Subject: Sirturo PA Policy 923-A 03-2022

Drug

SIRTURO  (bedaquiline)

Policy:

FDA-approved Indications
Sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve Sirturo for use when an effective treatment regimen cannot otherwise be provided.

This indication is approved under accelerated approval based on time to sputum culture conversion. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Limitations of Use:
    •   Do not use Sirturo for the treatment of:
             o   Latent infection due to Mycobacterium tuberculosis
             o   Drug-sensitive tuberculosis
             o   Extra-pulmonary tuberculosis
             o   Infections caused by non-tuberculous mycobacteria
    •   The safety and efficacy of Sirturo in the treatment of HIV infected patients with MDR-TB have not been
         established as clinical data are limited

Off Label Uses
Combination regimen with pretomanid and linezolid for the treatment of pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB)^5,6 

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
    •   The requested drug is being prescribed as part of combination therapy in a patient with pulmonary
         multi-drug resistant tuberculosis (MDR-TB)
         AND
    •   Another effective treatment regimen cannot be used instead of Sirturo (bedaquiline)
    OR
    •   The requested drug is being prescribed for pulmonary extensively drug resistant (XDR) or
         treatment-intolerant/nonresponsive multidrug-resistant (MDR) tuberculosis
         AND
    •   The requested drug is being prescribed as part of a combination regimen with Pretomanid and Zyvox (linezolid)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Sirturo [package insert]. Titusville, New Jersey: Janssen Therapeutics; September 2021.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed January 27, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed January 27, 2022.
4. Centers for Disease Control and Prevention. Provisional CDC Guidelines for the Use and Safety Monitoring of Bedaquiline Fumarate (Sirturo) for the Treatment of Multidrug-Resistant Tuberculosis. MMWR. Oct 2013; 62(9):1-12.
5. Pretomanid [package insert]. Morgantown, West Virginia: Mylan Specialty L.P.; April 2020.
6. Update of WHO guidelines on the programmatic management of drug resistant TB. Geneva: World Health Organization; 2019. https://www.who.int/tb/features_archive/Update-WHO-guidelines-programmatic-management-of-drug/en/. Accessed February 2022.
7. WHO consolidated guidelines on drug-resistant tuberculosis treatment. Geneva: World Health Organization; 2019. https://apps.who.int/iris/bitstream/handle/10665/311389/9789241550529-eng.pdf?ua=1. Accessed February 2022.
8. Rapid communication: key changes to treatment of drug-resistant tuberculosis. Geneva: World Health Organization; December 2019. https://www.who.int/tb/publications/2019/WHO_RapidCommunicationMDRTB2019.pdf?ua=1. Accessed February 2022.
9. WHO Global Tuberculosis Report 2020. Geneva: World Health Organization; 2020. https://apps.who.int/iris/bitstream/handle/10665/336069/9789240013131-eng.pdf. Accessed February 2022.

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 14, 2022