ModifiedmhnPolicy CP.PMN.105

Tavaborole (Kerydin) for toenail onychomycosis

Policy governing prior authorization and coverage criteria for tavaborole (brand Kerydin) for treatment of toenail onychomycosis for members covered under the payer's lines of business.

Policy Summary

Payermhn

PolicyTavaborole (Kerydin) for toenail onychomycosis

Policy CodePolicy CP.PMN.105

Change TypeStep therapy bypass (IL HIM)generic-first and dose-limit clarifications

Effective DateMar 1, 2018

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating criteria are met (diagnosis, age, prior therapy or contraindication, and dose limits).

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Requirement for use of generic tavaborole for brand Kerydin requests was added.

Dose limits clarified to 10 mL (1 bottle) per 30 days.

48 weeksmax approval duration

10 mL/30ddose limit

≥6 yrsminimum age

T. rubrum / T. mentagrophytesFDA pathogens

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for onychomycosis:

Initial Approval - Onychomycosis: 1. Diagnosis of onychomycosis of the toenails; 2. Age ≥ 6 years; 3. If age ≥ 18 years, member meets one of the following: (a) failure of a 12-week trial of oral terbinafine at up to maximally indicated doses within the past 12 months; OR (b) intolerance or contraindication to oral terbinafine AND failure of ciclopirox 8% topical solution unless contraindicated or clinically significant adverse effects occur; 4. If request is for brand Kerydin, member must use generic tavaborole unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 10 mL (1 bottle) per 30 days.see node text

Approval duration: 48 weeks

Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy - Onychomycosis: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 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.see node text

Approval duration: up to 48 weeks of total treatment

Alternative/Off-label Requests

Requests for other diagnoses/indications (not specified) — all must be met:

Other Indications: 1. If request is for brand Kerydin, member must use generic tavaborole unless contraindicated or clinically significant adverse effects are experienced; 2. One of the following must apply: (a) If the drug has undergone a recent label change (within the last 6 months) not reflected in this policy, follow the referenced formulary/non-formulary policies for the relevant line of business; OR (b) If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 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, CP.PMN.53 for Medicaid).see node text

See referenced policies for formulary/non-formulary or off-label handling

Coverage for non‑FDA approved indications that are not specifically addressed in this policy is not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the payer's off‑label use requirements. Applicable off‑label policies are: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid). Requests for off‑label use should include the clinical evidence and rationale required by those referenced policies to be considered for coverage.

Coverage is not authorized for requests that propose use of tavaborole for non‑FDA indications when the submission lacks the required documentation demonstrating efficacy and safety as outlined in the payer's off‑label use policies. Providers should follow the referenced off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) when submitting supporting evidence; absence of such documentation may result in denial of the request.

When caring for Medicaid members, state Medicaid coverage provisions take precedence if they conflict with this clinical policy. Providers and reviewers must follow the applicable state Medicaid manual and coverage rules for such members; in cases of conflict, the state Medicaid requirements control coverage decisions.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required — tavaborole/Kerydin are medically necessary only when policy criteria are met. Providers must obtain prior authorization before dispensing tavaborole (generic) or Kerydin (brand) per the clinical policy.

Applies to tavaborole and Kerydin requests
Dose limit: ≤ 10 mL (1 bottle) per 30 days
If brand Kerydin requested, member must use generic tavaborole unless contraindicated or adverse effects

Documentation Required

Required Supporting Documentation

Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Failure to submit required documentation or to meet the policy criteria may result in denial of the request.

Include supporting clinical evidence of diagnosis, prior therapies, and rationale for exceptions as applicable
Documentation deficiency or noncompliance may lead to claim denial or request denial

Step Therapy

Step Therapy and State Bypass

Step therapy requirements apply as specified in the clinical policy (including prior trial of oral terbinafine or ciclopirox topical where indicated). For Illinois HIM requests, the step therapy requirements do not apply per Illinois HB 5395 effective 1/1/2026 — IL Medicaid/state rules may provide additional or different requirements.

Step therapy: failure of 12-week trial of oral terbinafine within past 12 months or intolerance/contraindication to terbinafine plus failure of ciclopirox 8% topical solution unless contraindicated
IL HB 5395: step therapy bypass for Illinois HIM effective 01/01/2026

Note

Clinical Policy Governs Coverage; Medicaid Precedence

Tavaborole clinical policy governs coverage decisions for these products. For Medicaid members, when state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. Providers should consult the applicable state Medicaid manual for specific Medicaid coverage rules.

This clinical policy is the governing coverage document for tavaborole/Kerydin unless superseded by state Medicaid rules
Medicaid precedence: state Medicaid rules override when conflicts exist

Note

Provider Responsibility and Policy Binding

Provider responsibilities and legal notice: This clinical policy is a coverage guide and does not constitute medical advice or direct the practice of medicine. Providers are expected to exercise independent professional judgment when treating members and are solely responsible for medical advice and treatment decisions. The policy is property of the Health Plan; unauthorized use is prohibited and providers submitting claims agree to be bound by the policy terms.

Providers are independent contractors and not agents of the Health Plan
Providers remain responsible for clinical decisions despite policy guidance

OpenPayer

Tavaborole (Kerydin) for toenail onychomycosis

Coverage Criteria

Coding and Limits

Provider Actions and Prior Authorization

Background

Definitions