CurrentUnitedHealthcarePolicy N/A

Xalkori (crizotinib) — Pharmacy Coverage Criteria

Defines UnitedHealthcare Pharmacy coverage and authorization criteria for Xalkori (crizotinib) across labeled and select NCCN-recommended/other oncology indications; applies to affected UnitedHealthcare members (special rules for <19 years).

Policy Summary

PayerUnitedHealthcare

PolicyXalkori (crizotinib) — Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionSubmit prior authorization with documentation of diagnosis and required biomarker status; members <19 auto-process without coverage review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

patients <19auto-process for

12 monthsauthorization period

Non-Formularyprogram classification

ROS1required biomarker

Coverage Criteria for Xalkori (crizotinib)

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inv-01: Patients less than 19 years — covered when criteria met; auto-processing without coverage review for patients <19

Covered when the following is met

Patients <19: Patient is less than 19 years of age

Authorization will be issued for 12 months; prescriptions for members under 19 automatically process without a coverage review.

inv-02: IMT (Initial and Reauthorization) — initial authorization

Initial authorization

IMT with ALK translocation: Diagnosis of inflammatory myofibroblastic tumor (IMT) with ALK translocation

Authorization will be issued for 12 months.

Reauthorization: Patient does not show evidence of progressive disease while on Xalkori therapy

Authorization will be issued for 12 months.

inv-03: NSCLC — initial authorization

Initial authorization for NSCLC

NSCLC diagnosis: Diagnosis of non-small cell lung cancer (NSCLC)

Disease extent: Disease is metastatic, recurrent, or advanced

Biomarker/sequence criteria: One of: tumor is ROS1-positive; tumor is positive for MET amplification; tumor is positive for MET exon 14 skipping mutation; OR tumor is ALK-positive with provider attestation that the patient has a contraindication, history of intolerance, or is not an appropriate candidate (document reason) to Alecensa (alectinib), Alunbrig (brigatinib), and Lorbrena (lorlatinib)

Provider must attest and document reasons for not using preferred ALK agents. Authorization will be issued for 12 months.

inv-04: NSCLC — reauthorization criteria

Reauthorization

Current therapy or response: Either patient is currently on Xalkori therapy OR patient does not show evidence of progressive disease while on Xalkori therapy

Patients established via manufacturer samples or Pfizer Oncology Together assistance must meet initial authorization criteria as if new to therapy; approvals issued for 12 months.

inv-05: NSCLC brain metastases — initial authorization

Initial authorization

Brain metastases from NSCLC: Diagnosis of metastatic brain cancer from NSCLC

Patient must not show evidence of progressive disease while on Xalkori for authorization; authorization will be issued for 12 months.

inv-06: Anaplastic large cell lymphoma (ALCL) — initial authorization

Initial authorization

ALCL: Diagnosis of anaplastic large cell lymphoma AND tumor is ALK-positive AND disease is relapsed or refractory

Authorization will be issued for 12 months; reauthorization requires no evidence of progressive disease.

inv-07: Histiocytic neoplasms with ALK rearrangement — initial authorization

Initial authorization

Histiocytic neoplasms with ALK rearrangement: Diagnosis of Langerhans Cell Histiocytosis, Erdheim-Chester Disease, or Rosai-Dorfman Disease AND disease is positive for ALK rearrangement

Authorization will be issued for 12 months; reauthorization requires no evidence of progressive disease.

inv-08: ROS1 fusion-positive cutaneous melanoma — initial authorization

Initial authorization

ROS1 fusion-positive cutaneous melanoma: Diagnosis of metastatic or unresectable cutaneous melanoma AND disease is ROS1 gene fusion-positive AND used as second-line or subsequent therapy for disease progression, intolerance, and/or projected risk of progression with BRAF-targeted therapy

Authorization will be issued for 12 months; reauthorization requires no evidence of progressive disease.

inv-09: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Authorization for Xalkori: (1) Diagnosis of metastatic or unresectable cutaneous melanoma AND (2) Disease is ROS1 gene fusion-positive AND (3) Used as second-line or subsequent therapy for disease progression, intolerance, and/or projected risk of progression with BRAF-targeted therapy

Authorization will be issued for 12 months; see plan specifics for exclusion status.

inv-10: Continuation Therapy / Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization for Xalkori: Patient does not show evidence of progressive disease while on Xalkori therapy

Authorization will be issued for 12 months.

Some states have mandates that require coverage for off‑label uses or that require reliance on specific compendia. Where a state mandate applies, it supersedes the language in this policy. These state‑specific requirements are not enumerated in this document; providers should follow applicable state mandates and benefit plan terms when they conflict with the criteria below.

Xalkori (crizotinib) is typically excluded from coverage in some benefit plans and may be subject to plan‑specific tried/failed or exclusion rules. Providers and billing staff must refer to the member's specific plan details to determine whether Xalkori is excluded and whether any step‑therapy or tried/failed requirements apply before submitting an authorization request.

Initial Therapy — Indication-Specific Criteria

inv-26: Initial therapy — indications; initial authorization criteria by indication

Initial authorization criteria by indication

Pediatrics <19: Patient is less than 19 years of age

Authorization for 12 months and prescriptions auto-process without coverage review.

IMT: Diagnosis of inflammatory myofibroblastic tumor (IMT) with ALK translocation

Authorization for 12 months.

NSCLC general: Diagnosis of metastatic, recurrent, or advanced NSCLC

Additional biomarker and sequencing requirements apply (see coverage criteria).

Brain metastases: Diagnosis of metastatic brain cancer from NSCLC

Authorization for 12 months.

ALCL: Diagnosis of anaplastic large cell lymphoma AND tumor is ALK-positive AND disease is relapsed or refractory

Authorization for 12 months.

Histiocytic neoplasms: Diagnosis of LCH, ECD, or Rosai-Dorfman Disease AND disease is ALK rearrangement-positive

Authorization for 12 months.

Cutaneous melanoma: Diagnosis of metastatic or unresectable cutaneous melanoma AND disease is ROS1 gene fusion-positive AND used as second-line or subsequent therapy for progression/intolerance or projected risk with BRAF-targeted therapy

Authorization for 12 months.

inv-27: Initial Authorization — initial coverage rules for Xalkori

Initial coverage rules for Xalkori

Initial Authorization: Diagnosis of metastatic or unresectable cutaneous melanoma AND ROS1 gene fusion-positive AND used as second-line or subsequent therapy for disease progression, intolerance, and/or projected risk of progression with BRAF-targeted therapy

Authorization issued for 12 months

Continuation / Reauthorization Criteria

inv-28: Continuation therapy — reauthorization/continuation criteria

Reauthorization/continuation criteria

No progressive disease: Patient does not show evidence of progressive disease while on Xalkori therapy

Authorization will be issued for 12 months upon meeting this condition.

inv-29: Reauthorization — reauthorization for continued Xalkori therapy

Reauthorization for continued Xalkori therapy

Reauthorization: No evidence of progressive disease while on Xalkori

Authorization issued for 12 months

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for Xalkori except for patients under 19 years of age. Typical authorization periods are 12 months for initial and reauthorization requests. Coverage may vary by plan; some UnitedHealthcare plans typically exclude Xalkori and may require tried/failed criteria — refer to the member's plan for exclusions and step therapy rules.

Prior authorization required except patients < 19 years (see pediatric exception)
Standard authorization duration: 12 months (initial and reauthorization)
Plan-specific exclusions and tried/failed rules may apply — check member plan

Documentation Required

Required Clinical Documentation

Document the diagnosis and relevant biomarker status for all requests. Required clinical documentation depends on the indication but must include: confirmation of diagnosis (e.g., NSCLC, metastatic brain cancer from NSCLC, anaplastic large cell lymphoma, Langerhans cell histiocytosis, Erdheim‑Chester disease, Rosai‑Dorfman disease, metastatic or unresectable cutaneous melanoma), and tumor biomarker status (ROS1 gene fusion positivity, MET amplification, MET exon 14 skipping mutation, or ALK rearrangement/ALK‑positive). For ALK‑positive NSCLC requests, document prior ALK‑directed therapy history or an attestation that the patient has contraindication/intolerance or is not an appropriate candidate to Alecensa (alectinib), Alunbrig (brigatinib), and Lorbrena (lorlatinib).

Diagnosis documentation (specific cancer type and disease stage: metastatic, recurrent, advanced, relapsed/refractory, or unresectable as applicable)
Tumor biomarker documentation: ROS1+, MET amplification, MET exon 14 skipping, or ALK+
For ALK+ NSCLC: prior use of alectinib, brigatinib, and lorlatinib OR documented contraindication/intolerance or clinical inappropriateness to all three (must document reason)

Documentation Required

Establishment via Free Samples or Assistance

For initial authorization, patients who were only established on Xalkori via manufacturer free samples, Pfizer Oncology Together assistance, or a free pharmacy trial are treated as new to therapy and must meet initial authorization criteria.

Receipt of manufacturer supplied sample, Pfizer Oncology Together assistance, or a 30‑day free pharmacy trial does NOT qualify as established use
Such patients must meet full initial authorization criteria as if new to therapy

Denial Risk

Missing Indication or Biomarker — Denial Risk

Requests missing the required indication or biomarker documentation (for example, lack of documentation that the disease is metastatic/unresectable ROS1‑positive cutaneous melanoma used as second‑line or later therapy) risk denial.

Missing documentation of ROS1 positivity for ROS1‑directed indications
Missing documentation that metastatic/unresectable cutaneous melanoma is being treated and that Xalkori is second‑line or subsequent therapy

Documentation Required

Progression on Therapy and Reauthorization

At reauthorization, include documentation that the patient does not have evidence of progressive disease while on Xalkori therapy. UnitedHealthcare may also use prior claim/medication history, diagnosis codes, and claim logic to approve initial or reauthorizations per program rules. Supply limits may apply.

Reauthorization requires evidence the patient is not progressing on therapy
UnitedHealthcare may approve based on claims/medication history and diagnosis codes in some programs
Supply limits may be enforced

Step Therapy

Step / Therapeutic Sequencing for ALK+ NSCLC

Therapeutic sequencing requirements apply for ALK‑positive NSCLC: approval requires prior use of recommended ALK inhibitors or a documented contraindication, intolerance, or inappropriateness to those agents (provider attestation required). Check the member's plan for any step therapy/ tried‑and‑failed requirements or coverage exclusions.

For ALK+ NSCLC, document prior therapy with alectinib, brigatinib, and lorlatinib OR attest to contraindication/intolerance/inappropriateness for each (document reason)
Refer to plan specifics for step therapy rules, tried/failed criteria, or exclusion status

Step Therapy and Therapeutic Sequencing

Step	Requirement
1
For ALK-positive NSCLC: tumor must be ALK-positive and provider must attest that the patient has a contraindication, history of intolerance, or is not an appropriate candidate (document reason) to Alecensa (alectinib), Alunbrig (brigatinib), and Lorbrena (lorlatinib). Authorization issued for 12 months.

Note	Action
Plan-specific exclusions/tried-failed rules
Xalkori is typically excluded from some plans and may be subject to plan-level tried/failed or exclusion rules; refer to the member's specific plan for exclusion status and any step therapy requirements.

Quantity Limits

Xalkori (crizotinib) — quantity limits may be in place

Quantity limitsSupply limits may be in place for Xalkori (crizotinib)

Program variationSupply/quantity limits and automated approval processes vary by program and therapeutic class

Approval basisUnitedHealthcare may approve initial and re-authorization based on prior claim/medication history and diagnosis codes

Site of Care and Processing Notes

Billing Rule

Authorizations may use automated claim/medication history and diagnosis codes

Authorizations and approvals may be processed using automated claims/medication history, diagnosis codes (ICD-10), and claim logic depending on the program; no explicit site-of-care restriction is specified.

Definitions and Key Terms

IMT (Inflammatory Myofibroblastic Tumor) with ALK translocation

DefinitionInflammatory myofibroblastic tumor (IMT) that harbors an ALK translocation

Requirement for approvalPresence of ALK translocation is required for initial authorization of Xalkori for IMT

Supporting guidanceNCCN recommends Xalkori as single-agent therapy for IMT with ALK translocation

biomarker requirement — ROS1 gene fusion-positive

Required biomarkerTumor must be ROS1 gene fusion-positive

Indication contextApplies to metastatic or unresectable cutaneous melanoma when used as second-line or subsequent therapy vs BRAF-targeted therapy

Authorization periodAuthorization issued for 12 months when criteria are met

Background

Crizotinib (Xalkori) is an oral small‑molecule kinase inhibitor targeting ALK and ROS1 rearrangements and other relevant tyrosine kinases. It is indicated for patients with metastatic non‑small cell lung cancer (NSCLC) whose tumors are ALK‑positive or ROS1‑positive, and for certain ALK‑positive pediatric and adult malignancies (for example, inflammatory myofibroblastic tumor and relapsed/refractory anaplastic large cell lymphoma). NCCN and other compendia also recognize use in select molecular contexts and tumor types (for example, ROS1‑positive brain metastases, histiocytic neoplasms with ALK rearrangements, and ROS1 fusion‑positive cutaneous melanoma) as described in the coverage criteria.

Revision History

2025-05-01policy_effectiveLatest

Policy effective date updated to 2025-05-01; program listed as Non‑Formulary with P&T approval history through 2/2025.

Policy Summary

PayerUnitedHealthcare

PolicyXalkori (crizotinib) — Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionSubmit prior authorization with documentation of diagnosis and required biomarker status; members <19 auto-process without coverage review.

SourceLink

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