Clinical Policy: Pretomanid
Customize your policy alerts
Sign up for Ambetter Georgia Policy CP.PMN.222 alerts
Get alerted when Policy CP.PMN.222 changes without checking for updates manually.
Monitor payer policy activity
Policy governing medical necessity and prior authorization criteria for pretomanid when used as part of a combination regimen (bedaquiline and linezolid) to treat specified drug-resistant pulmonary tuberculosis in Ambetter Georgia members.
Lowered minimum age for therapy from 15 to 14 years.
Updated recommended linezolid dosing from 1,200 mg to 600 mg per CDC recommendations.
Clarified approval duration as 26 weeks with possible extension to 9 months for delayed culture conversion.
Coverage Criteria for Pretomanid (BPaL)
Initial Therapy
Covered when ALL of the following are met:
Prior authorization may be required for Sirturo (bedaquiline) and linezolid; provider must submit documentation (office chart notes, laboratory results including genotypic or phenotypic resistance testing, or other clinical information) supporting that member meets all approval criteria.
Continuation Therapy
Continued therapy covered when ALL of the following are met:
Approval duration up to a total treatment duration of 26 weeks (extendable to 9 months/39 weeks if evidence of delayed culture conversion).
Not Medically Necessary / Not Authorized
Not authorized:
Refer to off‑label or formulary policies for other uses.
Pretomanid is indicated only as part of the BPaL regimen (bedaquiline, pretomanid, linezolid) for specific drug‑resistant pulmonary tuberculosis cases. It is not indicated for drug‑sensitive TB, latent Mycobacterium tuberculosis infection, or extra‑pulmonary TB. The agent is also not indicated when TB is responsive to standard therapy (for example, isoniazid and rifampin‑resistant disease that responds to standard regimens) or when the organism has known resistance to any component of the BPaL combination. Safety and effectiveness have not been established for use of pretomanid with drugs other than bedaquiline and linezolid, therefore use outside that combination is not supported.
For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy. Refer to the applicable state Medicaid manual for specific coverage rules and any provisions that supersede this policy.
Use of pretomanid outside the specified combination regimen with bedaquiline and linezolid, or for non‑pulmonary or drug‑sensitive TB, is considered not medically necessary under this policy. Non‑FDA‑approved indications not addressed by this policy require sufficient supporting documentation per applicable off‑label use policies and evidence‑of‑coverage provisions before consideration.
Drug Dosing, Duration, and Coding Notes
Provider Requirements, Authorization, and Documentation
Prior authorization required — show diagnosis, resistance, and expert involvement
Prior authorization is required. Requests must demonstrate: diagnosis of pulmonary tuberculosis with the specified resistance pattern, prescribed by or in consultation with a tuberculosis expert, prescribed in combination with bedaquiline (Sirturo) and linezolid, and a dose that does not exceed 200 mg (1 tablet) per day.
- Diagnosis of pulmonary TB
- Documentation of resistance (see initial criteria: resistance to isoniazid and rifampin with intolerance/nonresponse, or resistance including fluoroquinolones and a second-line injectable)
- Prescribed by or in consultation with a TB expert (e.g., public health department or TB Centers of Excellence)
- Prescribed in combination with Sirturo (bedaquiline) and linezolid
- Dose ≤ 200 mg (1 tablet) per day
Policy guides prior authorization and coverage decisions
This clinical policy is intended to guide medical necessity determinations and assist in administering benefits; prior authorization requirements and final coverage decisions follow the Health Plan's administrative procedures and coverage documents.
- Policy provides medical necessity guidance used to assist coverage decisions and benefit administration
- Prior authorization requirements are governed by the Health Plan's administrative procedures and coverage documents
Review therapeutic alternatives (see Appendix B)
Consider listed therapeutic alternatives before initiating pretomanid where clinically appropriate; alternatives include first- and second-line agents such as pyrazinamide, cycloserine, ethionamide, and amikacin (see Appendix B for dosing guidance).
- Pyrazinamide
- Cycloserine
- Ethionamide
- Amikacin/kanamycin
- Moxifloxacin or levofloxacin as appropriate per regimen guidance
Follow regimen-specific and public‑health guidance when prescribing
Providers should follow CDC and regimen-specific guidance: pretomanid must be used only as part of the BPaL regimen with bedaquiline and linezolid, administered in a DOT setting per dosing guidance and safety monitoring.
- Pretomanid only used in combination with Sirturo (bedaquiline) and linezolid
- Administer in a directly observed therapy (DOT) setting where indicated
- Follow regimen dosing and safety guidance in Appendix D
Required documentation: office notes, labs, and resistance testing
Submit supporting clinical documentation with the prior authorization request, including office/chart notes and laboratory results; provide genotypic or phenotypic resistance testing that confirms multi‑drug or extensively drug‑resistant TB as applicable.
- Office chart notes and clinical rationale
- Laboratory results including genotypic or phenotypic resistance testing showing resistance to isoniazid and rifampin (and fluoroquinolones/second-line injectables when applicable)
- Documentation that pretomanid is prescribed in combination with bedaquiline and linezolid
Continuation documentation required to extend beyond 26 weeks
For requests to continue therapy beyond the standard 26 weeks, include a provider attestation of delayed treatment response within the first 8 weeks and supporting culture conversion and clinical data to justify extension (approval may extend up to 9 months for delayed conversion).
- Provider attestation describing delayed treatment response assessed within the first 8 weeks
- Supporting data: time to culture conversion, persistent culture positivity, clinical response, or adverse events
- Note: approval up to a total of 26 weeks, extendable to 9 months (39 weeks) if delayed culture conversion)
Follow Health Plan administrative policies and document compliance
Providers must follow the Health Plan's administrative policies and procedures and document accordance with applicable coverage documents (evidence of coverage, certificate of coverage, policy or contract) when submitting requests and maintaining treatment records.
- Adhere to Health Plan-level administrative policies and procedures
- Document compliance with evidence of coverage or contract terms
Insufficient documentation may lead to denial
Requests missing required supporting documentation that the member meets all approval criteria (diagnosis, resistance testing, specialist involvement, combination therapy) may be denied.
- Missing office notes, lab results, or resistance testing increases risk of denial
- Lack of documentation of TB expert involvement or combination therapy may lead to non‑authorization
Contraindications and non‑covered indications — do not use outside specified indications
Use is not covered for patients with contraindications to bedaquiline (Sirturo) and/or linezolid or for indications not supported by the policy (e.g., drug‑sensitive TB, latent TB, extra‑pulmonary TB, or TB responsive to standard therapy).
- Contraindicated when patient has contraindications to Sirturo or linezolid
- Not authorized for drug‑sensitive, latent, extra‑pulmonary TB, or TB responsive to standard therapy
Coverage decisions subject to plan terms, exclusions, and legal requirements
Coverage decisions and administration of benefits are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state/federal requirements; plan-level rules govern final payment decisions.
- Coverage subject to evidence of coverage, certificate of coverage, policy or contract terms
- State Medicaid provisions take precedence where applicable
Background on Pretomanid and the BPaL Regimen
Pretomanid is an antimycobacterial agent whose FDA‑approved indication is limited to use as part of the BPaL regimen for a restricted population with drug‑resistant pulmonary tuberculosis. The clinical benefit and safety of pretomanid have been established only when administered in combination with bedaquiline and linezolid, and not as monotherapy or with other companion drugs.
Definitions and Abbreviations
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.