or Ultravate: Age ≥ 12 years;
2. Member must use generic topical halobetasol propionate (e.g., foam, ointment, cream), unless contraindicated or clinically significant adverse effects are experienced;
3. Failure of generic clobetasol propionate, unless contraindicated or clinically significant adverse effects are experienced;

4. Dose does not exceed one of the following (a, b, or c): a. Bryhali (i and ii):
   i. One tube per 2 weeks; ii. 100 g per 2 weeks; b. Lexette (i and ii):
   i. One canister per week;
   ii. 50 g per week; c. Ultravate: one bottle (60 mL) per week. Approval duration: 6 months Page 1 of 6

   CLINICAL POLICY Halobetasol Propionate B. Other diagnoses/indications (must meet 1 or 2):

5. 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
6. 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. Plaque Psoriasis (must meet all):
7. 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);
   2. Member is responding positively to therapy;
   3. Medical justification supports treatment beyond the recommended duration in the prescribing information of the requested product;
8. If request is for a dose increase, new dose does not exceed one of the following (a, b or c): a. Bryhali (i and ii):
   i. One tube per 2 weeks; ii. 100 g per 2 weeks; b. Lexette (i and ii):
   i. One canister per week;
   ii. 50 g per week;
   c. Ultravate: one bottle (60 mL) per week. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

9. 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 2 of 6

   CLINICAL POLICY Halobetasol Propionate 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

10. 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.
    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 and CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration PsO: plaque psoriasis 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 Dose Limit/ Maximum Dose 50 g/week 50 g/week halobetasol propionate 0.05% foam/cream/ointment (Ultravate) clobetasol propionate 0.05% cream/foam/gel/lotion/ointment/shampoo/spray (Clobex®, Olux-E®, Olux®) Apply a thin layer to the affected skin QD to BID. Treatment should be limited to 2 weeks Apply a thin layer to the affected skin BID. Treatment should be limited to 2 weeks for mild to moderate PsO and 4 weeks for moderate to severe PsO 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
    Page 3 of 6

    CLINICAL POLICY Halobetasol Propionate V. Dosage and Administration
    Drug Name Halobetasol propionate lotion 0.01% (Bryhali) Halobetasol propionate lotion 0.05% (Ultravate) or foam 0.05% (Lexette) VI. Product Availability
    Dosing Regimen Topically apply a thin layer to the affected skin QD for up to 8 weeks Topically apply a thin layer to the affected skin BID for up to 2 weeks Maximum Dose 50 g/week
    50 g/week
    Drug Name Halobetasol propionate lotion 0.01% (Bryhali) Halobetasol propionate foam 0.05% (Lexette) Halobetasol propionate lotion 0.05% (Ultravate) Availability Lotion (60 g, 100 g): 0.01% Foam (50 g, 100 g): 0.05% Lotion (60 mL): 0.05% VII.