Subject: Sivextro PA Policy 1161-A 03-2023

Drug

SIVEXTRO  (tedizolid))

Policy:

FDA-APPROVED INDICATIONS
Sivextro is an oxazolidinone-class antibacterial indicated in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), and Enterococcus faecalis.

Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sivextro and other antibacterial drugs, Sivextro should be used only to treat ABSSSI 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.


COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
     •   The patient is being converted from IV (intravenous) Sivextro
          (tedizolid) as prescribed by or in consultation with an Infectious
          Disease specialist
     OR
     •   The requested drug is being prescribed for a patient 12 years of
          age or older with an acute bacterial skin or skin structure
          infection (ABSSSI) caused by susceptible isolates of any of the
          following Gram-positive microorganisms: A) Staphylococcus 
          aureus (including methicillin-resistant [MRSA] and methicillin-
          susceptible [MSSA] isolates), B) Streptococcus pyogenes, C)
          Streptococcus agalactiae, D) Streptococcus anginosus Group
          (including Streptococcus anginosus, Streptococcus intermedius,
          and Streptococcus constellatus), E) Enterococcus faecalis
          AND
     •   The infection is proven or strongly suspected to be caused by
          susceptible bacteria based on culture and susceptibility OR local
          epidemiology and susceptibility patterns
          AND
     •   The patient has experienced an inadequate treatment response,
          intolerance, or contraindication to alternative therapies OR the
          bacteria are NOT susceptible to any other antibiotics

Place of Service:

Outpatient

The above policy is based on the following references:

1. Sivextro [package insert]. Fort Washington, PA: Nabriva Therapeutics US, Inc.; July 2022.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed January 29, 2023.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed January 29, 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.

August 13, 2023