CurrentNeighborhood Health Plan of Rhode IslandPolicy Sirturo PA Policy 923-A 03-2022

Sirturo (bedaquiline) prior authorization

This document defines prior authorization and coverage criteria for Sirturo (bedaquiline) for treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) and related uses; it affects prescribers and pharmacists seeking coverage through Neighborhood Health Plan (administered via CVS Caremark).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySirturo (bedaquiline) prior authorization

Policy CodePolicy Sirturo PA Policy 923-A 03-2022

Change TypeRevision — no material clinical changes

Effective DateMar 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document that Sirturo will be used as part of combination therapy for pulmonary MDR-TB and that no effective alternative regimen can be used.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA accelerated approvalapproval pathway noted

≥5 yrs, ≥15 kgmin age/weight

MDR-TB, XDR-TBindications referenced

Combination therapy requiredcoverage condition

Coverage and Clinical Criteria for Sirturo (bedaquiline)

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Authorization / Coverage criteria

Covered when ALL of the following are met:

Primary coverage requirements: Patient is being prescribed Sirturo (bedaquiline) as part of combination therapy for pulmonary multi-drug resistant tuberculosis (MDR-TB)

Supports FDA-approved indication; continued approval contingent on confirmatory trials

Reserve for situations without other effective regimens: Another effective treatment regimen cannot be used instead of Sirturo (bedaquiline)

Policy and FDA label state Sirturo should be reserved when an effective regimen cannot otherwise be provided

Extensive or treatment-intolerant disease: Requested drug is being prescribed for pulmonary extensively drug-resistant (XDR) TB or treatment-intolerant/nonresponsive MDR-TB

Off-label use described when combined with pretomanid and linezolid

Combination regimen for XDR/treatment-intolerant cases: When for XDR or treatment-intolerant/nonresponsive MDR-TB, Sirturo is prescribed as part of a combination regimen with pretomanid and linezolid

Specific regimen requirement for off-label XDR/treatment-intolerant indications

Do not use Sirturo (bedaquiline) for the treatment of drug-sensitive tuberculosis, latent Mycobacterium tuberculosis infection, extra-pulmonary tuberculosis, infections caused by non-tuberculous mycobacteria, or in situations where safety and efficacy have not been established (for example, HIV-infected patients with MDR-TB).

Use of Sirturo for drug-sensitive TB, latent TB infection, extrapulmonary TB, or non-tuberculous mycobacterial infections is not an indicated use and therefore is not covered by this policy.

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Sirturo (bedaquiline) will be covered when prescribed as part of combination therapy for pulmonary multidrug‑resistant tuberculosis (MDR‑TB) and meets the required documentation below.

Applies to adults and pediatric patients >= 5 years and weight >= 15 kg
Sirturo must be used as part of a combination regimen for pulmonary MDR‑TB

Step Therapy

Step Therapy / Alternatives

Coverage requires evidence that an effective alternative regimen cannot be used prior to approving Sirturo. Prescribers should document why other appropriate therapies (e.g., alternative regimens including bedaquiline alternatives when applicable) are not suitable.

Document prior use or trial and failure, intolerance, or contraindication to effective alternatives
Requests for XDR‑TB or treatment‑intolerant/nonresponsive MDR‑TB should include rationale for choosing Sirturo

Documentation Required

Required Clinical Documentation

Required clinical documentation must demonstrate the patient meets the FDA‑approved indication and that Sirturo will be given as part of combination therapy. Include supporting clinical records and rationale.

Diagnosis of pulmonary MDR‑TB (or XDR‑TB / treatment‑intolerant or nonresponsive MDR‑TB) with relevant microbiology/culture results
Age >= 5 years and weight >= 15 kg
Treatment plan showing Sirturo is part of a multidrug combination regimen (e.g., with pretomanid and linezolid when applicable)
Documentation that an effective alternative regimen cannot be used (prior therapy, intolerance, contraindication, or resistance data)
Relevant clinical notes, prior medication history, and any prior authorization or specialty pharmacy documentation

Denial Risk

Denial Triggers

Requests may be denied if Sirturo is not being prescribed as part of combination therapy for pulmonary MDR‑TB, if patient does not meet the FDA indication (age/weight), or when an effective alternative regimen exists that has not been tried or is not contraindicated.

Denial triggers: monotherapy use, treatment for drug‑sensitive TB, latent TB, extra‑pulmonary TB, or infections due to non‑tuberculous mycobacteria
Denial triggers: lack of documentation that alternatives are ineffective or contraindicated

Key Definitions

MDR-TB — definition and key points

TermMDR-TB (pulmonary multi-drug resistant tuberculosis)

FDA-approved indicationSirturo (bedaquiline) indicated as part of combination therapy for pulmonary MDR-TB in patients ≥5 years and ≥15 kg

Use restrictionReserve Sirturo for use when an effective treatment regimen cannot otherwise be provided

Not indicated forDrug-sensitive TB, latent Mycobacterium tuberculosis infection, extra‑pulmonary TB, infections caused by non‑tuberculous mycobacteria; safety/efficacy in HIV‑infected MDR‑TB patients not established

XDR‑TB / treatment‑intolerant MDR‑TB (off‑label combination)

TermXDR-TB / treatment‑intolerant or nonresponsive MDR‑TB

Off‑label regimen describedCombination regimen with pretomanid and linezolid (Zyvox) for pulmonary XDR‑TB or treatment‑intolerant/nonresponsive MDR‑TB

Coverage conditionWhen used for XDR or treatment‑intolerant/nonresponsive MDR‑TB, Sirturo must be prescribed as part of the combination with pretomanid and linezolid

Policy contextThis use is listed as an off‑label combination in the policy and included as an authorization criterion for such cases