CurrentCentenePolicy CP.PMN.154

Isavuconazonium (Cresemba)

Defines medical necessity criteria, dosing, age/weight limits, step therapy and continuation requirements, contraindications, therapeutic alternatives, HCPCS coding, and product availability for Cresemba for commercial, HIM and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyIsavuconazonium (Cresemba)

Policy CodePolicy CP.PMN.154

Change TypeClarified; Coding added; Pediatric expansion (historical)

Effective Date11.16.16

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Clarified statement for 'Request is for injection for nasogastric tube administration, or capsules'.

Added HCPCS code J1833 to coding implications.

Revised to reflect pediatric expansion for both indications and clarified voriconazole trial applicability.

2FDA approved indications

372 mg/dayMaximum maintenance dose

J1833HCPCS code added

Age ≥1, ≥6Age thresholds (IV vs oral/NG)

Coverage Summary

Policy status: covered_with_criteria. The policy covers isavuconazonium (Cresemba) for the FDA-approved indications of invasive aspergillosis and invasive mucormycosis when all specified criteria are met. Key criteria include specialist prescribing/consultation requirements (infectious disease specialist, oncologist, or transplant specialist for aspergillosis), age and route-specific minimums (IV: age ≥ 1 year; capsules/NG: age ≥ 6 years and weight ≥ 16 kg), step therapy requirements with voriconazole and/or posaconazole where indicated, and dosing limits (loading regimen and a maximum maintenance dose of 372 mg/day). Continued coverage requires prior approval criteria or current receipt of therapy and positive response, with dose increases not exceeding the same maintenance limits.

Threshold summary

Injection age minimum (IV)≥ 1 year

Capsules/NG tube age minimum≥ 6 years

Weight minimum for capsules/NG tube≥ 16 kg

Maximum maintenance dose372 mg/day

Loading regimen total doses372 mg every 8 hours for 48 hours (total 6 doses)

Initial Therapy Criteria — Invasive Aspergillosis

Initial Approval Criteria - Aspergillosis

Covered when ALL of the following are met:

ALL of the following

Diagnosis of invasive aspergillosis
Prescribed by or in consultation with an infectious disease specialist, oncologist, or transplant specialist
Age/formulation
- Request is for injection for intravenous administration: Age ≥ 1 year
- Request is for injection for nasogastric tube administration, or capsules, both of the following: Age ≥ 6 years; Body weight ≥ 16 kg

Initial Therapy Criteria — Invasive Mucormycosis

Step Therapy

Posaconazole step requirement for mucormycosis

For invasive mucormycosis, failure of posaconazole (tablet or IV) is required prior to coverage unless posaconazole is contraindicated, the member experienced clinically significant adverse effects (intolerant), or susceptibility testing demonstrates the pathogen is not susceptible to posaconazole. (IL HIM bypass for step therapy applies per IL HB 5395.)

Prior Authorization

Specialist prescriber requirement (mucormycosis)

Initial requests for mucormycosis must be prescribed by or in consultation with an infectious disease specialist.

Continuation / Renewal Criteria

Documentation Required

Submit supporting documentation

Provider must submit documentation (office notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

Billing Rule

Dose limit enforcement

Requests exceeding the maximum maintenance dose of 372 mg/day will not meet criteria. Affected HCPCS code: J1833 (injection, isavuconazonium, 1 mg).

Other / Off‑Label Indications

Diagnoses/Indications Not Authorized

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation per off-label use policies or evidence of coverage documents is provided

Non-FDA approved indications not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per the applicable off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documents as required by the policy.

Applicable Codes

Drug HCPCS code (informational)HCPCS

J1833

Injection, isavuconazonium, 1 mg

Note: A HCPCS code J1833 (Injection, isavuconazonium, 1 mg) was added in 2Q 2024 and is included for informational/billing purposes; coding inclusion does not guarantee coverage and providers should reference current coding guidance.

Provider Actions & Requirements

Documentation Required

Submit supporting documentation

Provider must submit documentation (office notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

Prior Authorization

Specialist prescriber requirement

Initial requests must be prescribed by or in consultation with an infectious disease specialist, oncologist, or transplant specialist.

Step Therapy

Clinical Evidence & References

Evidence sources: Primary source is the Cresemba Prescribing Information, Astellas, December 2023. Guideline sources include the IDSA practice guidelines for aspergillosis and the ECIL-6 guideline(s) cited for invasive fungal disease management. The policy background and criteria are aligned to these FDA indications and guideline recommendations.

Background

Background/summary: Isavuconazonium (Cresemba) is an azole antifungal indicated for invasive aspergillosis and invasive mucormycosis. The policy aligns coverage to FDA indications including pediatric expansions (injection indicated for patients ≥ 1 year; capsules/NG administration indicated for patients ≥ 6 years and ≥ 16 kg) and specifies a step therapy approach requiring trial or contraindication/intolerance to voriconazole for many aspergillosis patients and failure of posaconazole for mucormycosis unless contraindicated or non-susceptible. Dosing follows the FDA regimen with a loading series (372 mg every 8 hours for 48 hours, total 6 doses) and maintenance dosing not to exceed 372 mg/day.

Definitions

HIMHealth Insurance Marketplace (line of business referenced)

Revision History

12.14.23pediatric_expansion

RT4 revision to reflect pediatric expansion for both indications and clarified that the required trial of voriconazole for invasive aspergillosis only applies to age ≥ 2 years; Appendix B dosing regimens updated per voriconazole's package insert.

2Q 2024coding_added

2Q 2024 annual review added HCPCS code J1833 (Injection, isavuconazonium, 1 mg) to coding implications.

2Q 2025clarifiedLatest

2Q 2025 annual review clarified the statement 'Request is for injection for nasogastric tube administration, or capsules' and added a step therapy bypass for Illinois HIM per IL HB 5395.

Policy Summary

PayerCentene

PolicyIsavuconazonium (Cresemba)

Policy CodePolicy CP.PMN.154

Change TypeClarified; Coding added; Pediatric expansion (historical)

Effective Date11.16.16

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Step therapy / prior use of voriconazole/posaconazole

Member is age ≥ 2 years and use of voriconazole is contraindicated or member previously experienced clinically significant adverse effects to voriconazole
Member is age ≥ 2 years and < 13 years and had prior inadequate response (i.e., refractory or progressive aspergillosis) to voriconazole
Member is age ≥ 13 years and had prior inadequate response (i.e., refractory or progressive aspergillosis) to voriconazole: Failure of posaconazole at up to maximally indicated doses, unless contraindicated, clinically significant adverse effects are experienced, or susceptibility testing demonstrates that the pathogen is not susceptible to posaconazole
For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395.

Dose limits

Adults (age ≥ 18 years)
- Loading dose: 372 mg every 8 hours for 48 hours (total 6 doses)
- Maintenance dose: 372 mg per day
Pediatrics (age < 18 years): age- and weight-based loading and maintenance dose in section V, up to a maximum of 372 mg per day

Prior Authorization

Specialist prescriber requirement

Initial requests must be prescribed by or in consultation with an infectious disease specialist, oncologist, or transplant specialist.

Step Therapy

Step therapy with voriconazole/posaconazole

Step therapy: Trial of voriconazole is required unless contraindicated or clinically significant adverse effects occurred (age-specific exceptions apply). For members ≥ 2 years, voriconazole contraindication or intolerance satisfies step. For members 2 to <13 years, prior inadequate response to voriconazole satisfies step. For members ≥13 years, prior inadequate response to voriconazole PLUS failure of posaconazole at maximally indicated doses is required unless contraindicated, adverse effects occur, or susceptibility testing shows resistance. For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Step therapy with voriconazole/posaconazole

Step therapy: For invasive aspergillosis, voriconazole trial is required for specified age groups (applies to patients age ≥ 2 years). For patients age ≥ 13 years with prior inadequate response to voriconazole, failure of posaconazole at up to maximally indicated doses is required unless contraindicated, intolerant, or susceptibility testing shows non-susceptibility. For mucormycosis, failure of posaconazole is required unless contraindicated, intolerant, or susceptibility testing shows non-susceptibility. Illinois HIM step therapy bypass applies per IL HB 5395.

Voriconazole trial applies to age ≥ 2 years for aspergillosis.
For age ≥ 13 years with prior inadequate response to voriconazole, require posaconazole failure unless exceptions apply.
For mucormycosis require failure of posaconazole unless contraindicated/intolerant or non-susceptible.
IL HIM: step therapy bypass per IL HB 5395.

Billing Rule

Dose limit enforcement

Requests exceeding the maximum maintenance dose of 372 mg/day will not meet criteria. HCPCS code included for reference: J1833 (Injection, isavuconazonium, 1 mg).