CurrentCignaPolicy N/A

Antifungals - Voriconazole (Oral) Prior Authorization Policy

Defines Cigna prior authorization requirements and approved indications/durations for oral voriconazole (Vfend and generics) for insured members; applies to providers submitting prescription benefit requests.

Policy Summary

PayerCigna

PolicyAntifungals - Voriconazole (Oral) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised, Clarified, Added

Effective DateN/A

Next Review DateJul 16, 2025

Key ActionPrior authorization is required for Vfend and generic voriconazole; approvals are granted for specified durations per indication and a step-therapy trial of generic voriconazole is required before brand Vfend.

SourceLink

POLICY UPDATE CHANGES

Policy name changed to include 'Step Therapy' and a Step Therapy requirement (trial of generic voriconazole prior to brand Vfend) was previously added and later modified.

The indication 'Fungal Infection (Systemic) in a Patient with Cancer and Neutropenia - Prophylaxis' was reworded to align with NCCN and examples of cancers were added as a note.

Fungal Infection (Systemic) in a Patient with Graft-Versus-Host Disease - Prophylaxis was added as a condition of approval.

14listed approved indications/uses

12 monthsAspergillus & blastomycosis duration

3 monthsmost systemic Candida treatment

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Coverage and Medical Necessity Criteria

Medically necessary indications

Covered when the requested oral voriconazole is for one of the FDA‑approved indications or other uses with supportive evidence listed below; approvals are for the durations specified.

Approved indications and other uses: Includes FDA-approved indications: (1) Aspergillus Infection - Treatment; (2) Candida (Systemic) Infection - Treatment; (3) Esophageal Candidiasis - Treatment; (4) Fusarium Infection - Treatment; (5) Scedosporium apiospermum Infection - Treatment. Other uses with supportive evidence include: (6) Aspergillus Infection - Prophylaxis; (7) Blastomycosis - Treatment; (8) Candida Endophthalmitis - Treatment; (9) Fungal Infection (Systemic) in a Patient with Cancer and Neutropenia - Prophylaxis; (10) Fungal Infection (Systemic) in a Patient with Graft‑versus‑Host Disease - Prophylaxis; (11) Fungal Infection (Systemic) in a Patient with Human Immunodeficiency Virus (HIV) - Prophylaxis or Treatment; (12) Oropharyngeal Candidiasis (Fluconazole‑Refractory) - Treatment; (13) Fungal Infection (Systemic) that is Susceptible to Voriconazole - Treatment; (14) Patient is Currently Receiving Voriconazole - Approve to complete course.See durations specified per indication (approval durations listed below).

Approvals are provided for the duration specified for each indication (1 month = 30 days when duration is expressed in months).

Voriconazole (Vfend and generics) is considered not medically necessary for uses other than those expressly listed in this policy. This includes any indication, duration, or clinical circumstance not enumerated under the policy’s approved indications and supportive-evidence uses. The policy will be maintained and updated as new published clinical data and guideline recommendations become available; providers should refer to the most recent policy version for current covered indications and required documentation.

Any use of voriconazole that is not explicitly listed in the approved indications within this policy is considered not medically necessary and is not eligible for coverage under the prescription benefit.

Covered Products, Codes, and Approval Durations

Covered productsNDC|HCPCS|mixedCovered

Vfend

Vfend (voriconazole tablets and oral suspension - Roerig/Pfizer) and generic voriconazole tablets and oral suspension

Approval durations — per indication

Aspergillus infection — TreatmentApprove for 12 months

Candida (systemic) infection — TreatmentApprove for 3 months

Esophageal candidiasis — TreatmentApprove for 3 months

Aspergillus infection — ProphylaxisApprove for 6 months

Blastomycosis — TreatmentApprove for 12 months

Fungal infection (systemic) in GVHD — ProphylaxisApprove for 6 months

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vfend (voriconazole tablets and oral suspension – Roerig/Pfizer) and generic voriconazole tablets and oral suspension. Approvals are granted for the durations specified in the policy; when duration is expressed in months, 1 month = 30 days.

Prior authorization required for both brand Vfend and generic voriconazole (tablet and oral suspension).
Approvals issued for the duration specified in the policy; 1 month = 30 days.

Step Therapy

Step Therapy — Generic First

When a prescriber requests brand Vfend but the patient has not met the step therapy requirement, coverage will default to authorization of the corresponding generic voriconazole product (tablet or oral suspension). A trial of the corresponding generic voriconazole is required prior to approval of brand Vfend (Step 1: generic; Step 2: brand). The policy no longer includes an exception based on formulation-inactive-ingredient differences for presumed allergy/serious adverse reaction.

Drug Definitions

Voriconazole — definition and clinical uses

Drug class and descriptionVoriconazole — an azole antifungal agent used for treatment of invasive aspergillosis, candidemia and other deep tissue Candida infections, esophageal candidiasis, and select molds (Scedosporium, Fusarium)

FDA‑approved indications (examples)Includes invasive aspergillosis (treatment), candidemia and other deep tissue Candida infections, and esophageal candidiasis

Uses supported by clinical guidelinesIDSA and NCCN recommend voriconazole for treatment and prevention of invasive aspergillosis and for candidemia/candidiasis; guidelines note use for certain Scedosporium and Fusarium infections

HIV guidanceHIV opportunistic infection guidance recommends voriconazole as an option for prophylaxis/treatment of several fungal infections in patients with HIV

Background and Clinical Context

Voriconazole is an azole antifungal agent approved and guideline-supported for serious invasive fungal infections and certain prophylaxis indications in high-risk patients. Typical clinical uses include treatment of invasive aspergillosis, systemic Candida infections (including candidemia and deep tissue candidiasis), esophageal candidiasis, and select mold infections such as Fusarium and Scedosporium species. Guidelines from infectious disease authorities support voriconazole for these and select prophylactic settings in immunocompromised populations (for example, neutropenia, graft-versus-host disease, and some HIV-related opportunistic infections). Dosing, formulation (tablets or oral suspension), and recommended durations vary by indication and patient factors; prior authorization is required for Vfend and generic voriconazole products with approvals granted for indication-specific durations.