CurrentNeighborhood Health Plan of Rhode IslandPolicy 2787-A

Lorbrena (lorlatinib)

Coverage policy for lorlatinib (Lorbrena) including FDA-approved and compendial indications, documentation required for prior authorization, authorization durations, and reauthorization criteria. Applies to listed oncology indications with specified molecular testing and prior therapy requirements for certain uses.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLorbrena (lorlatinib)

Policy CodePolicy 2787-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionChart documentation indicating ALK mutation status or ROS1 rearrangement status must be submitted to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material changes — policy has no material clinical/coverage changes.

12 monthsTypical authorization duration

MultipleCovered indications

Molecular testingRequired documentation type

Coverage Summary

Policy number 2787-A for Lorbrena (lorlatinib) has a coverage stance of covered_with_criteria for FDA-approved and compendial oncology indications. Typical authorizations are for 12 months when specified clinical and documentation criteria are met. The policy specifically covers the FDA-approved indication for adult patients with metastatic NSCLC that is ALK-positive and multiple compendial uses (including ROS1-positive NSCLC after progression on listed agents, IMT with ALK translocation, uterine and soft tissue sarcomas, Erdheim-Chester disease with ALK fusion, ALK-positive large B-cell lymphoma, pediatric diffuse high-grade glioma with ALK rearrangement under specified conditions, and ALK-positive ALCL). Indications not listed in the coverage criteria are considered investigational/experimental and not medically necessary.

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Covered Indications / Initial Authorization

Authorization of 12 months may be granted when criteria below are met:

ANY of the following

Compendial single-agent indications
- FDA-approved ALK-positive metastatic NSCLC: FDA-approved indication for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
  Requires documentation of ALK mutation status.
- Inflammatory myofibroblastic tumor (IMT) with ALK translocation; authorization when ALK-positive IMT as a single agent.
  See subcriteria for uterine and soft tissue sarcoma below.
- Recurrent/advanced/metastatic ALK-rearranged NSCLC (compendial): Recurrent, advanced, or metastatic NSCLC with ALK rearrangement-positive tumors as single-agent therapy.
  Included as compendial use; documentation of ALK status required.
- ROS1-rearrangement positive NSCLC after progression: ROS1 rearrangement-positive recurrent, advanced, or metastatic NSCLC following disease progression on crizotinib, entrectinib, repotrectinib, or taletrectinib.
  Requires documentation of ROS1 rearrangement and prior progression on listed agents.
- Uterine sarcoma (compendial): Uterine sarcoma (as part of compendial uses) — listed as a possible compendial indication.
  Specific authorization criteria for uterine sarcoma are listed under IMT section.
- Soft tissue sarcoma (non-uterine): Soft tissue sarcoma (not including uterine sarcoma) — listed as compendial use.
  Authorization as single-agent where applicable.
- Erdheim-Chester disease with ALK fusion — authorization as single-agent.
  Requires documentation of ALK fusion.
- ALK-positive large B-cell lymphoma (relapsed/refractory): ALK-positive large B-cell lymphoma (relapsed or refractory) — authorization as single-agent.
  Documentation of ALK-positivity required.
- Pediatric diffuse high-grade glioma with ALK-rearrangement — authorization when either: disease is recurrent/progressive and not IDH-mutant with 1p/19q codeletion oligodendroglioma or IDH-mutant astrocytoma; OR request is for adjuvant treatment and disease is NOT diffuse midline, H3 K27-altered, or pontine location.
  Pediatric-specific molecular and location exclusions apply.
- ALK-positive anaplastic large cell lymphoma (ALCL) relapsed/refractory — authorization as single-agent.
  Documentation of ALK-positivity required.

Non‑Small Cell Lung Cancer (NSCLC) — Specific Criteria

Non-Small Cell Lung Cancer (NSCLC) — Specific Criteria

Authorization of 12 months may be granted:

ANY of the following

ALK rearrangement-positive NSCLC (including brain mets): For ALK rearrangement-positive recurrent, advanced, or metastatic NSCLC (including brain metastases) as single-agent.
Documentation of ALK-positive status required; duration 12 months.
ROS1-positive NSCLC following progression
- ROS1 rearrangement-positive disease: Disease is ROS1 rearrangement-positive.
- Prior progression on listed agents: Disease has progressed on any of the following: crizotinib, entrectinib, repotrectinib, or taletrectinib.

Inflammatory Myofibroblastic Tumor (IMT) — Specific Criteria

Authorization of 12 months may be granted for ALK-positive IMT as a single agent when either criterion below is met:

IMT — uterine vs soft tissue

Uterine sarcoma (IMT) criterion: The member has uterine sarcoma and the disease is advanced, recurrent, metastatic, or inoperable.
Soft tissue sarcoma (non-uterine) criterion: The member has a soft tissue sarcoma (not including uterine sarcoma).

Additional Covered Indications

Erdheim-Chester Disease; Diffuse Large B-Cell Lymphoma; Pediatric Diffuse High-Grade Glioma; Anaplastic Large Cell Lymphoma (ALCL)

Authorization of 12 months may be granted when:

Erdheim-Chester Disease: Disease is ALK-positive Erdheim-Chester disease.

Diffuse Large B-Cell Lymphoma: Relapsed or refractory ALK-positive large B-cell lymphoma.

Pediatric Diffuse High-Grade Glioma

Recurrent/progressive molecular exclusions: Disease is recurrent or progressive and the member does not have IDH-mutant and 1p/19q codeleted oligodendroglioma or IDH-mutant astrocytoma.
Adjuvant treatment location exclusions: Request is for adjuvant treatment and the member does not have disease that is diffuse midline, H3 K27-altered or pontine location.

Anaplastic Large Cell Lymphoma (ALCL): Relapsed/refractory ALK-positive ALCL as a single agent.

Reauthorization / Continued Treatment Criteria

Reauthorization / Continued Treatment

Authorization of 12 months may be granted for continued treatment when:

Reauthorization criteria: There is no evidence of unacceptable toxicity while on the current regimen.

No disease progression for listed indications: For indications listed in coverage criteria, there is no evidence of disease progression while on the current regimen.

Applies to members requesting reauthorization for an indication listed in the coverage criteria.

Provider Actions

Documentation Required

Molecular testing documentation required

Chart documentation indicating ALK mutation status or ROS1 rearrangement status (where applicable) must be submitted to initiate prior authorization review.

Documentation of ALK mutation/rearrangement is required to initiate prior authorization for ALK-positive indications.
Documentation of ROS1 rearrangement is required for ROS1-specific NSCLC indication prior authorization.

Prior Authorization

Prior authorization required

Prior authorization required; initial and reauthorization approvals are for up to 12 months when clinical criteria are met.

Authorization duration: approvals (initial and reauthorization) may be granted for up to 12 months when criteria are met.
Submit required clinical documentation (including molecular testing where applicable) to demonstrate criteria are met for the requested indication.

Denial Risk

Not medically necessary for other indications

All other indications not listed are considered experimental/investigational and not medically necessary and may be denied.

Indications not listed in the covered FDA-approved or compendial uses are considered investigational and may be denied as not medically necessary.

Background

Lorbrena (lorlatinib) is a targeted ALK inhibitor with FDA approval for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive as detected by an FDA-approved test. The policy also lists several compendial uses including ROS1-positive NSCLC following progression on specified agents, inflammatory myofibroblastic tumor (IMT) with ALK translocation (including uterine and soft tissue sarcoma contexts), Erdheim-Chester disease with ALK fusion, ALK-positive large B-cell lymphoma, pediatric diffuse high-grade glioma with ALK rearrangements under defined conditions, and ALK-positive anaplastic large cell lymphoma (ALCL). All other unlisted indications are considered investigational/experimental and not medically necessary. Chart documentation of ALK mutation status or ROS1 rearrangement status is required to initiate prior authorization review.

ALK-positive: Tumors with anaplastic lymphoma kinase (ALK) rearrangement or translocation as detected by an FDA-approved test or appropriate molecular testing.

ROS1 rearrangement-positive: Tumors with ROS1 rearrangement as detected by an appropriate test; required for ROS1-specific indication.

Revision History

statusLatest

Policy status: CURRENT. No dated revision history provided; policy marked CURRENT. Coverage: Lorbrena (lorlatinib) covered with criteria for FDA-approved ALK-positive metastatic NSCLC and multiple compendial indications (ROS1-positive NSCLC after progression on specified agents; IMT with ALK translocation including uterine and soft tissue sarcoma; Erdheim‑Chester disease with ALK fusion; ALK‑positive large B‑cell lymphoma; pediatric diffuse high‑grade glioma with ALK rearrangement under specified conditions; ALK‑positive ALCL). Prior authorization with documentation of ALK or ROS1 status is required; typical authorization duration 12 months. All other indications considered investigational.