Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Vfend PA 241-A P01-2025
Drug
VFEND(voriconazole)
Policy:
Indications
FDA-approved Indications
Invasive Aspergillosis
Vfend is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus.
Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections
Vfend is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds.
Esophageal Candidiasis
Vfend is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC).
Scedosporiosis and Fusariosis
Vfend is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy.
Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
The patient will use the requested drug orally or intravenously.
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, Talaromycosis
Authorization may be granted for the requested drug when ALL of the following criteria are met:
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.
Oropharyngeal candidiasis.
The patient meets ONE of the following criteria:
The patient has experienced an inadequate treatment response to an alternative antifungal therapy.
The patient has experienced an intolerance to an alternative antifungal therapy.
The patient has a contraindication that would prohibit a trial of an alternative antifungal therapy.
The patient will use the requested drug orally or intravenously.
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.
Duration of Approval (DOA)
241-A: DOA: 6 months
Place of Service:
Outpatient
The above policy is based on the following references:
Vfend [package insert]. New York, New York: Roerig, Division of Pfizer Inc.; August 2024.
Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed December 2, 2024.
Li, Philip Kam-Tao et al. ISPD peritonitis guideline recommendations: 2022 update on prevention and treatment. Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis vol. 42,2 (2022): 110-153
Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. National Institutes of Health, Centers for Disease Control and Prevention, HIV Medicine Association, and Infectious Diseases Society of America. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection. Accessed December 3, 2024.
Pappas PG, Kauffman CA, Andes DR, et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis 2016;62(4):e1-50.
Patterson TF, Thompson III GR, Denning DW, et al. Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis 2016;63(4):e1-60.
Stevens DL, Bisno AL, Chambers HF, et al. Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections: 2014 Update by the Infectious Diseases Society of America. Clin Infect Dis 2014;59(2):e10-52.
Freifeld AG, Bow EJ, Sepkowitz KA et al. Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update by the Infectious Diseases Society of America. Clin Infect Dis 2011:52(4):e56-93.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
