CurrentMass General Brigham Health PlanPolicy N/A

Rezzayo (rezafungin)

Prior authorization and coverage criteria for Rezzayo (rezafungin) for treatment of candidemia and invasive candidiasis in adults under Mass General Brigham Health Plan; includes age, diagnosis, prior therapy, and initial approval duration.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRezzayo (rezafungin)

Policy CodePolicy N/A

Change TypeClarified (policy created/reviewed)

Effective DateMar 1, 2024

Next Review Date

Key ActionPrior authorization required; approve only if criteria are met (age ≥18, invasive candidiasis with limited/no alternatives, and trial/failure/intolerance/contraindication to caspofungin or micafungin).

SourceLink

POLICY UPDATE CHANGES

Policy created and reviewed 2/14/2023, effective 3/1/2024.

5Initial Approval Duration (weeks)

18+Minimum Age (years)

2Required Prior Agents (options)

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Prior authorization and coverage criteria for Rezzayo (rezafungin) for the treatment of candidemia and invasive candidiasis in adults under Mass General Brigham Health Plan. Authorization requires the member to be 18 years or older, have a diagnosis of invasive candidiasis with limited or no alternative options, documentation of trial and failure, intolerance, or contraindication to at least one echinocandin (caspofungin or micafungin), and initial approvals are limited to 5 weeks.

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Initial Therapy Criteria

Prior Authorization

Prior authorization required

Approval is granted only if all authorization criteria are met: member is ≥18 years old, has invasive candidiasis with limited or no alternative options, and has had trial and failure, intolerance, or contraindication to an echinocandin (caspofungin or micafungin). Prior authorization is required before coverage.

Billing Rule

Initial approval duration

Initial approvals will be granted for 5 weeks.

Continuation / New-to-Plan Criteria

Documentation Required

Document prior antifungal trials

Provider must document trial and failure, intolerance, or contraindication to at least one echinocandin agent (caspofungin or micafungin) and that the member has limited or no alternative treatment options.

Limitations / Unstudied Conditions

Background/limitations: Approval was granted based on limited clinical safety and efficacy data. Rezzayo was not studied in Candida endocarditis, osteomyelitis, or meningitis — these are important exclusions/limitations to consider in clinical decision-making.

Applicable Codes

DrugNDCCovered

No codes listed

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required. Authorization may be granted only when all criteria are met: member is 18 years of age or older; member has a diagnosis of invasive candidiasis with limited or no alternative options; and the member has had trial and failure, intolerance, or contraindication to one of the following echinocandins: caspofungin or micafungin.

Documentation Required

Document prior antifungal trials

Required documentation includes evidence that the member tried and had trial failure, intolerance, or a contraindication to an echinocandin (caspofungin or micafungin) and documentation that the member has limited or no alternative treatment options for invasive candidiasis.

Billing Rule

Initial approval duration

Initial approvals will be granted for 5 weeks. (See policy limitations for renewal or continuation criteria.)

Clinical Evidence

Evidence: Rezzayo Prescribing Information: Melinta Therapeutics LLC; June 2023. Approval is based on limited clinical safety and efficacy data as noted in the background and product labeling.

Limited or no alternative optionsClinical judgment that other standard antifungal therapies are unsuitable due to failure, intolerance, contraindication, or other patient-specific factors.

Background

Rezzayo is indicated for adults aged 18 years and older with candidemia and invasive candidiasis who have limited or no alternative treatment options. Data supporting this indication are limited, and the medication has not been studied in Candida endocarditis, osteomyelitis, or meningitis.

Revision History

2023-02-14Created/Reviewed

Policy created and reviewed 2/14/2023 during Feb P&T; effective date 03/01/2024. Document indicates creation and review; no clinical policy statement changes (not material).