Subject: Zyvox PA Policy 495-A 01-2023
Policy:
FDA-APPROVED INDICATIONS
Nosocomial Pneumonia
Zyvox is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae.
Community-acquired Pneumonia
Zyvox is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only).
Complicated Skin and Skin Structure Infections
Zyvox is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae. Zyvox has not been studied in the treatment of decubitus ulcers.
Uncomplicated Skin and Skin Structure Infections
Zyvox is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin susceptible isolates only) or Streptococcus pyogenes.
Vancomycin-resistant Enterococcus faecium Infections
Zyvox is indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia.
Limitations of Use
Zyvox is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected.
The safety and efficacy of Zyvox formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zyvox and other antibacterial drugs, Zyvox should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Off Label Uses
Combination regimen with Pretomanid and linezolid for the treatment of adults with pulmonary tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug OR adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy. 2, 9,10
COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
• The patient is being converted from IV linezolid (Zyvox) as
prescribed or directed by an Infectious Disease specialist for a
NON-Tuberculosis(TB) bacterial infection
OR
• The patient has any of the following: A) an infection caused by
vancomycin-resistant Enterococcus faecium including cases with
concurrent bacteremia, B) a nosocomial (institution-acquired)
pneumonia caused by Staphylococcus aureus (methicillin-
susceptible and -resistant isolates) or Streptococcus
pneumoniae, C) community-acquired pneumonia caused by
Streptococcus pneumoniae, including cases with concurrent
bacteremia, or Staphylococcus aureus (methicillin-susceptible
isolates only), D) a complicated skin and skin structure infection
including diabetic foot infections, without concomitant
osteomyelitis, caused by Staphylococcus aureus (methicillin-
susceptible and -resistant isolates), Streptococcus pyogenes,
or Streptococcus agalactiae, E) an uncomplicated skin and skin
structure infection caused by Staphylococcus aureus (methicillin-
susceptible isolates only) or Streptococcus pyogenes
AND
º The infection is proven or strongly suspected to be caused by
susceptible bacteria
OR
• The requested drug is being prescribed for pulmonary
tuberculosis (TB) resistant to isoniazid, rifamycins, a
fluoroquinolone and a second line injectable antibacterial drug
OR TB resistant to isoniazid and rifampin, that is treatment-
intolerant or nonresponsive to standard therapy
AND
º The requested drug is being prescribed as part of a
combination regimen with Pretomanid and Sirturo
(bedaquiline)
AND
• The patient will use the requested drug orally or intravenously
Place of Service:
Outpatient
The above policy is based on the following references:
- Zyvox [package insert]. New York, NY: Pharmacia & Upjohn Co Division of Pfizer Inc; November 2021.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, Ohio: UpToDate, Inc.; 2022; Accessed December 5, 2022.
- Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/. Accessed December 5, 2022.
- Diagnosis and Treatment of Adults with Community-Acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. American Journal of Respiratory and Critical Care Medicine, Volume 200, Issue 7, 1 October 2019, Pages e45-e67.
- Lipsky B, Berendt A, Cornia P, et al. 2012 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections. Clinical Infectious Diseases 2012; 54(12):132-173.
- Kalil A, Metersky M, Klompas M, et al. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clinical Infectious Diseases 2016;1-51.
- Stevens D, Bisno A, Chambers H, et al. Practice Guidelines for the Diagnosis and Management of Skin and Soft-Tissue Infections: 2014 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases 2014;1-43.
- Gorwitz RJ, Jernigan DB, Powers JH, Jernigan JA, and Participants in the CDC Convened Experts’ Meeting on Management of MRSA in the Community. Strategies for clinical management of MRSA in the community: Summary of an experts’ meeting convened by the Centers for Disease Control and Prevention. 2006. Available at http://www.cdc.gov/mrsa/community/clinicians/index.html. Accessed December 2021.
- Pretomanid [package insert]. Morgantown, West Virginia: Mylan Specialty L.P.; December 2022.
- WHO Consolidated Guidelines on Tuberculosis. Module 4: Treatment - Drug-Resistant Tuberculosis Treatment. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO. Available at: https://www.who.int/publications/i/item/9789240007048. Accessed February 2023.
- WHO Consolidated Guidelines on Tuberculosis. Module 5: Management of Tuberculosis in Children and Adolescents
Geneva: World Health Organization; 2022. Licence: CC BY-NC-SA 3.0 IGO. Available at: https://www.who.int/publications/i/item/9789240007048. Accessed February 2023.
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
