CurrentBlue Cross Blue Shield - IowaPolicy 05.02.00

Topical onychomycosis therapy prior authorization (Jublia, Kerydin)

Defines prior authorization, medical necessity criteria, documentation, quantity limits, and approval duration for topical efinaconazole (Jublia) and tavaborole (Kerydin) for toenail onychomycosis for Wellmark/Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTopical onychomycosis therapy prior authorization (Jublia, Kerydin)

Policy CodePolicy 05.02.00

Change TypeNo material change

Effective DateSep 6, 2016

Next Review Date

Key ActionObtain prior authorization with laboratory confirmation of fungal etiology and documentation that all clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

48 weeksapproval duration

4 mL/30 daysJublia quantity limit

≤50%max nail involvement

lab requireddiagnosis confirmation

Coverage Criteria

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Initial coverage criteria

Covered when ALL of the following are met

Primary criteria: Diagnosis is distal lateral subungual onychomycosis with laboratory confirmation of fungal etiology (e.g., positive KOH stain, fungal culture, or nail biopsy)

Clinical extent: 50% or less clinical involvement of target toenail(s) with no lunula involvement or dermatophytomas present<=50%

Medical indication: Treatment is requested for a medical indication and not for cosmetic purposes (examples: immunocompromised patients; history of lower-extremity cellulitis; diabetes with additional risk factors for cellulitis; extensive nail involvement causing severe pain or limiting ambulation)

Prior systemic therapy: Patient has documented failure with or contraindication to BOTH oral therapies: terbinafine AND itraconazole

Prior topical therapy: Patient experienced inadequate response, adverse event, intolerance, or contraindication to a 48-week treatment course of generic ciclopirox despite good adherence48 weeks

Monotherapy: Treatment is intended as monotherapy and not to be combined with oral systemic therapy

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include laboratory confirmation of fungal etiology (e.g., positive KOH, fungal culture, or nail biopsy) and documentation that the clinical criteria below are met.

A copy of laboratory testing results (KOH, culture, or biopsy) must be submitted with the prior authorization request
Indicate percent clinical involvement of target toenail(s) and absence of lunula involvement or dermatophytoma

Step Therapy

Step Therapy / Prior Treatment Requirement

Step therapy: patient must have documented failure of, intolerance to, or a contraindication to BOTH oral antifungal therapies terbinafine AND itraconazole prior to approval for topical Jublia (efinaconazole) or Kerydin (tavaborole).

Document prior trials including dates, duration, reason for discontinuation, and outcome for both terbinafine and itraconazole

Documentation Required

Required Documentation

Required documentation: submit laboratory testing results confirming fungal etiology (positive KOH, fungal culture, or nail biopsy) and clinical documentation addressing nail involvement, medical necessity (not cosmetic), prior topical and oral treatment history, and rationale for topical therapy.

Laboratory confirmation (KOH, culture, or biopsy) required
Clinical note documenting percent nail involvement (must be ≤ 50% for approval), absence of lunula involvement and no dermatophytoma
Documentation of medical necessity (e.g., immunocompromised status, history of cellulitis, diabetes with risk factors, severe pain/ambulation limits)
Documentation of prior ciclopirox treatment (48-week course) with adherence and inadequate response, adverse event, intolerance, or contraindication

Denial Risk

Denial Triggers / Not Medically Necessary

Denial triggers: therapy may be denied if approval criteria are not met — examples include greater than 50% nail involvement, lunula involvement or dermatophytoma, lack of laboratory confirmation of fungal etiology, or absence of documented failure/contraindication to both oral therapies.

>50% clinical involvement of target toenail(s)
Lunula involvement or presence of dermatophytoma
No laboratory confirmation of fungal etiology submitted
No documentation of prior terbinafine AND itraconazole trials (failure, intolerance, or contraindication)

Definitions

inv-11: Onychomycosis (distal lateral subungual) — definition and typical pathogens (Trichophyton spp.).

DefinitionOnychomycosis (distal lateral subungual): fungal infection of the toenail characterized by distal lateral subungual involvement

Typical pathogensDermatophytes: Trichophyton rubrum and Trichophyton mentagrophytes

Diagnostic requirementFungal etiology must be confirmed by appropriate laboratory testing (e.g., positive KOH stain, fungal culture, or nail biopsy)

Treatment contextPolicy applies to topical therapies Jublia (efinaconazole) and Kerydin (tavaborole) for toenail onychomycosis due to Trichophyton spp.

Background

Efinaconazole (Jublia) and tavaborole (Kerydin) are topical antifungal agents approved for the treatment of toenail onychomycosis due to dermatophytes. Per policy, these agents are reserved for patients with laboratory-confirmed distal lateral subungual onychomycosis who meet additional criteria intended to select patients for whom topical therapy is appropriate. Key limits include maximum 50% clinical involvement of the target toenail(s) with no lunula or dermatophytoma involvement, requirement that treatment be for a medical indication (not cosmetic), prior failure or contraindication to both oral agents (terbinafine and itraconazole), and an inadequate response or intolerance to a 48-week course of generic ciclopirox despite good adherence. Approval when criteria are met is for 48 weeks (single lifetime approval).

OpenPayer

Topical onychomycosis therapy prior authorization (Jublia, Kerydin)

Coverage Criteria

Procedures and Coding

Provider Actions & Authorization Requirements

Definitions

Background