CurrentMass General Brigham Health PlanPolicy N/A

Rezzayo (rezafungin) prior authorization and coverage

Defines prior authorization, coverage criteria, quantity limits, and specialty routing for rezafungin (Rezzayo) for adults with candidemia or invasive candidiasis under Mass General Brigham Health Plan and MassHealth UPPL; applies to pharmacy and medical benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRezzayo (rezafungin) prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document infectious disease specialist involvement plus failure/intolerance/contraindication or resistance to all three echinocandins.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 monthsmaximum approval duration

<6requested quantity limit per course

>=18patient age population

Pharmacy & Medicalapplicability across benefits

Coverage Criteria for Rezzayo (rezafungin)

Policy Summary

PayerMass General Brigham Health Plan

PolicyRezzayo (rezafungin) prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document infectious disease specialist involvement plus failure/intolerance/contraindication or resistance to all three echinocandins.

SourceLink

On This Page

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Initial therapy / Authorization criteria

Authorization may be granted when ALL of the following are met:

Rezzayo coverage criteria: Diagnosis of candidemia OR invasive candidiasis

Age requirement: Member is >= 18 years of age

Prescriber requirement: Prescriber is an infectious disease specialist OR consult notes from an infectious disease specialist are provided

Failed/Intolerant/Resistant to echinocandins

Anidulafungin
Caspofungin
Micafungin

Quantity limit: Requested quantity is less than 6 vials for one course of therapy<6 vials

Requests for members who are new to the plan and are currently receiving Rezzayo (rezafungin) may be reviewed on a case-by-case basis. This case-by-case review does not apply when the product was obtained as samples or through a manufacturer's patient assistance program; products supplied by those means are excluded from case-by-case consideration.

If the authorization criteria are not met, the request should be denied as not meeting medical necessity. Examples include: patient age <18 years; no documented inadequate response, adverse reaction, contraindication, or Candida isolate resistance to all three echinocandins (anidulafungin, caspofungin, micafungin); prescriber is not an infectious disease specialist and no specialist consult notes are provided; or the requested quantity is >=6 vials for a single course of therapy.

Coding and Quantity Limits

No explicit billing codes listedmixed

No codes listed

Quantity limits

Maximum vials per courseRequested quantity is <6 vials for one course of therapy

Maximum approval durationUp to 2 months (policy maximum approval duration)

Applicability across benefitsQuantity limit applies to both pharmacy and medical benefits as specified in the policy scope

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rezzayo (rezafungin) on both the pharmacy and medical benefits. Requests will be reviewed on a case-by-case basis for members who are new to the plan and currently receiving the medication (exclusion: products obtained only as samples or through manufacturer patient assistance programs).

Applies to pharmacy and medical benefits
Case‑by‑case review permitted for members new to plan who are currently receiving medication (excluding samples or manufacturer assistance)

Step Therapy

Step Therapy — Failed Alternatives Required

Authorization will be considered only after failure, intolerance, contraindication, or documented resistance to ALL three echinocandins. The prescriber must document prior use and the reason for failure/intolerance/contraindication/resistance for each agent.

Required failure/intolerance/contraindication/resistance to: anidulafungin; caspofungin; micafungin

Documentation Required

Specialist Prescriber or Consult Required

The requesting prescriber must be an infectious disease specialist. If the prescriber is not an infectious disease specialist, include consult notes from an infectious disease specialist with the request to support medical necessity.

Prescriber = infectious disease specialist OR include infectious disease specialist consult notes

Denial Risk

Denial Triggers and Risks

Denial is likely if the member is not new to the plan and is not currently receiving the medication, unless the medication was obtained as samples or via the manufacturer's patient assistance program. Requests that do not meet the step‑therapy requirement, lack specialist documentation, or exceed the requested quantity limit (<6 vials per course) may be denied.

Denial risk when member not new to plan and not currently on medication (unless samples/manufacturer assistance)
Denial risk for missing step‑therapy documentation or lack of infectious disease specialist support
Requested quantity must be <6 vials for one course of therapy

Definitions

Candidemia / Invasive candidiasis

DefinitionCandidemia and invasive candidiasis: bloodstream and invasive fungal infections caused by Candida species requiring systemic antifungal therapy

Clinical scopeIncludes candidemia (bloodstream infection) and other invasive Candida infections requiring systemic treatment

Treatment implicationPatients must receive systemic antifungal therapy; policy applies to adult patients (>=18 years) receiving rezafungin when criteria met

Prescriber requirementPrescriber must be an infectious disease specialist or provide consult notes from a specialist to support use for these infections

Background

Rezzayo (rezafungin) is a long-acting echinocandin antifungal agent indicated for treatment of candidemia and invasive candidiasis in adult patients. The policy frames use for adults with candidemia or invasive candidiasis who have limited or no alternative treatment options and requires documentation of inadequate response, intolerance, contraindication, or isolate resistance to other echinocandins prior to authorization.