CurrentCignaPolicy N/A

Infectious Disease - Pretomanid Prior Authorization Policy • Pretomanid tablets (Mylan)

Cigna prior authorization policy governing coverage of pretomanid tablets (Mylan) for treatment of pulmonary extensively drug-resistant or treatment-intolerant or nonresponsive multidrug-resistant tuberculosis in adults, including required combination therapy and prescriber specialty. Applies to health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyInfectious Disease - Pretomanid Prior Authorization Policy • Pretomanid tablets (Mylan)

Policy CodePolicy N/A

Change TypeAnnual Revision — No criteria changes

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approve for 9 months when criteria are met and ensure prescribing by or consultation with an infectious diseases specialist.

POLICY UPDATE CHANGES

Annual Revision noted 'No criteria changes.'

1Covered Indication (FDA-approved)

3Required combination drugs

18+Minimum patient age (years)

9 monthsTypical approved duration

Coverage Summary

Coverage stance: covered_with_criteria — Pretomanid tablets (Mylan) are covered when all policy criteria are met, including age, diagnosis, required combination therapy, and specialist prescribing/consultation. Scope: Cigna prior authorization policy governing pretomanid for treatment of pulmonary extensively drug-resistant tuberculosis, treatment-intolerant tuberculosis, or nonresponsive multidrug-resistant tuberculosis in adults, requiring use in combination with bedaquiline (Sirturo) and linezolid and specialist involvement. Coverage synopsis: Pretomanid is indicated as part of a combination regimen with bedaquiline and linezolid for adults with pulmonary XDR-TB or treatment-intolerant or nonresponsive MDR-TB; it is not indicated for drug-sensitive TB, latent infection, extrapulmonary TB, or MDR-TB that is not treatment-intolerant or nonresponsive. Typical approved duration is 9 months when criteria are met, consistent with the policy’s FDA-approved indication and treatment-duration references.

Key Policy Facts

Minimum patient age18+ years

Required combination drugs3 (bedaquiline, linezolid, pretomanid)

Typical approved duration9 months (approve for 9 months when criteria met)

Covered indicationFDA‑approved: pulmonary XDR, treatment‑intolerant, or nonresponsive MDR tuberculosis in adults

Last review date2024-12-11

Policy statusCURRENT

Initial Therapy Criteria (FDA-Approved Indication)

FDA-Approved Indication - Tuberculosis (Approval for 9 months)

Approve for 9 months if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

Patient is ≥ 18 years of age
ONE of
- Patient has extensively drug resistant tuberculosis
- Patient has treatment-intolerant tuberculosis
- Patient has nonresponsive multidrug-resistant tuberculosis
Pretomanid is prescribed in combination with Sirturo (bedaquiline tablets) and linezolid tablets or oral suspension (Zyvox, generic)
Medication is prescribed by or in consultation with an infectious diseases specialist
Approval requires specialist prescribing or consultation due to specialized skills and monitoring required

ref": "b1_0

title": "FDA-Approved Indication - Tuberculosis (Approval for 9 months)"]}

Provider Actions and Authorization Rules

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Pretomanid; approvals provided for indicated duration (approve for 9 months when criteria met).

Documentation Required

Specialist involvement required

Pretomanid must be prescribed by or in consultation with an infectious diseases specialist; documentation should support specialist involvement.

Billing Rule

Approval duration definition

When approval is authorized in months, 1 month is equal to 30 days; approvals are provided for the duration noted in the policy.

Clinical Evidence & Guidance

Evidence: Prescribing information: Mylan Pretomanid tablets, November 2024. Guideline: WHO consolidated guidelines on drug-resistant TB treatment, 2022. Note: Approval is based on limited clinical safety and efficacy data and applies to a limited population, as stated in the policy.

Background

Pretomanid is a nitroimidazole indicated as part of a combination regimen with Sirturo (bedaquiline) and linezolid (tablets or oral suspension) for the treatment of pulmonary extensively drug-resistant tuberculosis or treatment-intolerant or nonresponsive multidrug-resistant tuberculosis in adults. Approval of this indication is based on limited clinical safety and efficacy data and is for a limited and specific population of patients. Pretomanid is not indicated for drug-sensitive TB, latent M. tuberculosis infection, extrapulmonary TB, or MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy. The prescribing information notes a total treatment duration with pretomanid, bedaquiline, and linezolid of 26 weeks, and WHO guidance reports regimen durations containing this combination ranging from 6 to 9 months.

Treatment-intolerant tuberculosis: Not explicitly defined in the policy; the term implies an inability to tolerate standard therapy per the prescribing guidance and is used to identify patients for whom the pretomanid-containing regimen is indicated.