CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Itraconazole Sporanox Capsules Pa Policy 280 A 03 2022

Defines prior authorization coverage criteria for Sporanox (itraconazole) oral capsules, listing FDA-approved and compendial indications considered, required diagnostic confirmation for some indications, and prerequisite failure/intolerance to alternative antifungals.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyItraconazole Sporanox Capsules Pa Policy 280 A 03 2022

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for Sporanox (itraconazole) capsules; coverage is granted only when the policy criteria are met, including indication-specific requirements and documented failure/intolerance to listed alternatives.

SourceLink

POLICY UPDATE CHANGES

No material change to policy: has_material_change=false

MultipleCovered Indications

PA requiredAuthorization

OnychomycosisLab confirmation

Coverage Summary

Defines prior authorization coverage criteria for Sporanox (itraconazole) oral capsules and specifies that the product is covered with criteria. Coverage requires that requests meet the policy's indication-specific eligibility (FDA-approved and compendial indications are considered) and documentation requirements, including prerequisite failure/intolerance to specified alternative antifungals and exclusion of footbath use. For onychomycosis, the policy requires diagnostic confirmation prior to or documented at initiation (see diagnostic confirmation requirements).

Prior authorization is required and coverage is granted only when the policy criteria are met, which include: (1) the requested use corresponds to the listed FDA-approved or compendial indications and indication groups, (2) the itraconazole is not being used in a footbath, and (3) the patient has experienced inadequate response, intolerance, or contraindication to fluconazole, griseofulvin, or terbinafine when applicable.

General prior authorization coverage criteria

The requested drug will be covered with prior authorization when the following criteria are met:

ALL of the following

Indication groups (any of the following groups qualifies)
- Group A: Specific superficial and nail infections (non-immunocompromised)
  - Pityriasis versicolor
  - Tinea versicolor
  - Onychomycosis due to dermatophytes (Tinea unguium) confirmed by a fungal diagnostic test (e.g., potassium hydroxide [KOH] preparation, fungal culture, or nail biopsy)
- Group B: Disseminated, CNS, prophylaxis and chronic pulmonary aspergillosis
  - Disseminated histoplasmosis
  - Central nervous system (CNS) histoplasmosis
  - Histoplasmosis prophylaxis in HIV infection
  - Coccidioidomycosis prophylaxis in HIV infection
  - Invasive fungal infection prophylaxis in a patient with chronic granulomatous disease
  - Primary therapy for chronic cavitary pulmonary aspergillosis
- Group C: Other listed serious or compendial indications
  - Blastomycosis
  - Histoplasmosis
  - Primary therapy for allergic bronchopulmonary aspergillosis, in combination with systemic corticosteroids
  - Aspergillosis in a patient intolerant of or refractory to amphotericin B therapy
  - Coccidioidomycosis
  - Cryptococcosis
- Group D: Superficial tinea infections
  - Tinea corporis
  - Tinea cruris
  - Tinea capitis
  - Tinea manuum
  - Tinea pedis
The requested drug is not being used in a footbath
The patient experienced an inadequate treatment response, intolerance, or has a contraindication to any of the following: fluconazole, griseofulvin, terbinafine

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Provider actions & documentation requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Sporanox (itraconazole) capsules; coverage granted only when criteria in the policy are met (indication-specific and failure/intolerance to listed alternatives).

Documentation Required

Diagnostic confirmation for onychomycosis

For onychomycosis due to dermatophytes, document a confirmatory fungal diagnostic test. Acceptable tests to confirm the diagnosis include potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy.

Documentation Required

Avoid use in footbath

Ensure the requested itraconazole is not being used in a footbath; requests for footbath use are excluded.

Documentation Required

Prior antifungal trial requirement

Document prior inadequate response, intolerance, or contraindication to fluconazole, griseofulvin, or terbinafine.

Applicable Codes

This policy document does not enumerate specific billing or procedure codes for Sporanox (itraconazole) capsules. For applicable NDCs, CPT, or other billing codes and payer-specific coding guidance, consult the payer's coding resources or the full medical policy documentation and claims/billing references available from the plan or pharmacy benefit manager.

Background & Clinical Evidence

Sporanox (itraconazole) capsules are FDA-approved for treatment of several systemic fungal infections (including blastomycosis; histoplasmosis, including chronic cavitary pulmonary disease and disseminated non-meningeal histoplasmosis; and aspergillosis in patients intolerant of or refractory to amphotericin B) and for onychomycosis of the toenail and fingernail due to dermatophytes. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) are recommended before therapy, and appropriate nail specimens (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm onychomycosis prior to initiating treatment. Compendial uses include a range of prophylaxis and treatment indications such as coccidioidomycosis (and prophylaxis in HIV), cryptococcosis, histoplasmosis prophylaxis in HIV, invasive fungal infection prophylaxis in transplant and hematologic malignancy patients, microsporidiosis, talaromycosis, pityriasis versicolor, sporotrichosis, and various superficial tinea infections.

Primary source: Sporanox capsule package insert (Dec 2019) and multiple guideline/compendia references (Lexicomp, Micromedex, IDSA guidelines, etc.).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyItraconazole Sporanox Capsules Pa Policy 280 A 03 2022

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Itraconazole Sporanox Capsules Pa Policy 280 A 03 2022

Coverage Summary

General prior authorization coverage criteria

Provider actions & documentation requirements

Applicable Codes

Background & Clinical Evidence

Definitions

Revision History