CurrentNeighborhood Health Plan of Rhode IslandPolicy 1666-A

Xalkori (crizotinib) coverage policy

Defines prior authorization criteria, covered indications, documentation requirements, and authorization durations for Xalkori (crizotinib) across FDA-approved and compendial uses for commercial members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXalkori (crizotinib) coverage policy

Policy CodePolicy 1666-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of ALK, ROS1, or MET mutation/amplification status as applicable.

POLICY UPDATE CHANGES

No material clinical or coverage changes.

7Compendial uses listed

12Authorization duration (months)

3Major FDA indications

Coverage Summary

Coverage stance: covered_with_criteria. Defines prior authorization criteria, covered indications, documentation requirements, and authorization durations for Xalkori (crizotinib) across FDA-approved and compendial uses for commercial members. General coverage statement: Drugs indicated below are covered when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy. Requested drug must be Xalkori (crizotinib) (brand or generic, any dosage form or strength) and the member must have no exclusions to the prescribed therapy.

Initial Therapy Criteria

NSCLC - Initial authorization

Authorization of 12 months may be granted when ANY of the following are met:

ANY of the following

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

IMT - Initial authorization

Authorization of 12 months may be granted for ALK-translocation positive IMT as a single agent when ANY of the following are met:

ANY of the following

Member has uterine sarcoma and the disease is advanced, recurrent, metastatic, or inoperable
Member has a soft tissue sarcoma (not including uterine sarcoma)

ALCL - Initial authorization

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Member is a pediatric patient >= 1 year of age or young adult with relapsed or refractory systemic ALCL that is ALK-positive
Requested use is for initial palliative therapy or treatment of relapsed/refractory ALK-positive ALCL as a single agent

Histiocytic Neoplasms - Initial authorization

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Member has a histiocytic neoplasm with an ALK gene fusion
Requested use is for one of: symptomatic or relapsed/refractory Erdheim-Chester Disease (ECD); symptomatic or relapsed/refractory Rosai-Dorfman Disease; Langerhans Cell Histiocytosis (LCH)
Xalkori will be used as a single agent

Cutaneous Melanoma - Initial authorization

Authorization of 12 months may be granted for subsequent treatment when ALL of the following are met:

ALL of the following

The disease is ROS1 gene fusion-positive
The member had disease progression, an intolerance, or has a projected risk of progression with BRAF-targeted therapy (e.g., dabrafenib, encorafenib)
Requested medication will be used as a single agent

Continuation / Reauthorization Criteria

Continued therapy / Reauthorization

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

ANY of the following

NSCLC/ROS1 reauthorization: For ALK-rearrangement positive NSCLC and ROS1-rearrangement positive NSCLC: member requesting reauthorization has no evidence of unacceptable toxicity while on the current regimen
Other indications reauthorization: All other indications: member requesting reauthorization has no evidence of unacceptable toxicity or disease progression while on the current regimen

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required with mutation/amplification documentation

Submit documentation of the tumor's relevant biomarker status to support prior authorization.

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

Prior Authorization

Authorization duration

Authorizations (initial and reauthorization) are granted for 12 months as specified per indication.

Denial Risk

Denial for non-listed indications

Requests for indications not listed as FDA-approved or compendial uses are considered experimental/investigational and will be denied as not medically necessary.

Background

Background: Xalkori (crizotinib) is indicated for treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK- or ROS1-positive as detected by an FDA-approved test; for treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic ALK-positive anaplastic large cell lymphoma (ALCL); and for treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. Compendial uses include additional tumor types with ALK, ROS1, or MET alterations such as recurrent/advanced/metastatic ALK- or ROS1-rearrangement positive NSCLC, MET exon 14 skipping mutation-positive NSCLC, metastatic NSCLC with high-level MET amplification, IMT with ALK translocation, ALCL (relapsed or refractory ALK-positive), histiocytic neoplasms (Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman Disease), and ROS1 gene fusion-positive cutaneous melanoma.

Definitions: High-level MET amplification — As referenced in compendia; documentation required when applicable (policy does not define numeric cutoff).

OpenPayer

Xalkori (crizotinib) coverage policy

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Not Covered / Experimental

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History