CurrentCignaPolicy IP0494

Sirturo

Cigna's coverage policy for Sirturo (bedaquiline fumarate tablets) governing prior authorization and medical necessity for treatment of pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid in eligible patients.

Policy Summary

PayerCigna

PolicySirturo

Policy CodePolicy IP0494

Change TypeUpdated duration and indication language

Effective DateSep 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization; approvals are provided for the specified duration and require prescription by or consultation with an infectious diseases specialist.

SourceLink

POLICY UPDATE CHANGES

The approved duration for tuberculosis treatment with Sirturo was changed to 6 months (previously 9 months).

Updated indication language from 'multidrug-resistant tuberculosis' to 'Mycobacterium tuberculosis resistant to rifampin and isoniazid.'

Removed statement regarding accelerated approval; Sirturo has received traditional FDA approval.

≥5minimum patient age for coverage

≥15 kgminimum patient weight for coverage

6 monthsapproved treatment duration covered

Prior Authauthorization requirement

Infectious Diseaseprescriber specialty

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: Tuberculosis

A) Patient is ≥ 5 years of age;
B) Patient weighs ≥ 15 kg;
C) Patient has Mycobacterium tuberculosis resistant to rifampin and isoniazid;
D) Sirturo is prescribed as part of a combination regimen with other antituberculosis agents;

Policy Summary

PayerCigna

PolicySirturo

Policy CodePolicy IP0494

Change TypeUpdated duration and indication language

Effective DateSep 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization; approvals are provided for the specified duration and require prescription by or consultation with an infectious diseases specialist.

SourceLink

On This Page

Sirturo (bedaquiline) should not be used for the treatment of latent Mycobacterium tuberculosis infection, for drug‑sensitive tuberculosis, for extrapulmonary (extra‑pulmonary) tuberculosis, or for infections caused by nontuberculous mycobacteria. These limitations reflect the product labeling and policy guidance reserving Sirturo for pulmonary TB caused by M. tuberculosis with resistance to at least rifampin and isoniazid and when alternative effective regimens are not available.

Coding and Eligibility Key Data

No specific CPT/HCPCS/NDC codes listedmixed

No codes listed

inv-05: Age requirement — minimum patient age for coverage

Minimum agePatient must be ≥ 5 years of age for coverage

Age sourceFDA‑Approved Indication: Tuberculosis (see criteria A)

Policy noteApplies to pulmonary tuberculosis due to M. tuberculosis resistant to at least rifampin and isoniazid

inv-06: Weight requirement — minimum patient weight for coverage

Minimum weightPatient must weigh ≥ 15 kg for coverage

Weight sourceFDA‑Approved Indication: Tuberculosis (see criteria B)

Policy noteApplies to pulmonary tuberculosis due to M. tuberculosis resistant to at least rifampin and isoniazid

Provider Actions, Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of Sirturo. All approvals are time-limited and provided for the duration noted in the policy; when approval is authorized in months, 1 month = 30 days.

Prior authorization required for Sirturo
Approvals are time-limited; 1 month = 30 days

Note

Reserve for Limited Situations

Reserve Sirturo for use only when an effective tuberculosis treatment regimen cannot otherwise be provided. Sirturo is indicated as part of combination therapy for pulmonary TB due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid in patients ≥ 5 years (≥ 15 kg). Do not use for latent TB, drug‑sensitive TB, extra‑pulmonary TB, or nontuberculous mycobacterial infections.

Indicated for drug‑resistant pulmonary TB as part of combination therapy
Not for latent, drug‑sensitive, extra‑pulmonary TB, or nontuberculous mycobacteria

Prior Authorization

Prior Authorization and Prescriber Specialty

Sirturo must be prescribed by or in consultation with a physician who specializes in the condition being treated (infectious diseases specialist). Prior authorization approvals reference this prescriber specialty requirement and the approval duration.

Must be prescribed by or in consultation with an infectious diseases specialist
Authorization duration is specified in the policy and approvals are time-limited

Denial Risk

Coding and Claim Denial Risk

Claims submitted without covered diagnosis or procedure codes that support coverage will be denied as not covered. Use the most appropriate diagnosis and procedure codes effective on the date of service when billing.

Claims missing covered diagnosis/procedure codes will be denied as not covered
Use most appropriate codes as of date of service

Background

Sirturo (bedaquiline) is a diarylquinoline antimycobacterial indicated as part of combination therapy for pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. The product is approved for patients aged ≥ 5 years who weigh ≥ 15 kg, and the prescribing information specifies a total treatment duration of 24 weeks (6 months). Use of Sirturo is reserved for situations in which an effective alternative regimen cannot be provided, and drug susceptibility testing is recommended to guide regimen selection.

Definitions and Guideline Context

inv-12: Limitations of use — explicit limitations

Not for latent TBSirturo should not be used for the treatment of latent infections due to Mycobacterium tuberculosis

Not for drug‑sensitive TBNot indicated for drug‑sensitive tuberculosis

Not for extrapulmonary TBNot for the treatment of extra‑pulmonary tuberculosis

Not for nontuberculous mycobacteriaNot for infections caused by nontuberculous mycobacteria

inv-13: Guideline context — WHO and international guideline references

WHO recommendationWHO (2023) recommends drug susceptibility testing to assist prescribers in choosing an appropriate initial regimen

International guideline regimensGuidelines describe regimens that may include bedaquiline alongside other antituberculosis agents (e.g., rifampicin, ethambutol, levofloxacin/moxifloxacin, pretomanid, linezolid, clofazimine)

ATS/CDC/ERS/IDSA guidanceOfficial practice guideline (Dec 31, 2024) recommends a 6‑month treatment duration for certain TB regimens