Subject: Pretomanid PA Policy 3195-A 01-2023

Drug

pretomanid

Policy:

FDA-APPROVED INDICATIONS

Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline 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. Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients.

Limitations of Use:
•   Pretomanid Tablets are not indicated in patients with:
      º   Drug-sensitive (DS) TB
      º   Latent infection due to Mycobacterium tuberculosis.
      º   Extra-pulmonary infection due to Mycobacterium tuberculosis.
      º   TB resistant to isoniazid and rifampin who are responsive to
           standard therapy and not treatment intolerant.
      º   TB with known resistance to any component of the combination.
•   Safety and effectiveness of Pretomanid Tablets have not been
     established for its use in combination with drugs other than
     bedaquiline and linezolid as part of the recommended dosing
     regimen

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
     •   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 will be prescribed as part of a combination
          regimen with both Sirturo (bedaquiline) and Zyvox (linezolid)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Pretomanid [package insert]. Hyderabad, India: Mylan Laboratories Limited; December 2022.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, Ohio: UpToDate, Inc.; 2022; Accessed November 29, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/. Accessed November 29, 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.

June 15, 2023