CurrentNeighborhood Health Plan of Rhode IslandPolicy Vfend PA Policy 241-A UDR 01-2024

Vfend (voriconazole) prior authorization criteria

Defines prior authorization requirements for voriconazole (Vfend) for treatment and prophylaxis of specified invasive and deep fungal infections for providers submitting requests to the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVfend (voriconazole) prior authorization criteria

Policy CodePolicy Vfend PA Policy 241-A UDR 01-2024

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation showing the request meets indication‑specific criteria and required prior therapy or intolerance evidence for Candida infections.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsDOA

>=2 yrsAge

multipleIndications

Coverage Criteria for Vfend (voriconazole)

Aspergillosis, Febrile Neutropenia, Mycosis, Serious Fungal Infection

Authorization may be granted for the requested drug when ALL of the following criteria are met:

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Indication: The requested drug is being prescribed for ANY of the following: treatment of invasive aspergillosis (including invasive pulmonary aspergillosis); serious fungal infection caused by Scedosporium apiospermum and Fusarium species; prophylaxis of invasive aspergillosis in a high-risk patient; chronic pulmonary aspergillosis; empiric antifungal therapy for febrile neutropenia in a high-risk patient; mycosis due to Scedosporium prolificans.

Route: The patient will use the requested drug orally or intravenously.

Oral suspension justification: If the request is for voriconazole powder for oral suspension, the patient meets ONE of the following: has difficulty swallowing solid oral dosage forms (e.g., tablets); requires a dose that cannot be obtained using the commercially available tablets.

Candida Infection

Authorization may be granted for Candida infections when ALL of the following criteria are met:

Indication: The requested drug is being prescribed for ANY of the following: candidemia in a non-neutropenic patient; disseminated Candida infection in the skin; Candida infection in the abdomen, kidney, bladder wall, or wounds; esophageal candidiasis; or oropharyngeal candidiasis.

Prior therapy requirement: The patient meets ONE of the following: experienced an inadequate treatment response to an alternative antifungal therapy; experienced an intolerance to an alternative antifungal therapy; has a contraindication that would prohibit a trial of an alternative antifungal therapy.

This represents a step-therapy/alternatives requirement for Candida indications.

Route: The patient will use the requested drug orally or intravenously.

This policy defines the specific indications for which prior authorization may be granted for voriconazole (Vfend). Requests for uses outside the indications listed in this policy do not have authorization language provided and therefore are not supported by the policy criteria. The listed indications include treatment of invasive aspergillosis (including invasive pulmonary aspergillosis), serious Scedosporium and Fusarium infections, prophylaxis of invasive aspergillosis in high‑risk patients, chronic pulmonary aspergillosis, empiric antifungal therapy for febrile neutropenia in high‑risk patients, mycosis due to Scedosporium prolificans, and several Candida‑related infections. When a request is for an indication not enumerated here, it will not meet the specific authorization standards outlined in this document.

For indications not explicitly listed or where additional clinical justification is required, the policy requires documentation that aligns with the applicable indication criteria. For Candida indications, the request must document that the patient meets ONE of the following: an inadequate treatment response to an alternative antifungal, an intolerance to an alternative antifungal, or a contraindication to trial of an alternative antifungal. More generally, the prescriber must indicate the specific listed indication being treated and confirm the intended route of administration (oral or intravenous). If voriconazole powder for oral suspension is requested, documentation must show that the patient either has difficulty swallowing solid oral dosage forms or requires a dose not achievable with commercially available tablets. Absent this required documentation or indication‑specific evidence, the request may be considered not medically necessary.

Provider Actions, Requirements, and Decision Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for voriconazole (Vfend). Approval duration: up to 6 months. Approval is contingent on meeting the clinical criteria for the requested indication (e.g., invasive aspergillosis, serious Scedosporium/Fusarium infection, prophylaxis in high‑risk patients, empiric therapy in febrile neutropenia, or qualifying Candida infections) and appropriate route of administration (oral or IV).

Duration of approval: 6 months (Policy 241-A)
Oral or IV administration required; powder for oral suspension allowed only if patient has difficulty swallowing tablets or requires a noncommercial tablet dose

Step Therapy

Step Therapy / Alternative Therapy Requirement

Step therapy: for Candida infections, a trial of an alternative antifungal is required unless the patient has documented intolerance, contraindication, or inadequate response to alternative therapy.

Applies to indications: candidemia (non‑neutropenic), disseminated skin Candida, intra‑abdominal/kidney/bladder/wound Candida, esophageal or oropharyngeal candidiasis
Acceptable alternatives should be documented in the request (agent, dates, and reason for failure/intolerance)

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the prior authorization request to support medical necessity.

Specify the treated indication (e.g., invasive aspergillosis, Candida infection subtype, Scedosporium/Fusarium infection, prophylaxis)
Document route of administration (oral or IV) and formulation requested (tablet, IV, or powder for oral suspension)
For Candida requests: evidence of prior trial(s) of alternative antifungal(s) or documentation of intolerance/contraindication or inadequate response
Microbiologic and laboratory documentation: obtain and provide results of fungal cultures, species identification, and other relevant laboratory studies (e.g., histopathology) when available; note that therapy may be started prior to results, but cultures should be provided when available
Clinical course and prior antifungal therapies: dates, doses, and reason for discontinuation or failure
For voriconazole oral suspension requests: documentation that patient cannot swallow tablets or requires a dose not available in tablet form

Denial Risk

Denial Triggers

Requests may be denied if required information is missing or if criteria are not met.

Missing or incomplete documentation of the treated indication or route of administration
No documentation of prior trial or intolerance to alternative antifungal therapy for Candida when step‑therapy requirement applies
Absent or pending microbiologic/laboratory data when available (e.g., cultures, species identification, histopathology) without explanation
Request for powder for oral suspension without justification (no documented difficulty swallowing tablets or need for noncommercial tablet dose)
Request for an indication not listed in the policy or lacking supporting clinical rationale

Background on Vfend (voriconazole)

Voriconazole (Vfend) is indicated for multiple serious fungal infections included in this policy's authorization criteria: treatment of invasive aspergillosis (including invasive pulmonary aspergillosis); serious infections due to Scedosporium apiospermum and Fusarium species; prophylaxis of invasive aspergillosis in high‑risk patients; chronic pulmonary aspergillosis; empiric antifungal therapy for febrile neutropenia in high‑risk patients; mycosis due to Scedosporium prolificans; and a range of Candida infections (including candidemia in non‑neutropenic patients, disseminated skin infection, intra‑abdominal and genitourinary infections, esophageal, and oropharyngeal candidiasis). The policy requires that the drug be used orally or intravenously and specifies circumstances when the oral suspension formulation is appropriate (difficulty swallowing tablets or need for a dose not available in tablet form).

Definitions

Invasive Aspergillosis — definition/entry

DefinitionInvasive aspergillosis (IA): a serious fungal infection caused by Aspergillus species; voriconazole (Vfend) is indicated for treatment in adults and pediatric patients 2 years of age and older.

Typical pathogenMajority of clinical isolates recovered in trials were Aspergillus fumigatus; other Aspergillus species have been reported.

Age indication>= 2 years (adults and pediatric patients 2 years and older).

Clinical noteCulture and species identification are recommended to guide therapy; adjust antifungal therapy when organism identification is available.

Scedosporiosis / Fusariosis — definition/entry

DefinitionScedosporiosis and Fusariosis: serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium species, including Fusarium solani.

Indication for VfendVoriconazole is indicated for treatment in adults and pediatric patients 2 years of age and older who are intolerant of, or refractory to, other therapy.

Microbiology guidanceObtain fungal culture and relevant laboratory studies (including histopathology) prior to therapy to isolate and identify causative organisms.

Therapy timingTherapy may be started empirically before culture results are known, but antifungal therapy should be adjusted once results are available.