CurrentCignaPolicy IP0384

Infectious Disease - Pretomanid

Defines Cigna's prior authorization and coverage criteria for pretomanid tablets (Mylan) when used as part of a combination regimen for pulmonary extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant tuberculosis in adults, including required prescriber specialty and duration of approval.

Policy Summary

PayerCigna

PolicyInfectious Disease - Pretomanid

Policy CodePolicy IP0384

Change TypeClarified (annual revisions)

Effective DateMar 1, 2026

Next Review Date

Key ActionPrior Authorization is required for Pretomanid; approvals are provided for the noted duration (6 months) and the drug must be prescribed by or in consultation with an infectious diseases specialist or pulmonologist.

SourceLink

POLICY UPDATE CHANGES

Annual Revision (3/15/2025) updated approval duration from 9 months to 6 months and made other non-clinical wording updates; 3/1/2026 annual revision indicates no criteria changes.

1Covered Indication (FDA-approved)

4Required criteria items

6 monthsStandard approval duration

Coverage Summary

Defines Cigna's prior authorization and coverage criteria for pretomanid tablets (Mylan) when used as part of a combination regimen for pulmonary extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant tuberculosis in adults, requires that pretomanid be prescribed in combination with bedaquiline (Sirturo) and linezolid, must be prescribed by or in consultation with an infectious diseases specialist or pulmonologist, and approvals are provided for 6 months.

Initial Therapy Criteria (FDA-Approved Indication)

FDA-Approved Indication (Approve for 6 months)

Approve for 6 months if the patient meets ALL of the following (A, B, C, and D):

Conditions Not Covered

Pretomanid for any other use is considered not medically necessary.

Any use not explicitly meeting the FDA-Approved Indication criteria above (including drug-sensitive TB, latent TB infection, extra-pulmonary TB, or multidrug-resistant TB that is not treatment-intolerant or nonresponsive to standard therapy)

Provider Actions & Billing

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of Pretomanid; approvals provided for the duration noted (6 months = 6 months).

Approval duration: 6 months

Documentation Required

Specialist prescribing requirement

Pretomanid must be prescribed by or in consultation with an infectious diseases specialist or pulmonologist; due to specialized evaluation and monitoring requirements, documentation of specialist involvement may be required for approval.

Infectious disease specialist or pulmonologist involvement may be required for approval.

Billing Rule

Use appropriate diagnosis codes

Reimbursement is provided only if the requested service is submitted with covered diagnosis/procedure code(s) that align with this Coverage Policy; claims without covered codes will be denied as not covered.

Claims submitted without covered codes will be denied as not covered.

Clinical Evidence & References

Prescribing information: Mylan Pretomanid tablets prescribing information, November 2024.

Guideline: WHO consolidated guidelines on drug-resistant TB, Module 4 (2025).

Note: approval was based on limited clinical safety and efficacy data.

Background

Pretomanid is a nitroimidazole indicated as part of a combination regimen with Sirturo (bedaquiline) and linezolid for the treatment of pulmonary extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant tuberculosis in adults. It is not indicated for drug-sensitive TB, latent TB infection, extra-pulmonary TB, or multidrug-resistant TB that is responsive to standard therapy. The prescribing information notes a typical total regimen duration of 26 weeks, and dosing of the combination regimen may be extended beyond 26 weeks per the prescribing information.

Treatment-intolerant tuberculosis: TB for which the patient cannot tolerate standard therapy (as referenced in policy; specific clinical definition per prescriber documentation).

Nonresponsive multidrug-resistant tuberculosis: Multidrug-resistant TB that has not responded to standard therapy (as referenced in policy; requires documentation).

Revision History

2025-03-15Annual Revision

updated approval duration from 9 months to 6 months and non-clinical wording updates

2026-03-01Annual RevisionLatest

no criteria changes