CurrentmhnPolicy CP.PMN.25

Efinaconazole (Jublia) topical treatment for toenail onychomycosis

Covers medical necessity criteria, prior authorization expectations, and continuation rules for Jublia (efinaconazole) for treatment of toenail onychomycosis for members across commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyEfinaconazole (Jublia) topical treatment for toenail onychomycosis

Policy CodePolicy CP.PMN.25

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results, or other clinical information) demonstrating the member meets all approval criteria, including diagnosis, age, prior treatment history, and dosing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

48 weeksmaximum approval duration

Age ≥ 6minimum age

≤ 8 mLmax dose / 30 days

4 mL, 8 mLformulations

Coverage Criteria

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Onychomycosis initial criteria: 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 are experienced; 4) Dose does not exceed 8 mL (1 bottle) per 30 days

Approval duration: 48 weeks

inv-02: Continuation Therapy — Onychomycosis — Covered when ALL of the following are met

Covered when ALL of the following are met

Onychomycosis continuation criteria: 1) Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) Member has not received more than 48 weeks of treatment with Jublia; 4) If request is for a dose increase, new dose does not exceed 8 mL (1 bottle) per 30 days

Approval duration: up to 48 weeks of total treatment

inv-03: Other Indications / Off-label handling — Covered when one of the following is met

Covered when one of the following is met

Situations for other indications: 1) If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business as specified; 2) If the requested use is not listed under section III (diagnoses/indications not authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (see referenced policies)

Refer to specified related policies (formulary, non-formulary, or off-label use policies)

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the requestor provides sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Coding and Product Availability

Product availability / NDCNDC

NDC not listed

Solution (4 mL and 8 mL): 10% - product availability noted; no NDCs provided in document

inv-07: Maximum monthly supply — ≤ 8 mL per 30 days

Maximum monthly supply≤ 8 mL (1 bottle) per 30 days

Approval duration referenceInitial approval duration: 48 weeks; continued therapy up to 48 weeks total

Dose limit on dose-increase requestsIf request is for dose increase, new dose must not exceed 8 mL per 30 days

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and approval is granted only when the documented criteria for initial or continued therapy are met.

Step Therapy

Step Therapy for Adults

For adults (≥18 years) step therapy is required: either failure of a 12-week oral terbinafine trial within the past 12 months OR intolerance/contraindication to oral terbinafine plus failure of ciclopirox 8% topical solution unless contraindicated or not tolerated.

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria.

Denial Risk

Documentation/Indication Insufficiency

Requests that do not include documentation supporting that the member has met all approval criteria or requests for non‑FDA approved indications may be denied or require additional review. See off‑label use policies CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), and CP.PMN.53 (Medicaid) for required documentation when coverage of non‑FDA uses is sought.

Definitions

inv-13: Onychomycosis / Jublia indication — Onychomycosis: fungal infection of the toenails treatable with topical efinaconazole applied once daily for 48 weeks; indicated organisms noted

IndicationTopical treatment of onychomycosis of the toenail(s)

Causative organismsTrichophyton rubrum and Trichophyton mentagrophytes

Dosing regimenApply to affected toenails once daily for 48 weeks

Age considerationPolicy allows use for age ≥ 6 years (per initial approval criteria)

Formulation availabilitySolution available in 4 mL and 8 mL bottles (10%)

Background

Efinaconazole (Jublia) is a topical azole antifungal indicated for the treatment of toenail onychomycosis caused by Trichophyton rubrum and Trichophyton mentagrophytes. The product is formulated as a 10% solution and is applied once daily to affected toenails for an approved treatment course (typically up to 48 weeks). Formulation availability includes 4 mL and 8 mL solution bottles.