Centene itraconazole Coverage & Prior Auth Policy

Coverage Criteria for Itraconazole Products

Initial Therapy

Itraconazole products are medically necessary when the following indication-specific criteria are met.

I. A. Onychomycosis (Initial): 1) Diagnosis of onychomycosis; 2) Request is for Sporanox capsules or itraconazole capsules; 3) If request is for brand Sporanox, member must use generic itraconazole capsules unless contraindicated or clinically significant adverse effects are experienced; 4) Member meets one of: a) fingernail disease — failure of a 6-week trial of oral terbinafine 250 mg/day unless contraindicated or adverse effects; b) toenail disease — failure of a 12-week trial of oral terbinafine 250 mg/day unless contraindicated or adverse effects; 5) Dose does not exceed 400 mg (4 capsules) per day.dose <= 400 mg/day

Approval duration: fingernail 2 months; toenail 3 months

I. B. Oropharyngeal Candidiasis (Initial): 1) Diagnosis of oropharyngeal candidiasis; 2) Request is for Sporanox oral solution or itraconazole oral solution; 3) If request is for brand Sporanox, member must use generic itraconazole oral solution unless contraindicated or clinically significant adverse effects are experienced; 4) Failure of a 7-day trial of nystatin suspension or clotrimazole troches/lozenges unless contraindicated or adverse effects; 5) Failure of a 7-day trial of fluconazole unless contraindicated or adverse effects; 6) Dose does not exceed 200 mg (20 mL) per day.dose <= 200 mg/day

Approval duration: 4 weeks

I. C. Esophageal Candidiasis (Initial): 1) Diagnosis of esophageal candidiasis; 2) Request is for Sporanox oral solution or itraconazole oral solution; 3) If request is for brand Sporanox, member must use generic itraconazole oral solution unless contraindicated or clinically significant adverse effects are experienced; 4) Failure of a 14-day trial of fluconazole at up to maximally indicated doses unless contraindicated or adverse effects; 5) Dose does not exceed 200 mg (20 mL) per day.dose <= 200 mg/day

Approval duration: 4 weeks

I. D. Aspergillosis (Initial): 1) Diagnosis of aspergillosis; 2) Request is for Sporanox capsules, Tolsura, or itraconazole capsules; 3) If request is for brand Sporanox or Tolsura, member must use generic itraconazole capsules unless contraindicated or clinically significant adverse effects are experienced; 4) Failure of a 3-month trial of voriconazole at up to maximally indicated doses unless contraindicated or adverse effects; 5) Dose does not exceed: a) itraconazole/Sporanox capsules 400 mg (4 capsules)/day OR b) Tolsura capsules 260 mg (4 capsules)/day.400 mg/day or 260 mg/day depending on product

Prior authorization may be required for voriconazole

I. E. Blastomycosis or Histoplasmosis (Initial): 1) Diagnosis of blastomycosis or histoplasmosis; 2) Request is for Sporanox capsules, Tolsura, or itraconazole capsules; 3) If request is for brand Sporanox or Tolsura, member must use generic itraconazole capsules unless contraindicated or clinically significant adverse effects are experienced; 4) Dose does not exceed: a) itraconazole/Sporanox capsules 400 mg (4 capsules)/day OR b) Tolsura capsules 260 mg (4 capsules)/day.400 mg/day or 260 mg/day depending on product

Approval duration: blastomycosis 6 months; histoplasmosis 6 weeks

I. F. Hematologic Malignancy (off-label, Initial): 1) Diagnosis of hematologic malignancy; 2) Member must use generic itraconazole capsules or oral solution unless contraindicated or clinically significant adverse effects are experienced; 3) Request is for prophylaxis of aspergillosis OR prophylaxis of candidiasis with prior failure of fluconazole at up to maximally indicated doses unless contraindicated or adverse effects; 4) Dose does not exceed: a) itraconazole/Sporanox capsules 400 mg (4 capsules)/day; b) itraconazole/Sporanox oral solution 200 mg (20 mL)/day; c) Tolsura capsules 260 mg (4 capsules)/day.product-specific dose limits

I. G. Coccidioidomycosis (off-label, Initial): 1) Diagnosis of coccidioidomycosis and member has one of: a) HIV-1 with peripheral blood CD4 < 250 cells/mm3; b) focal pulmonary disease; c) disseminated extrathoracic nonmeningeal or meningeal disease; 2) Request is for Sporanox or itraconazole capsules or oral solution; 3) Prescribed by or in consultation with an infectious disease specialist, pulmonologist, or HIV specialist; 4) If request is for brand Sporanox, member must use generic itraconazole capsules or oral solution unless contraindicated or clinically significant adverse effects are experienced; 5) Failure of fluconazole at up to maximally indicated doses unless contraindicated or adverse effects; 6) Dose limits: a) disseminated extrathoracic nonmeningeal or meningeal — capsules 600 mg/day or oral solution 600 mL/day; b) HIV-1 co-infection — 600 mg/day for first 3 days then 400 mg/day thereafter (capsules) or analogous oral solution regimen; c) all other infections — capsules 400 mg/day or oral solution 400 mL/day.varies by presentation; up to 600 mg/day for certain presentations

Approval duration: 6 months

I. H. Sporotrichosis (off-label, Initial): 1) Diagnosis of sporotrichosis and member has one of: a) lymphocutaneous, cutaneous, non-severe pulmonary or osteoarticular sporotrichosis; b) severe pulmonary, meningeal, or disseminated systemic sporotrichosis; 2) Request is for Sporanox or itraconazole capsules or oral solution; 3) Prescribed by or in consultation with an infectious disease specialist or pulmonologist; 4) If request is for brand Sporanox, member must use generic itraconazole capsules or oral solution unless contraindicated or clinically significant adverse effects are experienced; 5) For severe forms, previous use of amphotericin B unless contraindicated or adverse effects; 6) Dose does not exceed: a) capsules 400 mg (4 capsules)/day OR b) oral solution 400 mL/day.dose <= 400 mg/day

Approval duration: see policy

I. I. Other indications: 1) If the drug has had a recent label change within last 6 months not reflected in this policy, refer to the specified formulary/no-coverage or non-formulary policies; 2) If requested use is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

References to other Centene policies provided

Continuation Therapy

Coverage for continued therapy is authorized when the member meets the following:

II. A. Onychomycosis (Continued): 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is under continuity of care regulation; 2) Member is responding positively to therapy; 3) Request is for Sporanox oral capsules or itraconazole capsules; 4) If request is for brand Sporanox, member must use generic itraconazole capsules unless contraindicated or clinically significant adverse effects are experienced; 5) Member has not received more than 90 days of treatment; 6) If request is for a dose increase, new dose does not exceed 400 mg (4 capsules) per day.<= 90 days total; dose <= 400 mg/day

Approval duration: fingernail up to 2 months total; toenail up to 3 months total

II. B. Oropharyngeal/Esophageal Candidiasis (Continued): 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is under continuity of care regulation; 2) Member is responding positively to therapy; 3) Request is for Sporanox oral solution or itraconazole oral solution; 4) If request is for brand Sporanox, member must use generic itraconazole oral solution unless contraindicated or clinically significant adverse effects are experienced; 5) If request is for a dose increase, new dose does not exceed 200 mg (20 mL) per day.dose <= 200 mg/day

Hematologic Malignancy (off-label)

Hematologic malignancy (off-label) — coverage when ALL of the following are met:

Hematologic malignancy off-label criteria: 1) Member meets one of: a) currently receiving medication via Centene benefit or previously met initial approval criteria; b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Member must use generic itraconazole capsules or oral solution unless contraindicated or clinically significant adverse effects are experienced; 3) Member is responding positively to therapy; 4) If request is for a dose increase, new dose does not exceed: a) itraconazole/Sporanox capsules 400 mg (4 capsules)/day; b) itraconazole/Sporanox oral solution 200 mg (20 mL)/day; c) Tolsura capsules 260 mg (4 capsules)/day.product-specific dose limits

Approval duration: 6 months

Coccidioidomycosis (off-label)

Coccidioidomycosis (off-label) — coverage when ALL of the following are met:

Coccidioidomycosis off-label criteria: 1) Member meets one of: a) currently receiving medication via Centene benefit or previously met initial approval criteria; b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Request is for Sporanox or itraconazole capsules or oral solution; 3) If request is for brand Sporanox, member must use generic itraconazole capsules or oral solution unless contraindicated or clinically significant adverse effects are experienced; 4) If HIV-1 positive, member has peripheral blood CD4 < 250 cells/mm3; 5) Failure of fluconazole at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced; 6) If request is for a dose increase, new dose does not exceed: a) disseminated extrathoracic nonmeningeal or meningeal — capsules 600 mg (6 capsules)/day or oral solution 600 mL/day; b) for HIV-1 co-infection — capsules 600 mg/day for first 3 days then 400 mg/day thereafter (oral solution analogous); c) all other infections — capsules 400 mg (4 capsules)/day or oral solution 400 mL/day.CD4 < 250 cells/mm3 for HIV-positive members when applicable

Approval duration: 12 months

Sporotrichosis (off-label)

Sporotrichosis (off-label) — coverage when ALL of the following are met:

Sporotrichosis off-label criteria: 1) Member meets one of: a) currently receiving medication via Centene benefit or previously met initial approval criteria; b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Request is for Sporanox or itraconazole capsules or oral solution; 3) If request is for brand Sporanox, member must use generic itraconazole capsules or oral solution unless contraindicated or clinically significant adverse effects are experienced; 4) For severe pulmonary, meningeal, or disseminated systemic sporotrichosis, previous use of amphotericin B unless contraindicated or clinically significant adverse effects are experienced; 5) If request is for a dose increase, new dose does not exceed: a) capsules 400 mg (4 capsules)/day; b) oral solution 400 mL/day.dose limits as specified

Approval duration: 12 months

Other diagnoses/indications

Other diagnoses/indications — coverage pathway

Other uses: 1) If this drug has had a label change within the last 6 months not yet reflected in this policy, refer to the specified formulary/no-coverage or non-formulary policies for the relevant line of business (see policy references in text); 2) If the requested use is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for marketplace/ICHRA, CP.PMN.53 for Medicaid).

See specified policy numbers for process

Tolsura is not indicated for the treatment of onychomycosis and is not interchangeable or substitutable with other itraconazole products. This limitation of use applies when evaluating requests for itraconazole therapy and selecting appropriate formulations for onychomycosis.

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy: CP.CPA.09 (commercial), HIM.PA.154 (marketplace/ICHRA), or CP.PMN.53 (Medicaid), or unless coverage is provided by the member’s evidence of coverage documents.

Coverage determinations under this clinical policy are a guide to medical necessity and are subject to the member’s contract. All coverage is governed by the terms, conditions, exclusions, and limitations of the member’s coverage documents and by applicable state and federal requirements; the member’s plan documents and law take precedence where differences exist.

Uses that are non‑FDA approved and not addressed by this policy are considered not authorized in the absence of evidence meeting the referenced off‑label coverage criteria. Providers seeking coverage for such uses must follow the specified off‑label use policies and submit adequate clinical documentation to support efficacy and safety.

Dosing Limits and Relevant Clinical Thresholds

CD4

CD4 threshold for coccidioidomycosis (HIV-1)< 250 cells/mm³

ContextApplied when member is HIV-1 positive with coccidioidomycosis per continuation and initial criteria

Source guidanceUsed as part of coverage criteria to determine eligibility for itraconazole therapy in HIV-1 infected members

Itraconazole capsule daily max

Itraconazole (capsules) common maximum400 mg (4 capsules) per day

Usage contextsLimit applied for onychomycosis, blastomycosis, histoplasmosis, aspergillosis and many other indications unless higher-dose exception noted

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation (such as office chart notes, laboratory results, medication history, or other clinical information) supporting that the member has met all approval criteria. Failure to submit adequate supporting documentation may result in denial of the request.

Submit evidence of diagnosis and trials of required step-therapy agents when applicable (e.g., terbinafine for onychomycosis; nystatin or clotrimazole and fluconazole for oropharyngeal candidiasis; fluconazole for esophageal candidiasis; voriconazole for aspergillosis).
For continuation requests or dose increases, documentation must demonstrate prior receipt of the medication via the Centene benefit or eligibility under continuity-of-care regulations; include prior authorization history, clinical response, and reason for dose change.
Dose limits must be documented and requests exceeding listed maximums require justification and supporting clinical rationale.

Step Therapy

Step Therapy and Exceptions

Step therapy applies for multiple indications. Requests for brand Sporanox require trial and failure of generic itraconazole formulations (capsules or oral solution) unless there is documentation of contraindication or clinically significant adverse effects. Specific step requirements include terbinafine for onychomycosis and trials of first-line topical or oral agents for candidiasis per the criteria.

Background on Itraconazole

Itraconazole is an azole antifungal agent available in capsule and oral solution formulations and is indicated for multiple systemic and mucocutaneous mycoses. Approved indications include treatment of oropharyngeal and esophageal candidiasis (oral solution) and, for Sporanox capsules, treatment of dermatophyte onychomycosis of the toenail and fingernail in non‑immunocompromised patients, as well as systemic infections such as blastomycosis, histoplasmosis, and aspergillosis. Formulation‑specific limitations apply (for example, Tolsura is not indicated for onychomycosis), and dosing varies by indication and severity.

Definitions and Safety Information

Tolsura

DefinitionTolsura is an itraconazole formulation that is not indicated for treatment of onychomycosis

InterchangeabilityTolsura is not interchangeable or substitutable with other itraconazole products

Coverage implicationRequests for Tolsura are considered under product-specific dosing and are distinct from Sporanox/capsule policies

Contraindication - CHF

Contraindication statementItraconazole should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF

Indication-specific exceptionFor onychomycosis this contraindication applies to Sporanox capsules; oral solution may be used only for life‑threatening or serious infections despite CHF concern

OpenPayer

Itraconazole (Sporanox, Tolsura)

Coverage Criteria for Itraconazole Products

Dosing Limits and Relevant Clinical Thresholds

Prior Authorization, Documentation, and Step Therapy Requirements

Background on Itraconazole

Definitions and Safety Information