CurrentNeighborhood Health Plan of Rhode IslandPolicy 1666-A

Xalkori

Defines coverage, prior authorization documentation, and authorization durations for Xalkori (crizotinib) across FDA-approved and NCCN-compendial indications including ALK- or ROS1-positive NSCLC, ALK-positive ALCL, ALK-positive IMT, histiocytic neoplasms, and select melanoma and MET-altered NSCLC indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXalkori

Policy CodePolicy 1666-A

Change TypeClarified

Effective Date

Next Review Date

Key ActionSubmit ALK, ROS1, MET exon 14 skipping, or high-level MET amplification status as applicable to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

Indications and compendial uses listed with authorization duration of 12 months and required documentation for biomarker status.

7Primary Indications Listed (FDA + Compendia)

1Policy Reference Number

Coverage Summary & Scope

Defines coverage for Xalkori (crizotinib) across FDA-approved and NCCN-compendial indications including ALK- or ROS1-positive metastatic NSCLC, ALK-positive ALCL, ALK-positive IMT, histiocytic neoplasms, select cutaneous melanoma and MET-altered NSCLC. Prior authorization is required with submission of relevant biomarker documentation (ALK, ROS1, MET exon 14 skipping, or high-level MET amplification). When approval criteria are met, prior authorization may be granted for 12 months; reauthorization requires absence of unacceptable toxicity (for ALK- and ROS1-NSCLC and other indications) and absence of disease progression (for other indications) as specified.

Prior Authorization & Documentation Requirements

Documentation Required

Required biomarker documentation for PA

Submit ALK mutation or translocation status, ROS1 mutation status, MET exon 14 skipping mutation status, or high-level MET amplification status (where applicable) to initiate prior authorization review.

ALK mutation or translocation status
ROS1 mutation status
MET exon 14 skipping mutation status
High-level MET amplification status

Prior Authorization

Prior authorization required with 12-month approvals

Prior authorization may be granted for 12 months for covered indications when the member meets the listed approval criteria. Reauthorization requires no evidence of unacceptable toxicity (for ALK- and ROS1-rearrangement positive NSCLC and for other indications requesting reauthorization) and no evidence of disease progression for other indications as specified.

Initial approvals may be issued for 12 months for covered indications when criteria are met.
Reauthorization for ALK- and ROS1-rearrangement positive NSCLC requires absence of unacceptable toxicity on current regimen.
Reauthorization for other indications requires absence of unacceptable toxicity and no disease progression while on the current regimen.

Drug Background

Xalkori (crizotinib) is indicated for treatment of adult patients with metastatic NSCLC whose tumors are ALK- or ROS1-positive, for pediatric patients and young adults with relapsed or refractory systemic ALK-positive anaplastic large cell lymphoma (ALCL), and for adult and pediatric patients with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumor (IMT). Compendial uses include additional tumor types such as cutaneous melanoma, recurrent/advanced/metastatic ALK- or ROS1-rearranged NSCLC, MET exon 14 skipping–positive NSCLC, metastatic NSCLC with high-level MET amplification, ALK-translocation IMT, relapsed/refractory ALK-positive ALCL, and histiocytic neoplasms (Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman Disease). Safety in older adults with relapsed/refractory ALK-positive ALCL has not been established.

Revision History

clarifiedLatest

Indications and compendial uses listed with authorization duration of 12 months.

clarifiedLatest

Required documentation: submission of ALK mutation or translocation status, ROS1 mutation status, MET exon 14 skipping mutation status, or high-level MET amplification status to initiate prior authorization review.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXalkori

Policy CodePolicy 1666-A

Change TypeClarified

Effective Date

Next Review Date

Key ActionSubmit ALK, ROS1, MET exon 14 skipping, or high-level MET amplification status as applicable to initiate prior authorization review.

SourceLink

On This Page

OpenPayer

Xalkori

Coverage Summary & Scope

Initial Therapy Criteria (Covered Indications)

Continuation / Reauthorization Criteria

Unproven / Not Medically Necessary

Prior Authorization & Documentation Requirements

Applicable Codes

Supporting Evidence & References

Drug Background

Revision History