CurrentAvMedPolicy N/A

Rezzayo (rezafungin) prior authorization for IV (J0349)

This prior authorization/step-edit form outlines clinical criteria, dosing limits, documentation requirements, and billing details for Rezzayo (rezafungin) administered intravenously (HCPCS J0349/NDC 70842-0240-01) for AvMed members. It governs approval requirements for adults with candidemia or invasive candidiasis when prescribed by or in consultation with an infectious disease specialist.

Policy Summary

PayerAvMed

PolicyRezzayo (rezafungin) prior authorization for IV (J0349)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and print name on form and fax complete member/prescriber/drug information to 1-877-535-1391; provide documentation of systemic infection signs, mycological evidence from blood or sterile site, and medication treatment history showing failure to one recommended agent or resistance evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this update.

6Max vials per course

1200Max billable units

18+Minimum member age (years)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: This prior authorization applies to Rezzayo (rezafungin) IV (HCPCS J0349 / NDC 70842-0240-01) for adults with candidemia or invasive candidiasis. Subject: Rezzayo (rezafungin) prior authorization for IV (J0349). Intended population: adults (aged 18 years or older) with documented candidemia or invasive candidiasis. Specialist involvement: must be prescribed by or in consultation with an infectious disease specialist and appropriate clinical and microbiological documentation must be provided.

Initial Authorization / Medical Necessity Criteria

Medically Necessary / Initial Authorization Criteria

All criteria below must be met for approval. To support each line checked, documentation (labs, diagnostics, chart notes) must be provided.

ALL of the following

Member is 18 years old or older
Prescribed by or in consultation with an infectious disease specialist
Provider has submitted documentation recording systemic signs of infections caused by candidemia or invasive candidiasis (e.g., fever, hypothermia, hypotension, tachycardia, or tachypnea)
Provider has submitted documentation of mycological evidence from a blood sample or a normally sterile site showing a Candida species causing candidemia or invasive candidiasis
Member does NOT have severe hepatic impairment with a history of chronic cirrhosis (Child-Pugh score > 9)
Exclusion if Child-Pugh score > 9
Member does NOT have endocarditis, osteomyelitis, meningitis, septic arthritis, chorioretinitis, chronic disseminated candidiasis, or urinary tract infection due to a Candida species
These specific infection types are excluded from this approval pathway
Treatment history requirement
- Member has a medication treatment history showing failure to ONE of the following along with documentation of clinical status demonstrating limited or no alternative options for the treatment of candidemia and invasive candidiasis
- ONE of
  - Trial of ONE echinocandin (unless susceptibility panel documents resistance): caspofungin with a loading dose 70 mg, then 50 mg daily; micafungin 100 mg daily; or anidulafungin with a loading dose 200 mg then 100 mg daily for the appropriate length of therapy, or until progressing growth of Candida species observed
    Susceptibility panel documenting resistance is an exception to the trial requirement
  - Fluconazole, intravenous or oral, 800 mg (12 mg/kg) loading dose, then 400 mg (6 mg/kg) daily for the appropriate length of therapy, or until progressing growth of Candida species observed

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title": "Medically Necessary / Initial Authorization Criteria

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Continuation / Quantity Limits

Billing Rule

Dosing and quantity limits

Max 2 vials for loading dose and 4 vials for four weekly maintenance doses (total 6 vials per treatment course). 1200 maximum billable units. Max units per treatment course = 6 vials.

Continuation approvals follow the same clinical criteria and documentation requirements as initial authorization: all clinical criteria must be met and supporting documentation (labs, diagnostics, chart notes) must be submitted. Quantity/dosing limits apply to the full treatment course: the policy specifies a maximum of 6 vials per treatment course (2 vials for the loading dose and 4 vials for four weekly maintenance doses) totaling 1200 maximum billable units.

Exclusions / Denial Conditions

Exclusion / Denial Criteria

Exclusion/Denial criteria

Member has severe hepatic impairment with a history of chronic cirrhosis (Child-Pugh score > 9)
Requests will be denied if member has severe hepatic impairment with chronic cirrhosis (Child-Pugh > 9).
Member has endocarditis, osteomyelitis, meningitis, septic arthritis, chorioretinitis, chronic disseminated candidiasis, or urinary tract infection due to a Candida species
Requests will be denied if member has any of these specified infection types.

ref": "b3_0

title":

ref_orig":

Denial Risk

Exclusion criteria risk

Requests will be denied if the member has severe hepatic impairment with chronic cirrhosis (Child-Pugh score > 9) or if the member has any of the specified excluded infection types: endocarditis, osteomyelitis, meningitis, septic arthritis, chorioretinitis, chronic disseminated candidiasis, or urinary tract infection due to a Candida species.

Provider Actions & Documentation Requirements

Prior Authorization

Submit prior authorization request

Prescribing physician must sign and clearly print name on the prior authorization request form (preprinted stamps not valid). Fax the completed form to 1-877-535-1391. Ensure all required member, prescriber, and drug information is provided; incomplete, incorrect, or illegible information may delay authorization.

Documentation Required

Provide clinical and microbiological documentation

Submit documentation of systemic signs of infection (e.g., fever, hypothermia, hypotension, tachycardia, or tachypnea), and mycological evidence from a blood sample or a normally sterile site showing a Candida species causing candidemia or invasive candidiasis. Also provide medication treatment history showing failure to one prior recommended agent (trial of one echinocandin or high‑dose fluconazole) or laboratory susceptibility evidence of resistance.

Prior Authorization

Specialist requirement

Prescriber must be an infectious disease specialist or consult with an infectious disease specialist for approval.

Background

Form-based medical prior authorization for Rezzayo (rezafungin) ensures appropriate use for candidemia and invasive candidiasis in adults. Requests must be completed on the prescribing form, signed by the prescribing physician, and faxed to the number on the form. Approval requires specialist involvement (prescribed by or in consultation with an infectious disease specialist) and microbiological confirmation (mycological evidence from blood or a normally sterile site). Prior therapy requirement: documentation must show trial and failure of at least one echinocandin (unless susceptibility testing documents resistance) or high‑dose fluconazole (800 mg IV/oral loading then 400 mg daily) before approval unless resistance is documented.