Subject: Sirturo PA Policy 923-A 03-2023

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:
ºLatent infection due to Mycobacterium tuberculosis
ºDrug-sensitive tuberculosis
ºExtra-pulmonary tuberculosis
ºInfections 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

Compendial 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.^2,4-6

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
          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
     •   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 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