CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lorbrena (lorlatinib) — Coverage Criteria for ALK- and ROS1‑positive Cancers

Policy governing coverage and prior authorization requirements for lorlatinib (Lorbrena) for adult patients with ALK- or ROS1-positive metastatic non-small cell lung cancer and ALK-positive inflammatory myofibroblastic tumor for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLorbrena (lorlatinib) — Coverage Criteria for ALK- and ROS1‑positive Cancers

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit chart documentation showing ALK mutation or ROS1 rearrangement status to initiate prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

ALK-positive NSCLCFDA-approved indication

ROS1 after progressioncompendial ROS1 requirement

IMT ALK-positivecompendial IMT

Coverage and Medical Necessity Criteria

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Covered Indications

Covered when ALL of the following are met for each indication group

FDA-approved NSCLC: Adult patient with metastatic non-small cell lung cancer (NSCLC) with ALK-positive tumor as detected by an FDA-approved test

FDA-approved indication

Compendial ROS1 NSCLC: Recurrent, advanced or metastatic NSCLC that is ROS1 rearrangement-positive AND disease has progressed on ceritinib, crizotinib, or entrectinib

Compendial use requires prior ROS1 TKI progression

Compendial IMT: Inflammatory myofibroblastic tumor (IMT) with ALK translocation

Compendial single-agent use

Reauthorization

Reauthorization criteria

NSCLC reauthorization: No evidence of unacceptable toxicity while on the current regimen

Authorization of 12 months may be granted for continued treatment

IMT reauthorization: No evidence of unacceptable toxicity or disease progression while on the current regimen

Authorization of 12 months may be granted for continued treatment

All uses of lorlatinib (Lorbrena) outside the FDA‑approved indication and the specific compendial situations listed in this policy are considered experimental/investigational and not medically necessary.

Use of lorlatinib for indications other than the FDA‑approved indication or the compendial uses described (single‑agent therapy for ALK‑rearranged NSCLC, ROS1‑rearranged NSCLC after progression on crizotinib, entrectinib, or ceritinib, and ALK‑translocated IMT) is not medically necessary.

Regimen	Indication	Coverage status
Single-agent lorlatinib
ALK-positive inflammatory myofibroblastic tumor (IMT) — single-agent
Authorization may be granted for 12 months for treatment of ALK-positive IMT as a single agent (see prior authorization requirements).

What Providers Must Submit / Prior Authorization Details

Prior Authorization

Authorization duration and indications

Authorization of up to 12 months may be granted for covered indications. For NSCLC, prior authorization may be approved for 12 months when used as single‑agent therapy for ALK‑rearrangement–positive recurrent, advanced, or metastatic NSCLC. For ROS1‑rearranged NSCLC, prior authorization for up to 12 months may be granted only when the disease has progressed on one of the following prior ROS1 TKIs: ceritinib, crizotinib, or entrectinib.

Authorization duration: 12 months (per approval)
Indications: ALK‑rearrangement positive recurrent/advanced/metastatic NSCLC; ROS1‑rearrangement positive recurrent/advanced/metastatic NSCLC after progression on listed ROS1 TKIs

Step Therapy

Prior ROS1 TKI required

For ROS1‑rearranged NSCLC, coverage as a compendial use requires prior progression on ceritinib, crizotinib, or entrectinib. Document prior therapy and progression in the medical record when submitting the prior authorization request.

Required prior ROS1 TKI(s): ceritinib, crizotinib, entrectinib
Documentation: chart notes showing prior ROS1 TKI use and disease progression

Documentation Required

Required diagnostic documentation

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

Submit pathology or molecular testing results confirming ALK or ROS1 rearrangement status

Denial Risk

Experimental/Investigational exclusions

Use of lorlatinib for indications other than FDA‑approved or listed compendial uses (ALK‑ or ROS1‑rearranged NSCLC and ALK‑positive IMT per policy) is considered experimental/investigational and not medically necessary.

Experimental/Investigational: any indication not explicitly FDA‑approved or listed as a compendial use in the policy

Permitted Line(s) of Therapy

salvage

ROS1 post-TKI: ROS1-rearranged NSCLC after progression on ceritinib, crizotinib, or entrectinib

Compendial requirement

first-line

ALK-positive metastatic NSCLC: Adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test

FDA-approved indication

Diagnostic and Biomarker Testing Requirements

ALK rearrangement / ALK translocation — biomarker requirement details

Required biomarkerPresence of an ALK rearrangement or ALK translocation documented by testing (ALK-positive status)

Applies to indicationsRequired for coverage of metastatic NSCLC (FDA‑approved) and for inflammatory myofibroblastic tumor (IMT) with ALK translocation (compendial)

Documentation neededChart documentation indicating ALK mutation/rearrangement or ALK translocation must be submitted to initiate prior authorization review

Authorization durationWhen criteria met, prior authorization may be granted for up to 12 months for ALK‑rearrangement positive recurrent, advanced or metastatic NSCLC and for ALK‑positive IMT (single‑agent)

ROS1 rearrangement — biomarker requirement details

Required biomarkerPresence of a ROS1 rearrangement confirmed by testing (ROS1‑positive)

Coverage limitationCoverage for ROS1‑rearranged NSCLC is compendial and limited to patients whose disease progressed on ceritinib, crizotinib, or entrectinib

Documentation neededChart documentation indicating ROS1 rearrangement status must be submitted to initiate prior authorization review

Authorization durationWhen compendial criteria are met, prior authorization may be granted for up to 12 months for ROS1‑rearranged NSCLC following required prior ROS1 TKI progression

ALK-positive — definition of ALK-positive

DefinitionTumors with anaplastic lymphoma kinase (ALK) rearrangement detected by an FDA‑approved test (for NSCLC) or ALK translocation (for IMT)

FDA implicationALK‑positive metastatic NSCLC detected by an FDA‑approved test is the FDA‑approved indication for lorlatinib

Compendial implicationALK rearrangement/translocation also supports compendial single‑agent use for IMT (ALK‑translocated inflammatory myofibroblastic tumor)

ROS1-positive — definition of ROS1-positive and limitation notes

DefinitionTumors with ROS1 rearrangement (ROS1‑positive)

Coverage limitationCoverage for lorlatinib in ROS1‑positive NSCLC is a compendial use and requires prior progression on ceritinib, crizotinib, or entrectinib