CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xalkori (crizotinib) coverage

Defines prior authorization, coverage indications, and documentation requirements for crizotinib (Xalkori) for members when FDA‑approved or compendial indications and approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXalkori (crizotinib) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of ALK, ROS1, or MET biomarker status to initiate prior authorization for covered indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12authorization period (months)

3FDA‑approved major indications

7compendial uses listed

ALK/ROS1/METrequired biomarkers

Coverage Criteria for Crizotinib (Xalkori)

A. Non-Small Cell Lung Cancer (NSCLC)

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{

"operator":"any",

"children":[

{"text":"Member has recurrent, advanced or metastatic ALK-positive NSCLC and will be used as a single agent."},

{"text":"Member has recurrent, advanced or metastatic ROS1-positive NSCLC and will be used as a single agent."},

{"text":"Member has recurrent, advanced, or metastatic MET exon 14 skipping mutation-positive NSCLC and will be used as a single agent."},

Member has NSCLC with high-level MET amplification.

]

}

B. Inflammatory Myofibroblastic Tumor (IMT)

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

{

"operator":"any",

"children":[

{"text":"The member has uterine sarcoma and the disease is advanced, recurrent, metastatic, or inoperable."},

The member has a soft tissue sarcoma (not including uterine sarcoma).

]

}

C. Anaplastic Large Cell Lymphoma (ALCL)

Authorization of 12 months may be granted for initial palliative therapy or for treatment of relapsed or refractory ALK-positive ALCL as a single agent.

ANY of the following

Initial palliative therapy for ALK-positive ALCL as a single agent.
Treatment of relapsed or refractory ALK-positive ALCL as a single agent.

D. Histiocytic Neoplasms

Authorization of 12 months may be granted for treatment of any of the following histiocytic neoplasm subtypes as a single agent in members with an ALK gene fusion:

ANY of the following

Symptomatic or relapsed/refractory Erdheim-Chester Disease (ECD).
Symptomatic or relapsed/refractory Rosai-Dorfman Disease.
Langerhans Cell Histiocytosis (LCH).

E. Cutaneous Melanoma

Authorization of 12 months may be granted for subsequent treatment of unresectable or metastatic cutaneous melanoma when all of the following criteria are met:

ALL of the following

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

Reauthorization

Reauthorization (Continuation Therapy):

ALL of the following

Member has previously met initial authorization criteria for the covered indication.
Member has documented clinical benefit (e.g., disease stability, response, or symptom improvement) while on crizotinib.
No unacceptable toxicity that precludes continued therapy; adverse effects are being managed with dose modification or supportive care as appropriate.
There is no documented disease progression that would warrant discontinuation or change of therapy.
Reauthorization requests may be approved for up to 12 months at a time.

Provider Actions and Documentation Requirements

Prior Authorization

Indication-specific prior authorization — NSCLC and other listed tumor types

Authorization of 12 months may be granted when the member meets the specific indication criteria for listed tumor types (see Coverage Criteria sections A–E). Covered NSCLC indications include: recurrent, advanced, or metastatic ALK-positive NSCLC; recurrent, advanced, or metastatic ROS1-positive NSCLC; recurrent, advanced, or metastatic MET exon 14 skipping mutation–positive NSCLC; or NSCLC with high-level MET amplification. Authorization is for single‑agent use and is for a standard 12‑month period.

Authorization period: 12 months
NSCLC criteria: ALK-positive, ROS1-positive, MET exon 14 skipping, or high-level MET amplification
Agent use: single agent

Step Therapy

Melanoma sequencing requirement — prior progression/intolerance with BRAF therapy required

For cutaneous melanoma, prior authorization requires documentation that the tumor is ROS1-positive and that the member has disease progression, intolerance, or a projected risk of progression with BRAF‑targeted therapy prior to authorization for Xalkori as subsequent treatment.

Disease must be ROS1‑positive
Member must have progression, intolerance, or projected risk of progression with BRAF‑targeted therapy (e.g., dabrafenib, encorafenib)
Requested medication must be used as a single agent

Documentation Required

Required diagnostic documentation — molecular biomarker status

Submit molecular diagnostic documentation to initiate prior authorization review: ALK mutation or translocation status, ROS1 mutation status, MET exon 14 skipping mutation status, or high‑level MET amplification status, as applicable to the indication.

Provide ALK mutation/translocation status when applicable
Provide ROS1 mutation status when applicable
Provide MET exon 14 skipping mutation or high‑level MET amplification status when applicable

Denial Risk

Experimental/investigational exclusions — not medically necessary

Indications not listed in the FDA‑approved or compendial uses are considered experimental/investigational and are not medically necessary; requests for Xalkori for those indications are subject to denial.

All other indications outside those listed in the compendia/FDA uses are NMN (experimental/investigational)

Authorization Period and Coding Details

inv-09: Authorization period — 12 months

Authorization period12 months

Applies to initial and reauthorization requestsStandard authorization period referenced for all covered indications (NSCLC, IMT, ALCL, histiocytic neoplasms, cutaneous melanoma)

Documentation timeframeAuthorization length may be granted/reviewed at 12-month intervals per policy

Biomarker Requirements for Coverage

inv-17: ALK

Biomarker requirementALK-positive status required (as detected by an FDA‑approved test) for indicated tumor types

Covered tumor typesNSCLC (metastatic ALK-positive), IMT (ALK-positive), ALCL (ALK-positive relapsed/refractory and pediatric/young adults as per FDA), select histiocytic neoplasms with ALK fusion

Documentation to submitALK mutation or translocation status must be provided to initiate prior authorization review

inv-18: ROS1

Biomarker requirementROS1-positive status required (as detected by an FDA‑approved test) for indicated tumor types

Covered tumor typesNSCLC (metastatic ROS1-positive) and ROS1-positive cutaneous melanoma (subsequent treatment meeting sequencing requirement)

Documentation to submitROS1 mutation status must be provided to initiate prior authorization review

inv-19: MET (exon 14 skipping, high-level amplification)

MET biomarkersMET exon 14 skipping mutation-positive or high-level MET amplification in NSCLC

Covered indicationRecurrent, advanced, or metastatic MET exon 14 skipping mutation-positive NSCLC or NSCLC with high-level MET amplification

Documentation to submitMET exon 14 skipping mutation status or high-level MET amplification status must be provided to initiate prior authorization review

Definitions and Biomarker Terms

inv-15: MET alterations — High-level MET amplification and MET exon 14 skipping mutation: molecular biomarkers used to identify NSCLC patients eligible for crizoti...

DefinitionHigh-level MET amplification and MET exon 14 skipping mutation are molecular biomarkers used to identify NSCLC patients eligible for crizotinib

Required submissionSubmit MET exon 14 skipping mutation status or high-level MET amplification status where applicable

Clinical useThese MET alterations are used to determine eligibility for crizotinib in recurrent, advanced, or metastatic NSCLC

Covered Regimens

Tumor type	Specific eligibility criteria	Required biomarker	Therapy use (single-agent?)	Authorization period
Non-Small Cell Lung Cancer (NSCLC)	Member has recurrent, advanced, or metastatic disease meeting any listed molecular criterion	ALK-positive; ROS1-positive; MET exon 14 skipping mutation-positive; high-level MET amplification	Yes — single-agent crizotinib	12 months
Inflammatory Myofibroblastic Tumor (IMT)	ALK-positive IMT in either advanced/recurrent/metastatic/inoperable uterine sarcoma OR soft tissue sarcoma (non-uterine)	ALK-positive	Yes — single-agent crizotinib	12 months
Anaplastic Large Cell Lymphoma (ALCL)	Initial palliative therapy or treatment of relapsed or refractory disease	ALK-positive	Yes — single-agent crizotinib	12 months
Histiocytic Neoplasms	Symptomatic or relapsed/refractory Erdheim-Chester Disease, Rosai-Dorfman Disease, or Langerhans Cell Histiocytosis with an ALK gene fusion	ALK gene fusion	Yes — single-agent crizotinib	12 months
Cutaneous Melanoma	Unresectable or metastatic disease with prior progression, intolerance, or projected risk of progression on BRAF-targeted therapy	ROS1-positive	Yes — single-agent crizotinib	12 months

Background

Crizotinib (Xalkori) is a targeted tyrosine kinase inhibitor directed against rearrangements or alterations in ALK, ROS1, and certain MET alterations. It is used across multiple tumor types when the corresponding molecular biomarker is present, including non‑small cell lung cancer, anaplastic large cell lymphoma, inflammatory myofibroblastic tumor, cutaneous melanoma (ROS1‑positive), and select histiocytic neoplasms (Erdheim‑Chester Disease, Langerhans Cell Histiocytosis, Rosai‑Dorfman Disease) as listed in compendial references.