CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Alunbrig (brigatinib) — Drug Policy (coverage criteria)

Defines accepted indications, inclusion and exclusion criteria, and utilization management requirements for brigatinib (Alunbrig) for members receiving care through the plan; applies to provider requests for authorization and reimbursement processing.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlunbrig (brigatinib) — Drug Policy (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateMay 8, 2024

Key ActionSubmit prior authorization with documentation of ALK rearrangement and supporting evidence (FDA label, CMS compendia, NCCN/ASCO or peer-reviewed literature).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

First-line or subsequentIndication stance for ALK-positive metastatic NSCLC

Max 180 mgDose ceiling

90/60/30Monthly tablet limits

2024-05-31Effective date

Coverage Criteria for Brigatinib (Alunbrig)

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Initial and Continuation Therapy

Covered when ALL of the following are met for NSCLC:

Eligibility for brigatinib (Initial or Continuation): Member has recurrent/metastatic non-small cell lung cancer with documented positive ALK rearrangement confirmed by a standard test; brigatinib is requested as single-agent therapy for first-line or subsequent therapy.

Supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines or acceptable peer-reviewed literature

Continuation-specific criteria: For continuation requests: the requested medication was used within the last year; the member has not experienced disease progression or intolerance to the requested medication; and no additional medications are being added to the continuation request.

Continuation exemption per policy section II.A

Dosing limitations: Single dose must not exceed 180 mg; monthly tablet limits must not exceed 90 tablets of 30 mg, 60 tablets of 90 mg, or 30 tablets of 180 mg.single dose <= 180 mg; monthly tablets <= specified limits

Exclusion criteria list dosing caps

The policy excludes coverage for Alunbrig (brigatinib) in several circumstances. Requests will be denied if the member has experienced disease progression while receiving brigatinib or if brigatinib is being used concurrently with other anticancer therapies. Coverage is also excluded when there is a lack of documentation of ALK rearrangement confirmed by a standard test. Dosing that exceeds the single-dose limit of 180 mg or that results in exceeding the monthly tablet limits (90 tablets of 30 mg, 60 tablets of 90 mg, or 30 tablets of 180 mg) will be denied. Finally, use that is investigational or off-label without sufficient supporting evidence is not approvable under this policy.

Use of brigatinib for investigational or off-label indications is considered not medically necessary when the available evidence is insufficient or not generally accepted by the medical community. The policy defines insufficient evidence to include situations where the patient or cancer characteristics are not adequately represented in the published evidence, the therapeutic regimen under study is not adequately represented, reported outcomes are not clinically meaningful (for example, not meeting commonly accepted thresholds such as an ASCO-recommended hazard ratio or survival benefit), study design is inappropriate to address the question, or evidence is limited to uncontrolled case reports or meeting abstracts without a full peer-reviewed publication. Such uses must be supported by CMS-recognized compendia or acceptable peer-reviewed literature to be considered approvable.

Initial Authorization Criteria

Initial therapy

Initial authorization is permitted when ALL of the following are met:

Initial therapy criteria: Diagnosis of recurrent/metastatic non-small cell lung cancer with documented ALK rearrangement confirmed by a standard test; brigatinib is requested as single-agent therapy for first-line or subsequent therapy.

See Indications (NSCLC) section

Supporting documentation: Provider submits documentation supporting use per FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature.

Per Purpose: required supporting evidence sources

Dose compliance: Requested dosing does not exceed single-dose limit of 180 mg and does not exceed monthly tablet limits (90 of 30 mg, 60 of 90 mg, or 30 of 180 mg).single dose <= 180 mg; monthly tablets <= specified limits

Dosing limits listed in Exclusion Criteria

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Alunbrig (brigatinib). Continuation requests may be authorized when the member has been receiving brigatinib within the past year without disease progression or intolerance, and no additional agents are being added to the regimen.

Prior authorization required
Continuation allowed if prior criteria met

Note

Policy Allows Single-Agent Brigatinib

Alunbrig (brigatinib) is permitted as a single-agent therapy for members with recurrent or metastatic non-small cell lung cancer (NSCLC) who have a documented ALK rearrangement. Brigatinib may be used as first-line therapy or as subsequent therapy; no step therapy or prior trial of another ALK inhibitor is required by this policy.

Single-agent brigatinib allowed for ALK-positive recurrent/metastatic NSCLC
Allowed in first-line or subsequent lines of therapy
No step therapy required

Documentation Required

Required Supporting Documentation

The provider must supply documentation supporting the medical necessity of brigatinib. Acceptable sources include FDA-approved labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS standards. Documentation must include confirmation of ALK rearrangement by a standard test, clinical indication (recurrent/metastatic NSCLC), prior treatment history if applicable, current dosing and regimen, and evidence of absence of disease progression or intolerance for continuation requests.

Provide FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature
Confirm ALK rearrangement with standard testing (report or test result)
Clinical history documenting diagnosis of recurrent/metastatic NSCLC
Prior treatment history and rationale for brigatinib selection
Current prescribed dose and tablet strength; dosing does not exceed single-dose limit of 180 mg
For continuation: evidence brigatinib was used within last year and no disease progression or intolerance

Denial Risk

Triggers for Denial

Requests will be denied if exclusion criteria are met, including disease progression on brigatinib, concurrent use with other anticancer therapies, lack of documented ALK rearrangement, dosing beyond single-dose or monthly tablet limits, or investigational/off-label use lacking sufficient evidence as defined by CMS compendia or acceptable peer-reviewed literature.

Progression while receiving brigatinib (denial)
Concurrent anticancer therapies (denial)
No documentation of ALK rearrangement (denial)
Dosing exceeds single-dose limit of 180 mg or monthly tablet limits (denial)
Investigational or off-label indications without sufficient supporting evidence (denial)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlunbrig (brigatinib) — Drug Policy (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateMay 8, 2024

Key ActionSubmit prior authorization with documentation of ALK rearrangement and supporting evidence (FDA label, CMS compendia, NCCN/ASCO or peer-reviewed literature).

SourceLink

On This Page

OpenPayer

Alunbrig (brigatinib) — Drug Policy (coverage criteria)

Coverage Criteria for Brigatinib (Alunbrig)

Initial Authorization Criteria

Continuation Authorization Criteria

Provider Actions and Authorization Requirements

Quantity Limits and Dosing

Definitions and Test Requirements

Background