Health Net itraconazole Coverage & Prior Auth

Coverage Criteria for Itraconazole

Initial Therapy - Onychomycosis

Covered when ALL of the following are met

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 the following: a) Fingernail disease: failure of a 6-week trial of oral terbinafine 250 mg/day unless contraindicated or intolerant; b) Toenail disease: failure of a 12-week trial of oral terbinafine 250 mg/day unless contraindicated or intolerant; 5) Dose does not exceed 400 mg (4 capsules) per day.dose <= 400 mg/day

Approval duration: fingernail disease 2 months; toenail disease 3 months

Initial Therapy - Oropharyngeal Candidiasis

Covered when ALL of the following are met

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 intolerant; 5) Failure of a 7-day trial of fluconazole unless contraindicated or intolerant; 6) Dose does not exceed 200 mg (20 mL) per day.dose <= 200 mg/day

Approval duration: 4 weeks

Initial Therapy - Esophageal Candidiasis

Covered when ALL of the following are met

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 intolerant; 5) Dose does not exceed 200 mg (20 mL) per day.dose <= 200 mg/day

Approval duration: 4 weeks

Initial Therapy - Aspergillosis

Covered when ALL of the following are met

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 intolerant; 5) Dose does not exceed one of the following: a) itraconazole or Sporanox capsules 400 mg (4 capsules) per day; b) Tolsura capsules 260 mg (4 capsules) per day.dose <= 400 mg/day (or 260 mg/day for Tolsura)

Approval duration: specified per indication

Initial Therapy - Blastomycosis/Histoplasmosis

Covered when ALL of the following are met

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 one of the following: a) itraconazole or Sporanox capsules 400 mg (4 capsules) per day; b) Tolsura capsules 260 mg (4 capsules) per day.dose <= 400 mg/day (or 260 mg/day for Tolsura)

Approval duration: Blastomycosis 6 months; Histoplasmosis 6 weeks

Initial Therapy - Hematologic Malignancy (off-label)

Covered when ALL of the following are met

Hematologic malignancy prophylaxis: 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) Member meets one of the following (e.g., request for prophylaxis of candidiasis with prior failure of fluconazole at up to maximally indicated doses unless contraindicated); 4) Dose does not exceed one of the following: a) itraconazole or Sporanox capsules 400 mg (4 capsules) per day; b) itraconazole or Sporanox oral solution 200 mg (20 mL) per day; c) Tolsura capsules 260 mg (4 capsules) per day.dose <= specified limits

Approval duration: 6 months

Initial Therapy - Coccidioidomycosis (off-label)

Covered when ALL of the following are met

Coccidioidomycosis initial: 1) Diagnosis of coccidioidomycosis (disseminated, focal pulmonary, or other presentations as specified); 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 as applicable; 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 intolerant; 6) Dose does not exceed one of the following based on severity: a) Capsules: up to 600 mg/day initial dosing in some scenarios then 400 mg/day thereafter; b) Oral solution: up to 600 mg (60 mL)/day initial then 400 mg (40 mL)/day thereafter; c) Less severe infections: 400 mg/day (capsules or 40 mL solution).dose varies by severity (400-600 mg/day or 40-60 mL/day)

Approval duration: 6 months

Initial Therapy - Sporotrichosis (off-label)

Covered when ALL of the following are met

Sporotrichosis initial: 1) Diagnosis of sporotrichosis (lymphocutaneous, cutaneous, non-severe pulmonary, osteoarticular, or severe pulmonary/meningeal/disseminated as specified); 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 pulmonary, meningeal, or disseminated systemic sporotrichosis: previous use of amphotericin B is required unless contraindicated; 6) Dose does not exceed one of the following: a) Capsules: 400 mg (4 capsules) per day; b) Oral solution: 400 mg (40 mL) per day.dose <= 400 mg/day

Approval duration: specified per indication

Hematologic Malignancy (off-label)

Covered when ALL of the following are met

Hematologic Malignancy (off-label): Member is currently receiving medication via Centene benefit or previously met initial approval criteria; member meets continuity of care rules if applicable; member must use generic itraconazole capsules or oral solution unless contraindicated or clinically significant adverse effects are experienced; member is responding positively to therapy; dose increases must not exceed specified maxima (capsules 400 mg/day; oral solution 200 mg/day for some formulations; Tolsura 260 mg/day where applicable).see dosing limits

Approval duration: 6 months

Coccidioidomycosis (off-label)

Covered when ALL of the following are met

Coccidioidomycosis (off-label): Member is currently receiving medication via Centene benefit or previously met initial approval criteria; continuity of care rules apply if enrolled in applicable state/product; request is for Sporanox or itraconazole capsules or oral solution; generic-first requirement applies unless contraindicated; if HIV-1 positive special CD4-related dosing considerations apply; dose increase requests must not exceed specified maxima (capsules up to 600 mg/day initial in some scenarios then 400 mg/day; oral solution up to 600 mL/day initial then 400 mL/day thereafter); typical nonmeningeal dosing 400 mg/day.capsules up to 600 mg/day; solution up to 600 mL/day where specified

Approval duration: 12 months

Sporotrichosis (off-label)

Covered when ALL of the following are met

Sporotrichosis (off-label): Member is currently receiving medication via Centene benefit or previously met initial approval criteria; continuity of care rules apply if applicable; request must be for Sporanox or itraconazole capsules or oral solution; generic-first requirement applies unless contraindicated; dose increase requests must not exceed one of the following: a) Capsules: 400 mg (4 capsules) per day; b) Oral solution: 400 mg (40 mL) per day.max 400 mg/day typical

Approval duration: 12 months

Other diagnoses/indications

Other diagnoses/indications: 1) For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), follow the no-coverage policy for the relevant line of business (CP.CPA.190 commercial; HIM.PA.33 health insurance marketplace; CP PMN.255 Medicaid); OR 2) For drugs NOT on the formulary or PDL, follow the non‑formulary policy for the relevant line of business (CP.CPA.190 commercial; HIM.PA.103 health insurance marketplace; CP PMN.16 Medicaid); if the requested use is not listed elsewhere and criterion 1/2 do not apply, follow the off‑label use policy for the relevant line of business (CPCPA.09 commercial; HIM.PA.154 marketplace; CP.PMN.53 Medicaid).n/a

References to applicable policies for formulary, non-formulary, and off-label determinations

Tolsura capsules are not indicated for the treatment of onychomycosis and are not interchangeable or substitutable with other itraconazole products. This distinction is based on product-specific indications and labeling and should be considered when evaluating requests for onychomycosis therapy.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (for example, CPCPA.09 for commercial and HIM.PA.154 for health insurance marketplace). Requests for such off‑label uses will be adjudicated only when supporting clinical evidence meeting those policy standards is provided.

Itraconazole is contraindicated in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. This contraindication is specifically called out for certain uses (for example, treatment of onychomycosis with Sporano x capsules) and is included as a boxed warning in the product labeling; avoid use in these patients unless treating life‑threatening infections where benefits outweigh risks and product labeling permits.

Use of itraconazole for indications not covered by this policy without adequate supporting documentation per the referenced off‑label use policies is considered not authorized / not medically necessary. Providers must follow the applicable off‑label and formulary/non‑formulary policies and submit clinical justification and evidence as required for consideration.

Billing, Dosing Limits and Codes

No specific billing codes listedmixed

No codes listed

Maximum daily doses

Typical capsule capItraconazole capsules (including Sporanox) generally limited to 400 mg/day (4 capsules)

Tolsura capsule capTolsura capsules typically limited to 260 mg/day (4 capsules)

Onychomycosis dosing capFor onychomycosis approval criteria specify dose must not exceed 400 mg/day

Maximum daily dose — formulation & indication

Common maximum doseCommon maximum dosing for itraconazole capsules and many indications is 400 mg/day (4 capsules)

High-severity maximumFor severe or life‑threatening infections (e.g., disseminated coccidioidomycosis, life‑threatening sporotrichosis) capsules/oral solution may be dosed up to 600 mg/day initially per indication-specific guidance

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required and approval is granted only when the listed criteria for the specific diagnosis/indication are met. 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 sufficient documentation may result in denial or delay of the request.

Documentation must include relevant clinical notes, prior medication trials (dates, doses, responses, and adverse effects), and any specialty consultation notes when required (infectious disease, pulmonology, or HIV specialist).
For continuation or dose-increase requests, include evidence of prior authorization or prior benefit use when applicable (continuity of care situations).

Step Therapy

Step / Failed Therapy Requirements

Providers must document trials of preferred therapies and failures or contraindications as specified for the requested indication. Step/failed therapy requirements apply unless contraindicated, clinically significant adverse effects occur, or prohibited by state-specific regulations (e.g., Illinois HB 5395 for HIM requests effective 1/1/2026).

Background

Itraconazole is an azole antifungal agent available in multiple formulations (including Sporanox capsules and oral solution, Tolsura capsules, and generic itraconazole products) with FDA‑approved indications that include treatment of invasive fungal infections such as blastomycosis and histoplasmosis, and use in aspergillosis when patients are intolerant of or refractory to alternative therapy. Sporanox oral solution is indicated for oropharyngeal and esophageal candidiasis, and Sporanox capsules are indicated for onychomycosis. Notably, Tolsura is not indicated for onychomycosis and is not interchangeable with other itraconazole products; clinicians should confirm the specific formulation and indication when requesting prior authorization.

Definitions and Product Notes

Itraconazole products

Included productsSporanox (capsules, oral solution), Tolsura (capsules), and generic itraconazole capsules and oral solution are covered formulations

Tolsura indication noteTolsura is not indicated for onychomycosis and is not interchangeable/substitutable with other itraconazole products

Formulation-specific usesSporanox oral solution indicated for oropharyngeal and esophageal candidiasis; capsules indicated for onychomycosis and systemic mycoses

Contraindication: Congestive heart failure (CHF)

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

Onychomycosis-specific restriction

OpenPayer

Clinical Policy: Itraconazole (Sporanox, Tolsura)

Coverage Criteria for Itraconazole

Billing, Dosing Limits and Codes

Provider Actions and Prior Authorization

Background

Definitions and Product Notes