Subject: Pretomanid PA Policy 3195-A 01-2022
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 extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). 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 the following conditions:
o Drug-sensitive (DS) tuberculosis
o Latent infection due to Mycobacterium tuberculosis.
o Extra-pulmonary infection due to Mycobacterium tuberculosis.
o MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy.
• 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 extensively-drug resistant (XDR) or
treatment-intolerant/nonresponsive multidrug-resistant (MDR) tuberculosis
AND
• The requested drug will be prescribed as part of a combination regimen with Sirturo (bedaquiline)
and Zyvox (linezolid)
Place of Service:
Outpatient
The above policy is based on the following references:
- Pretomanid [package insert]. Hyderabad, India: Mylan Laboratories Limited for The Global Alliance for TB Drug Development (TB Alliance); April 2020.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, Ohio: UpToDate, Inc.; 2021; Accessed December 2021.
- Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/. Accessed December 2021.
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 12, 2022
