Subject: Pretomanid PA Policy 3195-A UDR 01-2024

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:
    °   Drug-sensitive (DS) TB
    °   Latent infection due to Mycobacterium tuberculosis.
    °   Extra-pulmonary infection due to Mycobacterium tuberculosis.
    °  TB resistant to isoniazid and rifampin who are responsive to standard therapy and not treatment
        intolerant.
    °   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

Pulmonary Tuberculosis (TB)
Authorization may be granted when 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 when the following criteria is met:
  •   The requested drug will be prescribed as part of a combination regimen with Sirturo (bedaquiline)
       AND Zyvox (linezolid)

DURATION OF APPROVAL (DOA)

• 3195-A: DOA: 12 months

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. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed December 4, 2023.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 12/04/2023).

 

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.

June 16, 2024