CurrentNeighborhood Health Plan of Rhode IslandPolicy Jublia PA with Limit Policy 1160-C 10-2022

Jublia (efinaconazole) topical solution prior authorization and quantity limits

Defines prior authorization requirements and quantity limits for Jublia (efinaconazole 10% topical solution) for treatment of toenail onychomycosis due to Trichophyton rubrum or T. mentagrophytes for members of Neighborhood Health Plan of Rhode Island (CVS Caremark criteria).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJublia (efinaconazole) topical solution prior authorization and quantity limits

Policy CodePolicy Jublia PA with Limit Policy 1160-C 10-2022

Change TypeNo material change

Effective DateOct 1, 2022

Next Review Date

Key ActionObtain prior authorization and document diagnostic confirmation and prior oral antifungal therapy (or intolerance/contraindication) before approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16 mLQty limit (short)

48 mLQty limit (long)

efinaconazole 10%Formulation

T. rubrum / T. mentagrophytesCovered organisms

Coverage Criteria

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Initial Authorization Criteria

Covered when ALL of the following are met except where OR clauses specify alternatives:

Primary diagnosis: The requested drug is being prescribed for onychomycosis of the toenail(s) due to Trichophyton rubrum or Trichophyton mentagrophytes

Diagnostic confirmation: The patient's diagnosis has been confirmed with a fungal diagnostic test (e.g., potassium hydroxide [KOH] preparation, fungal culture, or nail biopsy)

Oral antifungal prior therapy: Either the patient has experienced an inadequate treatment response to an oral antifungal therapy (e.g., terbinafine, itraconazole) OR the patient has experienced an intolerance to an oral antifungal OR the patient has a contraindication that would prohibit a trial of an oral antifungal therapy (e.g., terbinafine, itraconazole)

Usage restrictions: The requested drug is not being used in a footbath; if additional quantities are required, multiple toenails are being treated

The requested medication must not be administered via a footbath. Use of the drug in a footbath is explicitly prohibited by this policy.

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Jublia (efinaconazole 10% topical solution). Quantity limits apply: 16 mL per 21 days (for a 28-day fill) or 48 mL per 63 days (for an 84-day fill).

Quantity limits: 16 mL per 21 days or 48 mL per 63 days
Prior authorization required

Step Therapy

Oral Antifungal Trial Requirement

Documentation of an inadequate treatment response to an oral antifungal (e.g., terbinafine, itraconazole) is required prior to approval unless there is documented intolerance or a contraindication to oral therapy. If the patient has intolerance or a contraindication to oral antifungal therapy, document the specific intolerance or contraindication.

Required prior oral antifungal agents: terbinafine or itraconazole (or other appropriate oral antifungal)
Documented intolerance or contraindication to oral agents accepted in lieu of trial

Denial Risk

Documentation & Denial Conditions

Documentation of a fungal diagnostic test confirming onychomycosis is required (e.g., KOH preparation, fungal culture, or nail biopsy). Also document that the infection is due to Trichophyton rubrum or Trichophyton mentagrophytes. Coverage will be denied if the request is not for onychomycosis of the toenail(s) due to these organisms or if required documentation (diagnostic test result or prior oral therapy documentation) is not provided.

Acceptable diagnostic tests: KOH, fungal culture, nail biopsy
Indication must be onychomycosis of the toenail(s) due to T. rubrum or T. mentagrophytes
Coverage denied if diagnostic confirmation or required prior therapy documentation is missing

Background

Onychomycosis of the toenails is commonly caused by dermatophyte species such as Trichophyton rubrum and Trichophyton mentagrophytes. Jublia (efinaconazole topical solution, 10%) is an FDA‑approved topical azole antifungal indicated for treatment of toenail onychomycosis due to these organisms.

Per policy, Jublia is intended for topical application to affected toenails; prior authorization is required and coverage is limited to cases where the diagnosis is confirmed by a fungal diagnostic test (e.g., KOH preparation, fungal culture, or nail biopsy) and the patient has either had an inadequate response to an oral antifungal or has documented intolerance or a contraindication to oral therapy.

If additional quantities are needed for treatment of multiple nails, the policy specifies quantity limits (e.g., 16 mL per 21 days or 48 mL per 63 days), and use in a footbath remains prohibited.

Initial Therapy Criteria

Initial therapy requirements

Initial coverage requires:

FDA-indication: Indication must be toenail onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes

Diagnostic test: Documented fungal diagnostic test confirming the diagnosis (e.g., KOH preparation, fungal culture, or nail biopsy)

Oral therapy history: Inadequate response to an oral antifungal therapy OR documented intolerance to an oral antifungal OR documented contraindication to oral antifungal therapy (examples include terbinafine or itraconazole)

Step	Requirement
1	Trial and inadequate response to an oral antifungal therapy (e.g., terbinafine, itraconazole) is required unless the patient has documented intolerance to an oral antifungal or a contraindication that would prohibit a trial of an oral antifungal therapy