CurrentCentenePolicy CP.PMN.154

Isavuconazonium (Cresemba) coverage

Defines medical necessity, prior authorization, dosing, and coverage criteria for isavuconazonium (Cresemba) for treatment of invasive aspergillosis and invasive mucormycosis for Centene lines of business.

Policy Summary

PayerCentene

PolicyIsavuconazonium (Cresemba) coverage

Policy CodePolicy CP.PMN.154

Change TypeNo material change

Effective DateNov 16, 2016

Next Review Date

Key ActionPrior authorization required with documentation that approval criteria are met (diagnosis, prescriber specialty/consultation, age/weight limits, prior therapy/step requirements where applicable, and dosing within limits).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications covered

372 mg/dayAdult maintenance dose limit

≥1 yrMinimum age for IV

Step requiredPosaconazole step for mucormycosis

ILIL HIM carve-out

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Coverage Criteria for Isavuconazonium (Cresemba)

Initial Therapy - Aspergillosis

Covered when ALL of the following are met

Aspergillosis initial: 1. Diagnosis of invasive aspergillosis; 2. Prescribed by or in consultation with an infectious disease specialist, oncologist, or transplant specialist; 3. Age/administration limits: either (a) request for IV administration (injection for intravenous administration) with age ≥ 1 year OR (b) request for injection for nasogastric tube administration or oral capsules with both: age ≥ 6 years and body weight ≥ 16 kg; 4. One of the following: (a) member age ≥ 2 years and voriconazole is contraindicated or member previously experienced clinically significant adverse effects to voriconazole; (b) member age ≥ 2 years and < 13 years with prior inadequate response (refractory or progressive disease) to voriconazole; (c) member age ≥ 13 years with prior inadequate response to voriconazole AND failure of posaconazole at up to maximally indicated doses unless contraindicated, intolerant, or susceptibility testing demonstrates the pathogen is not susceptible to posaconazole; 5. Dose does not exceed dosing limits: adults (≥ 18 years) — loading dose 372 mg every 8 hours for 48 hours (total 6 doses) with maintenance 372 mg per day; pediatrics (< 18 years) — age- and weight-based loading and maintenance per section V, up to a maximum of 372 mg per day.see node text

Illinois HIM carve-out for step therapy applies per IL HB 5395

Initial Therapy - Mucormycosis

Covered when ALL of the following are met

Mucormycosis initial: 1. Diagnosis of invasive mucormycosis; 2. Prescribed by or in consultation with an infectious disease specialist; 3. Age/administration limits: either (a) request for IV administration (injection for intravenous administration) with age ≥ 1 year OR (b) request for injection for nasogastric tube administration or oral capsules with both: age ≥ 6 years and body weight ≥ 16 kg; 4. Failure of posaconazole tablet or IV unless contraindicated, clinically significant adverse effects are experienced, or susceptibility testing demonstrates the pathogen is not susceptible to posaconazole; 5. Dose does not exceed dosing limits: adults (≥ 18 years) — loading dose 372 mg every 8 hours for 48 hours (total 6 doses) with maintenance 372 mg per day; pediatrics (< 18 years) — age- and weight-based loading and maintenance per section V, up to a maximum of 372 mg per day.see node text

Illinois HIM carve-out for step therapy applies per IL HB 5395

Continuation Therapy

Covered when ALL of the following are met

Continuation: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member receiving medication and continuity of care regulations apply; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed: adults (≥ 18 years) — 372 mg per day; pediatrics (< 18 years) — age- and weight-based maintenance per section V, up to a maximum of 372 mg per day.see node text

Refer to state-specific continuity of care addendums as applicable.

Other indications / Off-label process

Other indications: If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow either the no-coverage criteria or non-formulary policy for the relevant line of business as specified (CP.CPA.190, HIM.PA.33, CP.PMN.255; or CP.CPA.190, HIM.PA.103, CP.PMN.16). 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: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53

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

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy. Refer to the applicable state Medicaid manual for specific coverage provisions that govern this medication.

Use of this medication for non‑FDA approved indications without adequate evidence or without following the off‑label use policies referenced in this document is not authorized (not medically necessary).

Product Codes, Age/Weight, and Dosing Information

Product availability / NDCsNDC

NDC not listed

Product availability: capsules 186 mg and 74.5 mg of isavuconazonium sulfate (equivalent to 100 mg and 40 mg of isavuconazole respectively); single-dose vial for injection 372 mg of isavuconazonium sulfate (equivalent to 200 mg of isavuconazole)

HCPCS Codes referencedHCPCS

J1833

Injection, isavuconazonium, 1 mg

Age and weight thresholds — dosing/administration

IV formulation age thresholdAge ≥ 1 year for intravenous administration

Capsule / NG administration thresholdsAge ≥ 6 years AND body weight ≥ 16 kg for capsules or nasogastric administration

Adult dosing definitionAdults defined as age ≥ 18 years (adult loading and maintenance dosing apply)

Maximum vial quantity per FDA labeling

Maximum vial quantityMaximum quantity per FDA labeling: 1 vial

Revision notePolicy revised max quantity from 2 vials to 1 vial per FDA labeling (2Q 2022 review)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation that all approval criteria are met and will be reviewed for medical necessity.

Prior authorization required with documentation that approval criteria are met
Failure to submit required documentation may result in denial

Documentation Required

Provider must submit supporting clinical documentation (for example, office chart notes, consultation notes, laboratory results, susceptibility testing, and other relevant clinical information) demonstrating that the member meets all applicable medical necessity criteria.

Examples: office notes, lab results, culture/susceptibility reports, prior medication trial documentation
Documentation should show prescriber specialty (infectious disease, oncology, or transplant specialist when required) and prior therapy attempts or contraindications

Background on Isavuconazonium (Cresemba)

Isavuconazonium (Cresemba) is an azole antifungal available as both an intravenous single‑dose vial and oral capsules. It is FDA‑approved for the treatment of invasive aspergillosis and invasive mucormycosis. IV and capsule formulations have age‑ and weight‑specific approvals: IV administration is approved for patients aged ≥1 year, while oral capsule or nasogastric administration is appropriate for patients aged ≥6 years who weigh at least 16 kg. Capsule strengths and single‑dose vial presentations are described in the product availability information and prescribing information.

Key Definitions and Therapeutic Alternatives

Isavuconazonium — definition

DefinitionIsavuconazonium (Cresemba) is an azole antifungal.

Indications (policy scope)Indicated in policy for treatment of invasive aspergillosis and invasive mucormycosis (IV and capsule formulations referenced)

Formulation contextAvailable as prodrug isavuconazonium sulfate with defined capsule and single-dose vial presentations (see product availability)

Therapeutic alternatives

Primary therapeutic alternative - voriconazoleVoriconazole is listed as a preferred alternative and suggested primary therapy for aspergillosis per clinical practice guidance in the policy appendices.

Therapeutic alternative - posaconazolePosaconazole is listed as an alternative (used for step therapy requirements in mucormycosis and as a subsequent option per policy criteria).