Subject: Vfend PA Policy 241-A 01-2023

Drug

VFEND  (voriconazole)

Policy:

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) in adults and pediatric patients 2 years of age and older.
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.

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.

Compendial Uses
Febrile Neutropenia, Empiric Antifungal Therapy, High-Risk Patients^2,3,6,8
Invasive Aspergillosis, Prophylaxis, High-Risk Patients^3,6
Mycosis, Due to Scedosporium prolificans³
Oropharyngeal Candidiasis^2,3,5
Pulmonary Aspergillosis, Chronic^3,6


COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
     •   The requested drug is being prescribed for any of the following:
          A) treatment of invasive aspergillosis (including invasive
          pulmonary aspergillosis), B) serious fungal infection caused by
          Scedosporium apiospermum and Fusarium species, C)
          prophylaxis of invasive aspergillosis in a high-risk patient, D)
          chronic pulmonary aspergillosis, E) empiric antifungal therapy
          for febrile neutropenia in a high-risk patient, F) mycosis due to
          Scedosporium prolificans
     OR
          The requested drug is being prescribed for any of the following:
          A)  candidemia in a non-neutropenic patient, B) disseminated
          Candida infection in the skin, C) Candida infection in the
          abdomen, kidney, bladder wall, or wounds, D) esophageal
          candidiasis, E) oropharyngeal candidiasis
          AND
          º   The patient has experienced an inadequate treatment
               response to an alternative antifungal therapy
          OR
          º   The patient has experienced an intolerance to an alternative
               antifungal therapy
          OR
          º   The patient has a contraindication that would prohibit a trial
               of an alternative antifungal therapy
     AND
     •   The patient will use the requested drug orally or intravenously
     AND
     •   If the request is for voriconazole powder for oral suspension, the
          patient meets one of the following: A) has difficulty swallowing
          solid oral dosage forms (e.g., tablets), B) requires a dose that
          cannot be obtained using the commercially available tablets

Place of Service:

Outpatient

The above policy is based on the following references:

1. Vfend [package insert]. New York, New York: Pfizer Inc.; October 2022.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed December 9, 2022.
3. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed December 9, 2022.
4. Centers for Disease Control and Prevention. Fungal Diseases. Available at: https://www.cdc.gov/fungal/diseases/aspergillosis/definition.html. Accessed December 9, 2022.
5. 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.
6. 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.
7. 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.
8. 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.

June 15, 2023