CurrentCignaPolicy N/A

Infectious Disease - Sirturo (bedaquiline) Prior Authorization Policy

This policy governs prior authorization requirements and medical necessity criteria for coverage of Sirturo (bedaquiline fumarate tablets) for treatment of pulmonary tuberculosis within Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInfectious Disease - Sirturo (bedaquiline) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJul 16, 2025

Key ActionObtain prior authorization and provide documentation showing age/weight, drug resistance evidence, combination regimen, and infectious diseases specialist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproved duration for FDA indication

≥5 yrs / ≥15 kgminimum patient age/weight

Not coveredstance for non-indicated uses

ID specialistprescriber requirement

Coverage and Medical Necessity Criteria

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Initial Therapy (FDA-approved)

Covered when ALL of the following are met for the FDA-approved indication (approve for 6 months):

FDA-Approved Indication Criteria: A) Patient is ≥ 5 years of age; AND B) Patient weighs ≥ 15 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 antituberculosis agents; AND E) The medication is prescribed by or in consultation with an infectious diseases specialist.

Approval duration: 6 months.

Sirturo (bedaquiline) is limited to treatment of pulmonary tuberculosis caused by Mycobacterium tuberculosis that is resistant to at least rifampin and isoniazid. It should not be used for latent tuberculosis infection, drug‑sensitive TB, extra‑pulmonary TB, or infections caused by non‑tuberculous mycobacteria. Use of Sirturo is reserved for situations when an effective alternative regimen cannot otherwise be provided, and treatment should be part of a combination antituberculosis regimen.

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are provided for the duration noted in the policy (6 months for the FDA-approved indication). Sirturo must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., infectious diseases specialist).

Approval duration: 6 months for FDA-approved pulmonary TB indication (1 month = 30 days)
Prescriber requirement: specialist or consultant (infectious diseases)

Note

Reserve Use / Guideline Context

Reserve Sirturo for use when an effective treatment regimen cannot otherwise be provided. Use should follow drug-susceptibility testing and current guideline recommendations for drug-resistant tuberculosis regimen design.

Indication context: treatment of pulmonary TB due to M. tuberculosis resistant to at least rifampin and isoniazid
Guideline context: follow WHO and ATS/CDC/ERS/IDSA guidance; perform drug susceptibility testing to guide regimen selection

Documentation Required

Required Clinical Documentation

Document the following in the medical record when requesting authorization: patient age and weight, microbiologic evidence of resistance to rifampin and isoniazid (e.g., culture, molecular testing), that Sirturo is being prescribed as part of a combination antituberculosis regimen, and rationale that an effective regimen cannot otherwise be provided. Also document the consulting or prescribing specialist.

Required documentation: age (≥ 5 years) and weight (≥ 15 kg)
Evidence of resistance: laboratory documentation of Mycobacterium tuberculosis resistant to rifampin and isoniazid
Treatment plan: combination regimen details and clinical rationale for Sirturo use
Prescriber: name/role of infectious diseases or TB specialist involved

Denial Risk

Not Covered Uses

Use of Sirturo for any indication other than the specified FDA‑approved indication (pulmonary tuberculosis due to M. tuberculosis resistant to at least rifampin and isoniazid in patients ≥ 5 years and ≥ 15 kg, given as part of a combination regimen) is considered not medically necessary.

Not covered: latent TB, drug‑sensitive TB, extra‑pulmonary TB, infections due to non‑tuberculous mycobacteria, and any other non‑FDA‑approved uses

Background

Sirturo (bedaquiline fumarate) is a diarylquinoline antimycobacterial indicated as part of combination therapy for pulmonary tuberculosis caused by Mycobacterium tuberculosis resistant to at least rifampin and isoniazid in patients aged ≥ 5 years and weighing ≥ 15 kg. The prescribing information specifies a total treatment duration of 24 weeks (6 months). Use is intended within guideline‑based regimens and when an effective alternative treatment cannot be provided.

Definitions

inv-09: Sirturo (bedaquiline fumarate) — key facts

Generic nameBedaquiline fumarate

Brand nameSirturo

Drug classDiarylquinoline antimycobacterial

FDA-approved indicationAs part of combination therapy for pulmonary tuberculosis caused by Mycobacterium tuberculosis resistant to at least rifampin and isoniazid in patients ≥ 5 years (≥ 15 kg)

Recommended treatment duration24 weeks (6 months)

Limitations of useNot for latent TB, drug-sensitive TB, extra-pulmonary TB, or infections caused by non-tuberculous mycobacteria

Use contextReserve for when an effective treatment regimen cannot otherwise be provided; should be used with guideline-directed drug susceptibility testing and regimen selection