mhn Itraconazole Coverage Prior Auth Policy

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: (a) fingernail disease: failure of a 6-week trial of oral terbinafine 250 mg/day unless contraindicated or clinically significant adverse effects are experienced; (b) toenail disease: failure of a 12-week trial of oral terbinafine 250 mg/day unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 400 mg (4 capsules) per day.Dose does not exceed 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 clinically significant adverse effects are experienced; 5. Failure of a 7-day trial of fluconazole unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed 200 mg (20 mL) per day.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 clinically significant adverse effects are experienced; 5. Dose does not exceed 200 mg (20 mL) per day.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 clinically significant adverse effects are experienced; 5. Dose does not exceed one of the following: (a) itraconazole/Sporanox capsules 400 mg (4 capsules) per day; or (b) Tolsura capsules 260 mg (4 capsules) per day.400 mg/day or 260 mg/day

Prior authorization may be required for voriconazole

Initial Therapy — Blastomycosis or Histoplasmosis

Covered when ALL of the following are met

Blastomycosis/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/Sporanox capsules 400 mg (4 capsules) per day; or (b) Tolsura capsules 260 mg (4 capsules) per day.400 mg/day or 260 mg/day

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 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 clinically significant adverse effects are experienced; 4. Dose does not exceed one of the following: (a) itraconazole/Sporanox capsules 400 mg (4 capsules) per day; (b) itraconazole/Sporanox oral solution 200 mg (20 mL) per day; or (c) Tolsura capsules 260 mg (4 capsules) per day.see text

Initial Therapy — Coccidioidomycosis (off-label)

Covered when ALL of the following are met

Coccidioidomycosis initial: 1. Diagnosis of coccidioidomycosis with 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 formulations unless contraindicated or clinically significant adverse effects are experienced; 5. Failure of fluconazole at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed one of the following depending on scenario: capsules 400–600 mg/day or oral solution 400–600 mg/day as specified by disease presentation and HIV status.400–600 mg/day depending on scenario

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 systemic); 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 formulations unless contraindicated or clinically significant adverse effects are experienced; 5. For severe pulmonary/meningeal/disseminated disease: previous use of amphotericin B unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed: capsules 400 mg (4 capsules) per day or oral solution 400 mg (40 mL) per day.400 mg/day

Initial Therapy — Other diagnoses/indications

Covered when ONE of the following is met

Other uses: 1. If the drug has had a label change within the last 6 months not yet reflected in this policy, follow the referenced formulary/non‑formulary policies for the relevant line of business; OR 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, HIM.PA.154, CP.PMN.53).

References to other payer policies for processing

Continued Therapy (by indication)

Covered when ALL of the following are met for each indication

Onychomycosis continuation: 1. Member is currently receiving medication via Centene benefit or has previously met initial approval criteria OR is enrolled in a continuity of care program; 2. Member is responding positively to therapy; 3. Request is for Sporanox oral capsules or itraconazole capsules; 4. If brand requested, 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; 400 mg/day

Approval duration: Fingernail up to 2 months total; Toenail up to 3 months total

Oropharyngeal/Esophageal continuation: 1. Member is currently receiving medication via Centene benefit or has previously met initial approval criteria OR is enrolled in a continuity of care program; 2. Member is responding positively to therapy; 3. Request is for Sporanox oral solution or itraconazole oral solution; 4. If brand requested, 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.200 mg/day

Hematologic Malignancy (off-label)

Hematologic Malignancy (off-label) — approval 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, or (b) currently receiving medication and 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) per day; (b) itraconazole/Sporanox oral solution 200 mg (20 mL) per day; or (c) Tolsura capsules 260 mg (4 capsules) per day.Approval duration: 6 months

Continuity of care references: state addendums CC.PHARM.03A/03B

Coccidioidomycosis (off-label)

Coccidioidomycosis (off-label) — approval 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, or (b) currently receiving medication and 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. If request is for a dose increase, new dose does not exceed: (a) for disseminated extrathoracic nonmeningeal or meningeal disease: capsules 600 mg (6 capsules) per day or oral solution 600 mg (60 mL) per day; (b) for all other coccidioidomycosis infections: capsules 400 mg (4 capsules) per day or oral solution 400 mg (40 mL) per day.Approval duration: 12 months

HIV-specific loading dosing for first 3 days noted in dosing section

Sporotrichosis (off-label)

Sporotrichosis (off-label) — approval 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, or (b) currently receiving medication and 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 request is for a dose increase, new dose does not exceed: (a) capsules 400 mg (4 capsules) per day; or (b) oral solution 400 mg (40 mL) per day.Approval duration: 12 months

For severe disease prior amphotericin B is required per initial criteria

Other diagnoses/indications (continuation)

Other diagnoses/indications:

Other indications pathway: 1. If a recent label change within the last 6 months is not reflected in this policy, follow the referenced formulary/non‑formulary policies for the relevant line of business; OR 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, HIM.PA.154, CP.PMN.53).See referenced policies for evaluation

Provides routing for uses not specifically enumerated

Dosage and Administration (FDA labeled)

FDA‑labeled dosing and administration (coverage-aligned dosing limits):

Dosage limits by formulation and indication: Detailed dosing regimens by indication are provided in section V. Common maximums include: capsules 400 mg/day for many indications (up to 600 mg/day for severe coccidioidomycosis or life‑threatening situations); oral solution maxima typically 200 mg/day for oropharyngeal/esophageal uses and up to 600 mg/day for severe infections; Tolsura dosing typically 130 mg PO daily with maximum 260 mg/day (higher loading regimens described for life‑threatening situations).

Refer to section V for indication‑specific regimens and loading schedules

Tolsura is not indicated for the treatment of onychomycosis and is not interchangeable or substitutable with other itraconazole products. Requests for onychomycosis should be for Sporanox (itraconazole) capsules or generic itraconazole capsules per the coverage criteria.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the request is supported by sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid) or by an applicable evidence of coverage document.

Uses that are non‑FDA approved and not addressed by this policy — and not supported by the referenced off‑label policies or evidence of coverage documentation — may be determined to be not medically necessary and therefore not covered.

Coding and Dose Limits

Referenced comparator/step therapy agentsmixed

voriconazole

Referenced as step therapy agent — prior authorization may be required

No specific CPT/ICD/NDC codes listed in this part of the documentmixed

No codes listed

Dose limits by formulation/indication — inv-21

Onychomycosis (Sporanox/itraconazole capsules)Maximum 400 mg/day (4 capsules); fingernail approval duration 2 months, toenail 3 months.

Aspergillosis (capsules vs Tolsura)Itraconazole/Sporanox capsules: max 400 mg/day (4 capsules); Tolsura capsules: max 260 mg/day (4 capsules).

Blastomycosis / HistoplasmosisItraconazole/Sporanox capsules: max 400 mg/day; Tolsura capsules: max 260 mg/day.

Hematologic malignancy (prophylaxis)Capsules: max 400 mg/day; Oral solution: max 200 mg/day (20 mL); Tolsura: max 260 mg/day.

Coccidioidomycosis (severity-dependent)Capsules/oral solution: 400–600 mg/day depending on presentation (e.g., disseminated/meningeal up to 600 mg/day; HIV co-infection initial loading then 400 mg/day).

Sporotrichosis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required and approval is contingent on meeting the specific initial or continuation criteria for the requested indication. Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

Prior authorization required for all indications described in this policy.
Failure to submit supporting documentation may result in denial.

Documentation Required

Required Clinical Documentation

Provider must submit documentation (such as office chart notes, laboratory results, medication history, and other clinical information) supporting that the member meets all approval criteria. Failure to provide sufficient documentation may result in a denial of the prior authorization request.

Examples of acceptable documentation: recent office visit notes, diagnostic test results, culture or pathology reports, prior medication trial dates and dosages, and specialist consultation notes.

Background

Itraconazole is an azole antifungal indicated for a range of fungal infections. Sporanox capsules are indicated for onychomycosis of the toenail and fingernail due to dermatophytes, while Sporanox oral solution is indicated for oropharyngeal and esophageal candidiasis. The policy also addresses use of itraconazole (Sporanox, Tolsura, and generics) for other fungal infections and certain off‑label indications with specified criteria.

Definitions and Important Safety Information

Itraconazole formulations — inv-32

Included products (brand and generic)Sporanox (capsules and oral solution) and generic itraconazole (capsules and oral solution) are referenced throughout the policy.

Tolsura (capsules)Tolsura capsules are listed separately with distinct dosing limits and are included as an itraconazole formulation in the policy.

Tolsura not for onychomycosisTolsura is not indicated for the treatment of onychomycosis and is not interchangeable or substitutable with other itraconazole products.

Product-specific dosing referencedDosage and administration tables specify formulation-specific regimens and maxima for Sporano x, oral solution, and Tolsura (see section V dosing tables).

Contraindication for CHF — inv-33

CHF contraindication (general)

OpenPayer

Clinical Policy: Itraconazole (Sporanox, Tolsura)

Coverage Criteria for Itraconazole

Coding and Dose Limits

Provider Actions, Prior Authorization, and Documentation

Background

Definitions and Important Safety Information