KERYDIN, Tavaborole Form

Tavaborole (Kerydin®) is an oxaborole antifungal.
FDA Approved Indication(s) Kerydin is indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. 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 Kerydin is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Onychomycosis (must meet all):

1. Diagnosis of onychomycosis of the toenails;
   2. Age ≥ 6 years;
   3. If age ≥ 18 years, member meets one of the following (a or b): a. Failure of a 12-week trial of oral terbinafine at up to maximally indicated doses within the past 12 months; b. Member has intolerance or contraindication to oral terbinafine, and failure of ciclopirox 8% topical solution, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for ciclopirox 8% topical solution
2. If request is for brand Kerydin, member must use generic tavaborole, unless contraindicated or clinically significant adverse effects are experienced;
3. Dose does not exceed 10 mL (1 bottle) per 30 days. Approval duration: 48 weeks
   B. Other diagnoses/indications (must meet all):
4. If request is for brand Kerydin, member must use generic tavaborole, unless contraindicated or clinically significant adverse effects are experienced;

5. One of the following (a or b): a. 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 (i or ii): Page 1 of 6

   CLINICAL POLICY Tavaborole i. 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 ii. 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 b. 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. Onychomycosis (must meet all):

6. 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. If request is for brand Kerydin, member must use generic tavaborole, unless contraindicated or clinically significant adverse effects are experienced;
   4. Member has not received more than 48 weeks of treatment with Kerydin;
   5. If request is for a dose increase, new dose does not exceed 10 mL (1 bottle) per 30 days. Approval duration: up to 48 weeks of total treatment B. Other diagnoses/indications (must meet all):
7. If request is for brand Kerydin, member must use generic tavaborole, unless contraindicated or clinically significant adverse effects are experienced;

8. One of the following (a or b): a. 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 (i or ii): i. 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 ii. 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 Page 2 of 6

   CLINICAL POLICY Tavaborole b. 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.
   Dosing Regimen Drug Name Dose Limit/ Maximum Dose 250 mg/day See dosing regimen terbinafine (Lamisil®) ciclopirox 8% topical solution (Penlac®) Toenail onychomycosis: 250 mg PO QD for 12 weeks Apply once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided.
   Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy. The safety and efficacy of using ciclopirox daily for > 48 weeks have not been established. 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 Onychomycosis Dosing Regimen Apply to affected toenails once daily for 48 weeks Once daily Maximum Dose VI. Product Availability
   Solution (4 mL and 10 mL bottles): 5% Page 3 of 6

   CLINICAL POLICY Tavaborole VII.