CurrentHealth NetPolicy CP PMN.154

Isavuconazonium (Cresemba) coverage

Policy governing medical necessity criteria, dosing, and coverage decisions for isavuconazonium (Cresemba) for treatment of invasive aspergillosis and invasive mucormycosis for Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyIsavuconazonium (Cresemba) coverage

Policy CodePolicy CP PMN.154

Change TypeNo material changes

Effective DateNov 16, 2016

Next Review DateMay 25, 2025

Key ActionPrior authorization is required with documentation that initial approval criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications listed

6 monthsapproval duration for continued therapy

372 mgdaily maintenance dose (adult)

J1833HCPCS code referenced

NCapplicable state

Coverage Criteria for Isavuconazonium (Cresemba)

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Initial Approval — Invasive Aspergillosis

Covered when ALL of the following are met:

Initial IA criteria: 1. Diagnosis of invasive aspergillosis;

Prescriber/consult: 2. Prescribed by or in consultation with an infectious disease specialist, oncologist, or transplant specialist;

Age and formulation-specific requirements: 3. Formulation and age requirements: request for IV injection: age >= 1 year; request for nasogastric tube administration or capsules: age >= 6 years and (when specified) body weight >= 16 kg as applicable;

Step therapy requirement: 4. For patients age >= 2 years, documented failure of voriconazole at up to maximally indicated doses unless voriconazole is contraindicated or clinically significant adverse effects occurred (note: Illinois HIM requests are exempt from this step therapy requirement as of 1/1/2026 per IL HB 5395).

Dosing limits: 5. Requested dose does not exceed one of the following dosing regimens: a) Loading dose: 372 mg every 8 hours for 48 hours (total 6 doses); b) Maintenance dose for adults (age >= 18 years): 372 mg per day; c) Pediatric patients: age- and weight-based loading and maintenance per dosing table, up to a maximum of 372 mg per day.

Initial Approval — Invasive Mucormycosis

Covered when ALL of the following are met:

Initial mucormycosis criteria: 1. Diagnosis of invasive mucormycosis;

Prescriber/consult: 2. Prescribed by or in consultation with an infectious disease specialist;

Formulation and age requirements: 3. Formulation and age requirements: request for IV injection: age >= 1 year; request for nasogastric tube administration or capsules: age and weight criteria apply (e.g., body weight >= 16 kg where specified);

Dosing limits: 4. Requested dose does not exceed one of the following dosing regimens: a) Loading dose: 372 mg every 8 hours for 48 hours (total 6 doses); b) Maintenance dose for adults (age >= 18 years): 372 mg per day; c) Pediatric patients: age- and weight-based loading and maintenance per dosing table, up to a maximum of 372 mg per day.

Continued Therapy

Covered when ALL of the following are met:

Continued therapy: 1. Member is currently receiving medication via the Centene benefit or previously met initial approval criteria, or member is enrolled in a state/product with continuity of care provisions;

Clinical response: 2. Member is responding positively to therapy based on clinical documentation;

Dose change limits: 3. If request is for a dose increase, the new dose does not exceed: a) Adults (age >= 18 years): 372 mg per day; b) Pediatrics (age < 18 years): age- and weight-based maintenance dose up to a maximum of 372 mg per day.

Approval duration: 4. Approval duration for continued therapy: 6 months.

Other Diagnoses/Indications

Other uses: For uses not specified in this policy, follow the applicable formulary/non‑formulary or off‑label use policy for the member's line of business (for example: CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary policies; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non‑formulary; CP.CPA.09, HIM.PA.154, CP.PMN.53 for off‑label uses).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety per the applicable off‑label use policies. Refer to CP.CPA.09 for commercial lines, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid when requesting coverage for off‑label uses.

HCPCS and other codes shown in this policy are provided for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage; providers must reference current professional coding guidance and the member's plan coverage rules when submitting claims.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — documentation that initial approval criteria are met (diagnosis and specialty prescriber/consultation required). Requests for injection (IV or nasogastric) and capsule administration require prior authorization and prescriber specialty documentation.

Diagnosis must meet policy criteria (e.g., invasive aspergillosis or invasive mucormycosis).
Prescribed by or in consultation with an infectious disease specialist, oncologist, or transplant specialist as specified in criteria.

Note

Prior Authorization Note for Injection

Prior authorization note for injection: HCPCS code J1833 (isavuconazonium, injection) may be referenced and used in prior authorization and billing processes. Inclusion of a HCPCS code is informational and does not by itself guarantee coverage.

HCPCS: J1833 (isavuconazonium injection)

Step Therapy

Step Therapy / Prior Antifungal Failure

Step therapy requirement: For patients age ≥ 2 years, requests must document failure of voriconazole at maximally indicated doses unless voriconazole is contraindicated or clinically significant adverse effects are experienced. For Illinois HIM requests, the step therapy requirement does not apply per IL HB 5395 effective 01/01/2026 (jurisdictional exception).

Step therapy: failure of voriconazole required for age ≥ 2 years unless contraindicated or adverse effects.
Jurisdictional exception: Illinois HIM — step therapy bypass per IL HB 5395 effective 01/01/2026.

Documentation Required

Documentation Requirement

Required documentation: Providers must submit supporting clinical documentation with the prior authorization request (office chart notes, lab results, medication history, consultation notes) that demonstrates the member meets all approval criteria. Failure to submit adequate supporting documentation may result in denial of the request.

Include office notes, relevant laboratory results, medication trial history (including evidence of voriconazole trial or contraindication), and specialty consultation notes.
Failure to provide requested documentation may result in denial.

Background and Drug Information

Isavuconazonium (Cresemba) is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis. The product is available as a single‑dose vial for injection (each vial of isavuconazonium sulfate is equivalent to 200 mg of isavuconazole) and as capsules (equivalent to 100 mg and 40 mg isavuconazole).

Recommended dosing includes a loading regimen followed by daily maintenance dosing. For adults the loading regimen is 372 mg every 8 hours for 48 hours (total of six doses), followed by a maintenance dose of 372 mg once daily. Pediatric dosing is weight‑ and age‑based with specified maximums and should not exceed the adult maintenance dose of 372 mg/day when applicable.

Contraindications and important coadministration cautions include hypersensitivity to the product and avoidance of strong CYP3A4 inhibitors or inducers due to significant drug interaction risk. Clinicians should follow age‑ and formulation‑specific requirements (for example, IV administration age thresholds) and consult the full prescribing information for detailed pediatric dosing, contraindications, and monitoring guidance.

Definitions and Key Drug Details

Isavuconazonium (Cresemba) — definition

Drug classAzole antifungal.

Generic nameIsavuconazonium (Cresemba)

Indications (policy)Treatment of invasive aspergillosis and invasive mucormycosis (FDA‑approved).

Contraindicated coadministration (CYP3A4 interactions)

Contraindicated coadministration — strong CYP3A4 inhibitorsKetoconazole; high‑dose ritonavir (400 mg every 12 hours).

RationaleStrong inhibitors can significantly increase isavuconazole plasma concentrations; strong inducers can significantly decrease concentrations.

Product availability and strengths

Injection (single‑dose vial)372 mg isavuconazonium sulfate per vial (equivalent to 200 mg isavuconazole).

Capsule — 186 mg186 mg isavuconazonium sulfate capsule (equivalent to 100 mg isavuconazole).

Capsule — 74.5 mg74.5 mg isavuconazonium sulfate capsule (equivalent to 40 mg isavuconazole).

OpenPayer

Isavuconazonium (Cresemba) coverage

Coverage Criteria for Isavuconazonium (Cresemba)

Coding and Billing Considerations

Provider Requirements and Prior Authorization

Background and Drug Information

Definitions and Key Drug Details