SKLICE, Ivermectin (Pediculicide) Form

Ivermectin tablet (Stromectol®) is an anthelmintic agent. Ivermectin lotion (Sklice®) is a pediculicide. FDA Approved Indication(s) Stromectol is indicated for the treatment of: • Intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. o This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200 mcg/kg dose of ivermectin. • Onchocerciasis due to the nematode parasite Onchocerca volvulus. o This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). o Limitation(s) of use: Stromectol has no activity against adult Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites. Sklice is indicated for the topical treatment of head lice infestations in patients 6 months 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 ivermectin is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Head Lice (must meet all):

1. Request is for ivermectin lotion;

   2. Diagnosis of head lice;
   3. Age ≥ 6 months;
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   CLINICAL POLICY Ivermectin

2. Failure of permethrin 1% cream, used in the last 60 days, unless contraindicated or clinically significant adverse effects are experienced;
3. Request does not exceed 1 tube for a single use. Approval duration: 14 days B. All Other Indications (must meet all):
4. Request is for generic ivermectin tablets;
   2. Request is not for the prevention or treatment of coronavirus disease 2019 (COVID- 19);
5. Dose does not exceed health plan quantity limit, if applicable. Approval duration: 12 months C. Other diagnoses/indications (must meet 1 or 2):
6. 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
7. 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
8. Re-authorization is not permitted. Members must meet the initial approval criteria.
   Approval duration: Not applicable
   B. All Other Indications (must meet all):
9. Request is for generic ivermectin tablets;
   2. Request is not for the prevention or treatment of coronavirus disease 2019 (COVID- 19);

10. If request is for a dose increase, new dose does not exceed health plan quantity limit, if applicable. Approval duration: 12 months Page 2 of 7

    CLINICAL POLICY Ivermectin C. Other diagnoses/indications (must meet 1 or 2):

11. 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

12. 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.
    B. Ivermectin tablets for the prevention or treatment of coronavirus disease 2019 (COVID- 19). 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 Dose Limit/ Maximum Dose One application to affected area permethrin 1% cream rinse/lotion Head lice 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. Page 3 of 7

    CLINICAL POLICY Ivermectin 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 Appendix D: General Information • The National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines World Health Organization (WHO) Therapeutics and COVID-19 living guideline recommend against the use of ivermectin tablets for the prevention or treatment COVID-19 at this time due to insufficient evidence regarding the benefits and harms of the treatment based on current evidence.
    V. Dosage and Administration Drug Name Indication Dosing Regimen Ivermectin (Stromectol) tablets Onchocerciasis Doses should be prescribed to provide approximately 150 mcg of ivermectin per kg of body weight: Maximum Dose 150 mcg/kg/dose Body Weight (kg) 15 to 25 26 to 44 45 to 64 65 to 84 ≥ 85 Single Oral Dose Number of 3-mg Tablet(s) 1 tablet 2 tablets 3 tablets 4 tablets 150 mcg/kg Strongyloidiasis Doses should be prescribed to provide approximately 200 mcg of ivermectin per kg of body weight: 200 mcg/kg/dose Head lice
    Ivermectin (Sklice) lotion 0.5% Body Weight (kg) Single Oral Dose Number of 3-mg Tablet(s) 1 tablet 2 tablets 3 tablets 4 tablets 5 tablets
    200 mcg/kg 15 to 24 25 to 35 36 to 50 51 to 65 66 to 79 ≥ 80 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. 1 tube/ topical application Page 4 of 7

    CLINICAL POLICY Ivermectin Drug Name Indication Dosing Regimen Maximum Dose The tube is intended for single use; discard any unused portion. VI. Product Availability
    Drug Name Ivermectin (Stromectol)
    Ivermectin (Sklice) Availability Tablet: 3 mg Lotion 0.5%: 117 g (tube) VII.