Subject: Vfend PA Policy 241-A 01-2022
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 Patients2,3,6,8
Invasive Aspergillosis, Prophylaxis, High-Risk Patients3,6
Mycosis, Due to Scedosporium prolificans3
Oropharyngeal Candidiasis2,3,5
Pulmonary Aspergillosis, Chronic3,6
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
• The patient has experienced an inadequate
treatment response to an alternative antifungal
therapy
OR
• The patient has experienced an intolerance to an
alternative antifungal therapy
OR
• 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:
- Vfend [package insert]. New York, New York: Pfizer Inc.; January 2021.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed November 9, 2021.
- Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed November 9, 2021.
- Centers for Disease Control and Prevention. Fungal Diseases. Available at: https://www.cdc.gov/fungal/diseases/aspergillosis/definition.html. Accessed December 15, 2021.
- 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.
June 12, 2022
