CurrentAvMedPolicy N/A

Bedaquiline (Sirturo) prior authorization and step-edit request

Form and criteria governing prior authorization for Sirturo (bedaquiline) for AvMed members, including documentation, eligibility, and quantity/length limits required for approval. Affects prescribers, pharmacists, and AvMed members requesting bedaquiline.

Policy Summary

PayerAvMed

PolicyBedaquiline (Sirturo) prior authorization and step-edit request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization/step-edit request form and provide required clinical documentation for approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthslength of authorization

6-month supplyquantity limit per course

188100 mg tablets

94020 mg tablets

>=2 yrs, >=8 kgminimum age/weight

Coverage Criteria for Sirturo (bedaquiline)

inv-01: Initial therapy criteria

Covered when ALL of the following are met:

age_weight: Member is 2 years of age or older and weighs at least 8 kg

chunk 3

DOT_enrollment: Member is enrolled in a DOT (Directly Observed Therapy) Program

chunk 3

specialist_prescriber: Medication is prescribed by or in consultation with an infectious disease specialist

chunk 3

diagnosis_resistance:

Policy Summary

PayerAvMed

PolicyBedaquiline (Sirturo) prior authorization and step-edit request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization/step-edit request form and provide required clinical documentation for approval.

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 Requirements and Submission Instructions

Prior Authorization

Form completion and signature required

Prescriber must complete and sign the prior authorization/step-edit request form. Provide member and prescriber information, drug details (form/strength, dosing schedule, length of therapy, diagnosis, ICD code if applicable, weight and date obtained), and office contact with phone and fax. Fax the completed form to 1-305-671-0200. If information is incomplete, incorrect, or illegible, authorization may be delayed or denied.

Fax number: 1-305-671-0200
Prescriber signature required (preprinted stamps not valid)
Include NPI, office contact name, phone and fax

Step Therapy

Step-edit/sample rule

Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes; initiation with free samples will not satisfy step requirements.

Documentation Required

Required supporting documentation

Submit documentation to support each checked clinical criterion. Required supporting documentation includes lab results, diagnostics, chart notes, and sputum culture demonstrating Mycobacterium tuberculosis with drug resistance. Specifically provide cultures for species identification and drug sensitivity testing and chart notes documenting resistance to at least isoniazid and rifampin (and possibly additional agents) when applicable.

Sputum culture for mycobacterium (species ID, drug sensitivity, genotyping)
Chart notes documenting Mycobacterium tuberculosis isolate and resistance profile
Lab results and diagnostics supporting listed clinical criteria

Denial Risk

Incomplete or illegible submission

Authorization can be delayed or request may be denied if the form information is not complete, correct, or legible, or if required documentation is missing. Ensure all clinical criteria boxes are completed and all supporting documents are attached.

Background

Bedaquiline (Sirturo) is indicated for treatment of pulmonary multidrug‑resistant tuberculosis (MDR‑TB). Approval requires laboratory confirmation or documentation of drug resistance — either a submitted sputum culture for Mycobacterium (which provides species identification and drug sensitivity testing) or chart notes/lab cultures demonstrating an isolate resistant to at least isoniazid and rifampin. Additionally, members must meet baseline eligibility such as being enrolled in Directly Observed Therapy (DOT) and meeting the minimum age/weight threshold of ≥ 2 years and ≥ 8 kg. Use of Sirturo should be verified in combination with pretomanid, linezolid and/or moxifloxacin when applicable, and samples used to initiate therapy do not satisfy step‑edit or prior authorization requirements.

Initial Therapy Criteria

inv-11: Initial therapy — Initial authorization requirements

Initial authorization requirements

age_weight: Member is >=2 years and >=8 kg

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DOT: Member enrolled in Directly Observed Therapy (DOT)

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specialist: Prescribed by or in consultation with an infectious disease specialist

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confirmed_MDR-TB: Either diagnosis of Pulmonary MDR-TB with sputum culture submitted OR chart notes/lab cultures documenting Mycobacterium tuberculosis isolate resistant to at least isoniazid and rifampin

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Rule	Details
Use of samples to initiate therapy	Use of samples to initiate therapy does not meet step edit/preauthorization criteria.
Verification of previous therapies	Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

OpenPayer

Bedaquiline (Sirturo) prior authorization and step-edit request

Coverage Criteria for Sirturo (bedaquiline)

Coding and Diagnostic Information

Provider Requirements and Submission Instructions

Background

Definitions

Initial Therapy Criteria

Step Therapy and Related Rules

Quantity and Supply Limits