CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xalkori (crizotinib) — Coverage Criteria

Defines accepted indications, coverage criteria, exclusions, and authorization requirements for Xalkori (crizotinib) for members of Neighborhood Health Plan of Rhode Island processed by Evolent. Applies to providers requesting authorization for Xalkori for oncology indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXalkori (crizotinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTechnical/annual review — no material changes

Effective DateNovember 29, 2024

Next Review DateN/A

Key ActionSubmit prior authorization to Evolent/UM with documentation confirming ALK or ROS1 rearrangement and prior therapy/progression evidence where required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

21+committee review years

120monthly capsule limit

1 yrcontinuation lookback

≥1ALCL prior therapy req

Coverage Criteria for Xalkori (crizotinib)

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Indication-specific coverage criteria

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

Continuation requests exemption: The requested medication was used within the last year AND the member has not experienced disease progression and/or intolerance to the requested medication AND additional medication(s) are not being added to the continuation request.

Section II.A

Anaplastic Large Cell Lymphoma (ALCL): Member is ≤21 years old with relapsed or refractory ALCL AND tumor is ALK positive (Anaplastic Lymphoma Kinase confirmed by testing prior to initiation of treatment) AND member has experienced disease progression on at least one prior therapy.

Section II.B

Non-Small Cell Lung Cancer (NSCLC): Member has locally advanced, recurrent, or metastatic NSCLC AND tumor is ROS1 or ALK rearrangement positive (confirmed by testing prior to initiation of treatment); Xalkori may be used as single-agent first-line or subsequent therapy.

Section II.C

Inflammatory Myofibroblastic Tumor (IMT): Member aged ≥1 year with IMT that is ALK fusion positive (confirmed prior to treatment); Xalkori may be used as a single agent.

Section II.D

Coverage will be denied when any of the exclusion criteria apply. Specifically, requests for Xalkori (crizotinib) will be excluded if the drug is being used concurrently with chemotherapy or if there is an absence of documented ROS1 or ALK testing and the results supporting the requested indication (see required documentation expectations).

Dosing that exceeds the stated single-dose limits is not covered: 250 mg per single dose for NSCLC and IMT, and 500 mg per single dose for ALCL. Monthly quantity caps will also trigger denial when exceeded: coverage does not apply beyond 120 capsules per month for the 250 mg or 200 mg capsule formulations, or beyond the pellet limits of 120 (20 mg), 120 (50 mg), or 180 (150 mg) oral pellets per month.

Off-label or investigational uses lacking sufficient supporting evidence are excluded. Evidence is considered insufficient when key elements of CMS-acceptable evidence are missing or weak, for example inadequate representation of the patient/cancer population, inadequate representation of the regimen used, lack of clinically meaningful outcomes, inappropriate experimental design, reliance on uncontrolled case reports, or reliance on abstracts without full peer-reviewed publications.

Xalkori (crizotinib) use for investigational or off‑label indications will be considered not covered when the indication is not supported by sufficient evidence recognized by CMS compendia or acceptable peer‑reviewed literature. The policy defines insufficient evidence to include: inadequate representation of the relevant patient or tumor characteristics in published studies; inadequate representation of the specific therapy regimen in the literature; absence of clinically meaningful outcomes (for example, recommended ASCO thresholds such as hazard ratios or minimum survival benefits); and study design limitations that prevent reliable interpretation.

The policy also states that uncontrolled case reports are generally inadequate to establish accepted uses and that abstracts or meeting reports without full peer‑reviewed articles do not provide sufficient supporting clinical evidence for coverage of off‑label indications.

Single-Dose and Quantity Limits

inv-04: Single dose limit — 250 mg (NSCLC and IMT); 500 mg (ALCL).

Single-dose limit (NSCLC and IMT)250 mg per single dose

Single-dose limit (ALCL)500 mg per single dose

ContextDosing above these single-dose limits is an exclusion to coverage

inv-05: Monthly capsule/pellet limits — 120 (250 mg) or 120 (200 mg) capsules; or 120 (20 mg), 120 (50 mg), or 180 (150 mg) oral pellets per month.

250 mg capsulesMaximum 120 capsules per month

200 mg capsulesMaximum 120 capsules per month

20 mg oral pelletsMaximum 120 pellets per month

50 mg oral pelletsMaximum 120 pellets per month

150 mg oral pelletsMaximum 180 pellets per month

inv-16: Xalkori (crizotinib) quantity summary — monthly capsule/pellet equivalencies and limits.

Capsule equivalency (250 mg)Up to 120 capsules per month

Capsule equivalency (200 mg)Up to 120 capsules per month

Pellet equivalency (20 mg)Up to 120 pellets per month

Pellet equivalency (50 mg)Up to 120 pellets per month

Pellet equivalency (150 mg)Up to 180 pellets per month

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required through Evolent/UM prior to initiation. Continuation requests are permitted when the medication was used within the last year, there is no disease progression or intolerance, and no additional medications are being added to the request.

Prior authorization required through Evolent/UM for all initial and continuation requests unless continuation exemption criteria are met.
Continuation request rules: medication used within last 12 months; no disease progression or intolerance; no additional meds added.

Step Therapy

Step / Sequence Requirements

Xalkori (crizotinib) is indicated for ALCL only for relapsed/refractory disease in patients 21 years old or younger and requires documented progression on at least one prior therapy. For NSCLC and IMT, therapy is limited to tumors confirmed positive for ALK or ROS1 rearrangement/fusion prior to initiation. Age-specific notes: ALCL — ≤21 years; IMT — ≥1 year; NSCLC — adult and pediatric as clinically appropriate.

ALCL: relapsed/refractory disease AND progression on ≥1 prior therapy; member ≤21 years.
NSCLC: locally advanced, recurrent, or metastatic disease with ALK or ROS1 rearrangement/fusion — may be first-line or subsequent therapy.
IMT: ALK fusion positive inflammatory myofibroblastic tumor for members aged ≥1 year.

Documentation Required

Required Documentation

Documentation must include confirmation of ALK and/or ROS1 rearrangement/fusion testing (as applicable) performed and results available prior to initiation of Xalkori (crizotinib). For ALCL, documentation of age and prior therapy with documented progression is required. For continuation requests, include evidence the drug was used within the last year and there is no progression or intolerance.

Documented ALK and/or ROS1 testing and results prior to treatment initiation.
For ALCL: documentation of patient age (≤21 years) and prior therapy with documented progression on ≥1 prior regimen.
For continuation: evidence of prior use within 12 months, no disease progression, and no added medications.

Denial Risk

Triggers for Denial

Requests will be denied when Xalkori (crizotinib) is used concurrently with chemotherapy, when there is no documented ROS1/ALK testing and results for applicable indications, or when dosing or monthly quantity limits are exceeded. Investigational or off‑label uses lacking sufficient evidence (not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature) are excluded.

Concurrent use with chemotherapy — denial trigger.
Absence of documented ALK/ROS1 testing and results — denial trigger.
Single dose limits: >250 mg (NSCLC, IMT) or >500 mg (ALCL) — denial trigger.
Monthly quantity limits exceeded: 120 (250 mg) or 120 (200 mg) capsules/month; 120 (20 mg), 120 (50 mg), or 180 (150 mg) oral pellets/month — denial trigger.
Investigational/off‑label use without sufficient supporting evidence or compendia — denial trigger.

Indication	Requirement before coverage
Anaplastic Large Cell Lymphoma (ALCL) — members ≤21 years	Member has relapsed/refractory ALCL that is ALK positive (confirmed prior to treatment) AND member has experienced disease progression on at least one prior therapy

Key Definitions

inv-11: ALK/ROS1 positive — definition and testing requirement (molecular confirmation prior to initiation).

DefinitionPositive for ALK or ROS1: molecular testing confirming ALK (Anaplastic Lymphoma Kinase) rearrangement or ROS1 rearrangement/fusion prior to initiation of treatment

RequirementTest results must be documented prior to initiation of Xalkori

Indication examplesALK positivity required for ALCL and IMT; ROS1 or ALK rearrangement required for NSCLC

inv-12: Continuation request — definition (used within last year without progression/intolerance).

DefinitionContinuation request: a request to continue a medication that was used within the last year

Continuation criteriaMember has not experienced disease progression and/or no intolerance to the requested medication

Additional medication ruleNo additional medication(s) are being added to the continuation request

OpenPayer

Xalkori (crizotinib) — Coverage Criteria

Coverage Criteria for Xalkori (crizotinib)

Single-Dose and Quantity Limits

Provider Requirements and Authorization

Initial Therapy — Indication-Specific Rules

Continuation Therapy and Renewal Rules

Step / Sequence Requirements

Key Definitions

Background

Site of Care and Administration