Subject: Sivextro PA Policy 1161-A UDR 03-2024
Policy:
FDA-APPROVED INDICATIONS
Acute Bacterial Skin and Skin Structure Infections
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
Authorization may be granted for the requested drug when the following criteria is met:
• The patient is being converted from IV (intravenous) Sivextro (tedizolid) as prescribed by or in
consultation with an Infectious Disease specialist
Acute Bacterial Skin or Skin Structure Infection (ABSSI)
Authorization may be granted when the requested drug is being prescribed for the treatment of acute bacterial skin or skin structure infection (ABSSI) when ALL of the following criteria are met:
• The requested drug is being prescribed for a patient 12 years of age or older
• The infection is caused by susceptible isolates of ANY 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),
° Enterococcus faecalis
• The infection is proven or strongly suspected to be caused by susceptible bacteria based on
culture and susceptibility OR local epidemiology and susceptibility patterns
• The patient meets ONE of the following:
° The patient has experienced an inadequate treatment response, intolerance, or
contraindication to alternative therapies
° The bacteria are NOT susceptible to any other antibiotics
DURATION OF APPROVAL (DOA)
• 1161-A: DOA: 6 days
Place of Service:
Outpatient
The above policy is based on the following references:
- Sivextro [package insert]. Rahway, NJ: Merck Sharp & Dohme LLC; March 2023.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed February 5, 2024.
- Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 02/05/2024).
- 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. Clinical Infectious Diseases 2014;59(2):e10-52.
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 11, 2024
