CurrentMass General Brigham Health PlanPolicy N/A

Pretomanid prior authorization (coverage criteria)

This policy governs prior authorization, coverage criteria, and quantity/term limits for pretomanid under the pharmacy benefit for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPretomanid prior authorization (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2023

Next Review Date

Key ActionObtain prior authorization and document diagnosis, age, and planned use with bedaquiline and linezolid (or show member is stable on pretomanid if new to plan).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial approval duration

bedaquiline + linezolidrequired combination regimen

pulmonary XDR/MDR-TBdiagnosis required

prior authauthorization pathway

Coverage Criteria for Pretomanid

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Initial Authorization: Member is ≥ 18 years old; member has a diagnosis of pulmonary extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant tuberculosis; and pretomanid will be used in combination with bedaquiline and linezolid.age >= 18

Authorization may alternatively be granted for members new to the plan who are currently receiving and stable on pretomanid (excluding samples or manufacturer patient assistance program supply).

Continuation Therapy / Reauthorization

Covered for continuation when ALL of the following are met

Continuation/Reauthorization: Physician documents improvement in the member's condition.clinical improvement documented

Initial approvals will be for 6 months.

Use of samples or pretomanid supplied through the manufacturer's patient assistance program is excluded from consideration for authorization when the member is new to the plan. Authorization for members new to the plan may only be granted if the member is currently receiving and is stable on pretomanid, and the medication was not obtained as samples or via a manufacturer patient assistance program.

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior authorization required (stability exception allowed)

Prior authorization is required for pretomanid. Authorization may be granted for members who are new to the plan if they are currently receiving and stable on pretomanid (excluding product obtained as samples or via manufacturer's patient assistance programs) or when all specified clinical criteria and combination regimen are documented.

Step Therapy

No step therapy edits

Step therapy does not apply to pretomanid; no step edits are specified in this policy.

Documentation Required

Required documentation for authorization and reauthorization

Provider must submit documentation showing either that the member is currently receiving and stable on pretomanid (for members new to the plan) or, for new starts, documentation that all coverage criteria are met.

Evidence the member is currently receiving and is stable on pretomanid (samples or manufacturer patient assistance program supply excluded)
Member is ≥ 18 years old
Diagnosis of pulmonary extensively drug‑resistant, treatment‑intolerant, or nonresponsive multidrug‑resistant tuberculosis
Plan to use pretomanid in combination with bedaquiline and linezolid
For reauthorization: physician documentation of clinical improvement

Denial Risk

Denial triggers — insufficient or missing documentation

Requests may be denied if required documentation is not provided or does not demonstrate the required diagnosis, age, appropriate combination therapy, or that the member is stable on pretomanid when new to the plan.

Insufficient documentation of current stable therapy for members new to the plan (or use of samples/PAP supply)
Missing or inadequate documentation of age (≥ 18 years)
No documentation of indicated diagnosis (pulmonary XDR / treatment‑intolerant or nonresponsive MDR‑TB)
No documentation that pretomanid will be used with bedaquiline and linezolid

Background

Pretomanid is an antimycobacterial agent included in combination regimens for certain resistant forms of pulmonary tuberculosis. Authorization language in the policy clarifies that approval may be granted for members who are already receiving and are stable on pretomanid; however, such consideration excludes courses provided as samples or those obtained through the manufacturer's patient assistance program.

Revision History

2023-01-01policy_effectiveLatest

Policy effective date for the current coverage criteria for pretomanid (safinamide).

2022-09-21review

Reviewed at September P&T; separated Commercial/Exchange vs MassHealth policies with no clinical updates noted in the document preview.

2020-09-01policy_effective

Prior revision became effective 09/01/2020 following review at 07/22/2020 P&T meeting.

2020-07-22review

Reviewed at P&T meeting (07/22/2020) as recorded in the policy review history.