Abametapir (Xeglyze) Form

Abametapir (Xeglyze™) is a pediculicide. FDA Approved Indication(s) Xeglyze is indicated for topical treatment of head lice infestation in patients 6 months of age and older. Xeglyze should be used in the context of an overall lice management program:
• Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towels;
• Wash personal care items such as combs, brushes and hair clips in hot water;
• Use a fine-tooth comb or special nit comb to remove dead lice and nits. 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 Xeglyze is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Head Lice (must meet all):

1. Diagnosis of head lice;
2. Age ≥ 6 months;

3. Failure of two preferred agents indicated for head lice (see Appendix B for examples), used in the last 60 days, unless clinically significant adverse effects are experienced or all are contraindicated;

   4. Dose does not exceed 1 bottle for a single use. Approval duration: 14 days 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: Page 1 of 6

   CLINICAL POLICY Abametapir 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. Head Lice
   3. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):
   4. 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
   5. 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, 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.
      Page 2 of 6

   Dose Limit/ Maximum Dose 2 topical treatments applied 7-10 days apart; if the first treatment is applied to wet hair, repeat treatment should be applied in 24 hours One application to affected area 1 application/week 1 tube/topical application 1 application (roughly 30 mL) CLINICAL POLICY Abametapir Drug Name Dosing Regimen pyrethrins/piperonyl butoxide permethrin 1% cream rinse/lotion benzyl alcohol 5% lotion (Ulesfia®)
   ivermectin 0.5% lotion (Sklice®) malathion 0.5% lotion (Ovide®) Adults, adolescents, and children 2 to 12 years: Apply liberally to dry hair and scalp or skin. For head lice, apply first to back of neck and behind ears. Use enough product to cover entire hair shaft. Allow product to remain on affected areas for 10 minutes, but no longer. Rinse thoroughly and dry affected areas with a clean towel. Repeat application once in 7 to 10 days. If the first treatment was applied to wet hair, the hair should be rinsed, dried, and then the product should be reapplied in 24 hours. Repeat application on dry hair in 7 to 10 days. Adults, adolescents, children, and infants ≥ 2 months: Shampoo hair with regular shampoo, rinse and towel dry. Then, apply permethrin 1% lotion sufficient to saturate the hair and scalp (usually 25 to 30 mL), especially behind the ears and on the nape of the neck. Leave on hair for 10 minutes but no longer. Then, rinse thoroughly with water. If live lice are seen 7 days or more after the first application, a second treatment should be given. Adults, adolescents, and children ≥ 6 months: Apply to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat application after 7 days. Adults, adolescents, and children ≥ 6 months: Apply to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp. Leave on the hair and scalp for 10 minutes, and then rinse off with water. The tube is intended for single use; discard any unused portion.
   Adults, adolescents, and children ≥ 6 years: Apply to dry hair and scalp. Apply as a single topical application in a sufficient amount (roughly 30 mL) to saturate hair and scalp. Leave on hair for 8-12 hours but no longer. Then, rinse thoroughly and shampoo with a non-medicated shampoo. After rinsing, use a nit comb to remove the dead lice and the nits (eggs) from the hair. Retreatment is not frequently required. A second treatment may Page 3 of 6

   CLINICAL POLICY Abametapir Drug Name Dosing Regimen spinosad 0.9% topical suspension (Natroba®) be given if live lice are seen 7-9 days or more after the first application. Adults, adolescents, children, and infants ≥ 6 months: Apply a sufficient amount of spinosad suspension to cover dry scalp and hair; up to one bottle (120 mL) may be required depending on the length of hair. Leave on for 10 minutes and then rinse thoroughly with warm water. If live lice are still seen 7 days after the first treatment, apply a second treatment. Dose Limit/ Maximum Dose 120 mL/application 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. *Over-the-counter Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
   Indication Dosing Regimen Head lice Apply Xeglyze to dry hair in an amount sufficient (up to the full content of one bottle) to thoroughly coat the hair and scalp. Massage Xeglyze into the scalp and throughout the hair; leave on the hair and scalp for 10 minutes and then rinse off with warm water. Treatment with Xeglyze involves a single application. Discard any unused product.
   Maximum Dose 1 application VI. Product Availability
   Bottle containing lotion (filled to a nominal 200 g [approximately 7 oz or 210 mL]): 0.74% (w/w) VII.