CurrentCignaPolicy IP0494

Sirturo (bedaquiline) — Prior Authorization and Coverage Criteria for Pulmonary Tuberculosis

This policy governs prior authorization and coverage criteria for Sirturo (bedaquiline fumarate tablets) when used to treat pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to rifampin and isoniazid across Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySirturo (bedaquiline) — Prior Authorization and Coverage Criteria for Pulmonary Tuberculosis

Policy CodePolicy IP0494

Change TypeMaterial revisions to age/weight limits, treatment duration, indication wording, and prescriber requirement

Effective Date

Next Review Date

Key ActionObtain Prior Authorization; approvals are provided for 6 months when all FDA‑approved indication criteria are met and Sirturo is prescribed by or in consultation with an infectious diseases specialist or pulmonologist.

SourceLink

POLICY UPDATE CHANGES

Age requirement changed from ≥ 5 years to ≥ 2 years and weight requirement changed from ≥ 15 kg to ≥ 8 kg.

Approved treatment duration for tuberculosis changed from 9 months to 6 months.

Updated indication language to specify Mycobacterium tuberculosis resistant to at least rifampin and isoniazid and removed reference to accelerated approval.

Specialist prescriber requirement updated to include pulmonologist in addition to infectious diseases specialists.

6 monthsapproved treatment duration for TB

≥ 2 yrsminimum age for coverage

≥ 8 kgminimum weight for coverage

Prior Authorizationauthorization requirement

Not covereduses considered not medically necessary

Coverage Criteria for Sirturo (bedaquiline)

Initial therapy (FDA‑approved indication)

Approve for 6 months if the patient meets ALL of the following (A–E):

FDA-Approved Indication for Tuberculosis: A) Patient is ≥ 2 years of age; AND B) Patient weighs ≥ 8 kg; AND C) Patient has Mycobacterium tuberculosis resistant to rifampin and isoniazid; AND D) Sirturo is prescribed as part of a combination regimen with other anti-tuberculosis agents; AND E) The medication is prescribed by or in consultation with an infectious diseases specialist or pulmonologist.6 months approval

Approvals provided for duration noted; 1 month = 30 days.

Sirturo (bedaquiline) is not indicated for the following uses and these are explicitly excluded from coverage: treatment of latent Mycobacterium tuberculosis infections, treatment of drug-sensitive tuberculosis, management of extra-pulmonary tuberculosis, and treatment of infections caused by non-tuberculous mycobacteria.

Use of Sirturo for any purpose other than the specified FDA‑approved pulmonary tuberculosis indication described in this policy is considered not medically necessary and may be denied.

Policy Summary

PayerCigna

PolicySirturo (bedaquiline) — Prior Authorization and Coverage Criteria for Pulmonary Tuberculosis

Policy CodePolicy IP0494

Change TypeMaterial revisions to age/weight limits, treatment duration, indication wording, and prescriber requirement

Effective Date

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Sirturo. Approvals are provided for 6 months when all FDA‑approved indication criteria are met. In cases where approval duration is expressed in months, 1 month = 30 days. Sirturo must be prescribed by or in consultation with a physician who specializes in the condition being treated (infectious disease specialist or pulmonologist).

Prior Authorization required.
Approvals provided for 6 months when FDA‑approved indication criteria are met.
1 month = 30 days for duration counting.
Prescribed by or in consultation with an infectious diseases specialist or pulmonologist.

Billing Rule

Coding / Claim Submission

Claims submitted without covered diagnosis or procedure codes will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of submission.

Claims lacking covered diagnosis or procedure codes → deny as not covered.
Use most appropriate codes as of the submission date.

Denial Risk

Indication Not Covered

Use of Sirturo for any indication other than the FDA‑approved tuberculosis indication is considered not medically necessary and may be denied. Criteria will be updated as new published data become available.

Sirturo for non‑FDA‑approved uses = Not medically necessary / may be denied.
Policy will be revised if new evidence emerges.

Documentation Required

PA and Prescriber Documentation

For prior authorization requests, include documentation that demonstrates the patient meets all FDA‑approved indication criteria (age ≥ 2 years, weight ≥ 8 kg, Mycobacterium tuberculosis resistant to rifampin and isoniazid, Sirturo prescribed as part of a combination anti‑tuberculosis regimen) and that the prescribing clinician is or consulted with an infectious disease specialist or pulmonologist.

Document age and weight.
Document resistant M. tuberculosis to rifampin and isoniazid.
Document combination regimen with other anti‑tuberculosis agents.
Document specialist prescriber or consult (infectious disease or pulmonology).

OpenPayer

Sirturo (bedaquiline) — Prior Authorization and Coverage Criteria for Pulmonary Tuberculosis

Coverage Criteria for Sirturo (bedaquiline)

Provider Actions, Prior Authorization, and Documentation

Background

Definitions and Limitations of Use