CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Crizotinib (Xalkori) coverage

Coverage and prior authorization criteria for Xalkori (crizotinib) for FDA-approved and compendial oncology indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCrizotinib (Xalkori) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of relevant molecular test results (ALK, ROS1, MET) to request up to a 12-month approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration for approved indications

FDA-approved + compendialindications considered covered when criteria met

ALK, ROS1, METmolecular test requirements referenced for documentation

Coverage and Medical Necessity Criteria

Initial therapy — FDA-approved and compendial indications

Authorization of 12 months may be granted when indication-specific criteria are met

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ALK- or ROS1-positive NSCLC: Member has recurrent, advanced, or metastatic ALK-positive NSCLC, ROS1-positive NSCLC, NSCLC with high-level MET amplification, or MET exon 14 skipping mutation-positive NSCLC and Xalkori will be used as a single agent.

Inflammatory Myofibroblastic Tumor (IMT): Member has unresectable, recurrent, or refractory ALK-positive IMT and Xalkori will be used as a single agent.

Anaplastic Large Cell Lymphoma (ALCL): Member has relapsed or refractory ALK-positive ALCL or is receiving initial palliative therapy; Xalkori will be used as a single agent.

Histiocytic Neoplasms: Member has a symptomatic or relapsed/refractory histiocytic neoplasm (e.g., Erdheim-Chester Disease, Rosai-Dorfman Disease, Langerhans Cell Histiocytosis) with an ALK gene fusion and Xalkori will be used as a single agent.

Cutaneous Melanoma (ROS1-positive): Disease is ROS1-positive; member had disease progression, intolerance, or has a projected risk of progression with BRAF-targeted therapy; and the requested medication will be used as a single agent.

Continuation / Reauthorization

Continued treatment may be authorized

Reauthorization for NSCLC: Continued treatment for ALK-positive or ROS1-positive NSCLC may be authorized for 12 months when there is no evidence of unacceptable toxicity while on the current regimen.

Reauthorization for all other indications: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Billing, Codes, and Authorization Duration

No explicit billing codes providedmixed

No codes listed

Authorization duration

Authorization duration12 months

When appliedInitial authorization for listed indications (e.g., ALK- or ROS1-positive NSCLC, MET-altered NSCLC, IMT, ALCL, histiocytic neoplasms, ROS1-positive cutaneous melanoma)

ReauthorizationContinued treatment may be authorized for 12 months when there is no evidence of unacceptable toxicity (and for non-NSCLC indications, no disease progression)

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals for covered indications are typically issued for up to 12 months.

Prior authorization required for all indications listed in the policy.
Typical approval duration: 12 months.

Step Therapy

Step / Sequence Requirement for Cutaneous Melanoma

For cutaneous melanoma, use is limited to ROS1-positive disease AND only after progression on, intolerance to, or projected risk of progression with BRAF-targeted therapy (for example dabrafenib, encorafenib). The requested agent must be used as a single agent.

Indication: unresectable or metastatic cutaneous melanoma with documented ROS1-positivity.
Step requirement: patient must have disease progression, intolerance, or projected risk of progression with BRAF-targeted therapy prior to approval.
Administration: single-agent use only.

Documentation Required

Required Molecular Test Results

Submit documentation of the applicable molecular test results to support the requested indication. Lack of required molecular evidence may result in denial.

Required test results (when applicable): ALK mutation or translocation status; ROS1 mutation status; MET exon 14 skipping mutation status; or high-level MET amplification status.
Provide laboratory/reports demonstrating tumor positivity for the specific biomarker corresponding to the requested indication.

Denial Risk

Experimental / Investigational Exclusions

Use for indications not listed as compendial or otherwise specified in the policy is considered experimental/investigational and is not medically necessary.

Examples of covered compendial uses are detailed elsewhere in the policy (e.g., select ALK-positive, ROS1-positive, MET-altered tumors, certain histiocytic neoplasms, cutaneous melanoma as specified).
All other indications are considered experimental/investigational and will be denied as not medically necessary.

Key Test and Biomarker Definitions

ALK-positive definition

DefinitionTumors with anaplastic lymphoma kinase (ALK) gene rearrangement as detected by an FDA-approved test

Documentation requiredSubmit ALK mutation or translocation status to initiate prior authorization review

Relevant indicationsIncludes metastatic NSCLC, ALK-positive ALCL, ALK-positive IMT, and ALK fusion–positive histiocytic neoplasms when criteria met

ROS1-positive definition

DefinitionTumors with ROS1 gene rearrangement as detected by an FDA-approved test

Documentation requiredSubmit ROS1 mutation/rearrangement status to initiate prior authorization review

Relevant indicationsIncludes ROS1-positive metastatic NSCLC and ROS1-positive cutaneous melanoma (compendial) when criteria met

MET exon 14 skipping / high-level MET amplification definition

DefinitionSpecific MET genomic alterations: exon 14 skipping mutation or high-level MET amplification documented by testing

Documentation requiredSubmit MET exon 14 skipping mutation status or high-level MET amplification status where applicable to initiate prior authorization review

Relevant indicationNSCLC with MET exon 14 skipping mutation–positive or NSCLC with high-level MET amplification (compendial)

Clinical Background

Crizotinib (Xalkori) is a targeted oral kinase inhibitor used for tumors with rearrangements or alterations in kinases such as ALK, ROS1, and certain MET genomic changes. The policy’s compendial list includes indications where molecular alteration is required (for example, ALK translocation, ROS1 rearrangement, MET exon 14 skipping, or high‑level MET amplification) and specific rare tumor types (e.g., inflammatory myofibroblastic tumor with ALK translocation, anaplastic large cell lymphoma, and histiocytic neoplasms such as Erdheim‑Chester disease, Rosai‑Dorfman disease, and Langerhans cell histiocytosis). Authorization is limited to these FDA‑approved and compendial uses; uses outside this list are considered experimental/investigational and not medically necessary.