CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Itraconazole (Sporanox) capsule coverage

Defines medical policy criteria, required documentation, and authorization durations for coverage of itraconazole (Sporanox) oral capsules for various fungal infections and prophylaxis in eligible patients.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyItraconazole (Sporanox) capsule coverage

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateJan 29, 2025

Key ActionPrior authorization is required and may be granted only when all coverage criteria are met and approval durations align with the listed durations (3, 6, or 12 months depending on indication).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthstypical approval duration

12 monthshistoplasmosis / chronic prophylaxis

3 monthssuperficial infections / onychomycosis

280-Ainternal ref

Coverage Criteria for Itraconazole (Sporanox) Capsules

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Covered Indications (Authorization when ALL applicable criteria are met)

Authorization may be granted for the requested drug when ALL of the following are met:

General exclusion: The requested drug is NOT being used in a footbath.

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Covered indications — group A: The requested drug is being prescribed for ANY of the following: pityriasis versicolor (tinea versicolor); onychomycosis due to dermatophytes (tinea unguium) confirmed by a fungal diagnostic test (KOH preparation, fungal culture, or nail biopsy); coccidioidomycosis prophylaxis in HIV infection; histoplasmosis prophylaxis in HIV infection; invasive fungal infection prophylaxis in a patient with chronic granulomatous disease; primary therapy for chronic cavitary pulmonary aspergillosis.

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Covered indications — group B: The requested drug is being prescribed for ANY of the following additional indications: blastomycosis; primary therapy for allergic bronchopulmonary aspergillosis (in combination with systemic corticosteroids); histoplasmosis; aspergillosis in a patient intolerant of or refractory to amphotericin B; cryptococcosis; coccidioidomycosis; sporotrichosis; microsporidiosis; talaromycosis (formerly penicilliosis); invasive fungal infection prophylaxis in a liver transplant patient; invasive fungal infection prophylaxis in a patient with a hematologic malignancy.

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Dermatophyte skin infection step therapy: For tinea corporis, tinea cruris, tinea capitis, tinea manuum, or tinea pedis, the patient experienced inadequate treatment response, intolerance, or has a contraindication to ANY of the following: fluconazole, griseofulvin, terbinafine.

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The policy explicitly excludes use of itraconazole capsules in a footbath. Requests where the drug is administered or intended for use in a footbath will not meet coverage criteria and are prohibited.

Authorization requires diagnostic confirmation for certain indications. For example, onychomycosis due to dermatophytes must be confirmed by a fungal diagnostic test such as a potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy prior to approval. Requests that lack the specified diagnostic confirmation or that are for prohibited uses (e.g., footbath) are considered not medically necessary under this policy.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior authorization required; approvals conditional on meeting all criteria

Prior authorization is required and will be granted only when all coverage criteria are met. Approval durations depend on the indication: 3 months for superficial infections and onychomycosis, 6 months for many invasive infections and certain systemic indications, and 12 months for histoplasmosis and selected prophylaxis/chronic cavitary pulmonary aspergillosis.

Authorization granted only when ALL coverage criteria are met.
Duration of approval (DOA) aligned to indication: 3, 6, or 12 months as specified.

Step Therapy

Step therapy: trial of specified alternatives required for dermatophyte skin infections

For tinea corporis/cruris/capitis/manuum/pedis (dermatophyte skin infections), the patient must have had an inadequate response to, intolerance of, or a contraindication to fluconazole, griseofulvin, or terbinafine before itraconazole will be approved.

Step requirement applies to tinea corporis, tinea cruris, tinea capitis, tinea manuum, and tinea pedis.
Must document inadequate response, intolerance, or contraindication to fluconazole, griseofulvin, or terbinafine.

Documentation Required

Obtain fungal diagnostic testing (KOH, culture, or nail biopsy) before treatment

Obtain appropriate specimens for fungal diagnostic testing prior to initiating therapy for onychomycosis: potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy. Other relevant laboratory studies (wet mount; histopathology; serology) should be obtained before therapy to isolate and identify causative organisms.

Confirm onychomycosis with KOH preparation, fungal culture, or nail biopsy prior to treatment.
Obtain fungal cultures and other relevant laboratory studies before therapy; treatment may begin empirically but specimens should still be obtained.

Denial Risk

Prohibited use: drug use in a footbath will be denied

Requests will be denied if the requested drug is being used in a footbath; the requested drug must NOT be used in a footbath to meet coverage criteria.

Use of the drug in a footbath is an explicit exclusion and will result in denial.

Background

Itraconazole capsules (Sporanox) are used for a range of systemic and superficial fungal infections. Covered indications in this policy include treatment of conditions such as pityriasis versicolor (tinea versicolor) and confirmed onychomycosis due to dermatophytes, as well as prophylaxis for coccidioidomycosis or histoplasmosis in persons with HIV, invasive fungal infection prophylaxis in chronic granulomatous disease, and primary therapy for chronic cavitary pulmonary aspergillosis. Coverage is contingent on meeting the listed criteria, including diagnostic confirmation where specified.

Definitions

Onychomycosis due to dermatophytes (tinea unguium)

DefinitionFungal infection of the toenail or fingernail caused by dermatophyte organisms (tinea unguium).

Diagnostic confirmation requiredDiagnosis should be confirmed prior to initiating itraconazole by KOH preparation, fungal culture, or nail biopsy.

Specimen guidanceObtain appropriate nail specimens for laboratory testing (KOH, fungal culture, or nail biopsy) before therapy; treatment may be started empirically but confirmatory testing is recommended.

Anatomic sitesToenail and/or fingernail involvement are included.

Drug indication contextOnychomycosis due to dermatophytes is a listed FDA indication for itraconazole (Sporanox) capsules.