CurrentUnitedHealthcarePolicy 2026 P 1115-15

Xalkori (crizotinib) prior authorization / coverage criteria

UnitedHealthcare prior authorization/notification policy for Xalkori (crizotinib) defining initial and reauthorization clinical criteria for multiple tumor types (NSCLC, IMT, ALCL, histiocytic neoplasms, cutaneous melanoma, uterine neoplasms, metastatic brain cancer, pediatric use) and applicable program rules. Effective for requests processed under the plan; members under 19 auto-process without review.

Policy Summary

PayerUnitedHealthcare

PolicyXalkori (crizotinib) prior authorization / coverage criteria

Policy CodePolicy 2026 P 1115-15

Change TypeAnnual review / revised

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionPrior authorization/notification required for Xalkori; authorization typically issued for 12 months when specified clinical criteria are met.

POLICY UPDATE CHANGES

Annual review 2/2026: Updated background and coverage criteria for uterine neoplasms per NCCN; updated reference.

2/2024: Updated background and coverage criteria for cutaneous melanoma per NCCN.

2/2022: Updated background and references; added clinical criteria for histiocytic neoplasms positive for ALK rearrangement.

2/2015: Added coverage for MET-amplification positive NSCLC.

9Covered indications listed

12mStandard authorization duration

Pediatric auto-approvalMembers <19 processing

Coverage Summary

Policy number 2026 P 1115-15 — Subject: Xalkori (crizotinib) prior authorization / coverage criteria. Coverage stance: covered_with_criteria for specified tumor types and molecular statuses. Scope: UnitedHealthcare prior authorization/notification policy defining initial and reauthorization clinical criteria for multiple tumor types (NSCLC, IMT, ALCL, histiocytic neoplasms, cutaneous melanoma, uterine neoplasms, metastatic brain cancer, pediatric use) and applicable program rules; members <19 years auto-process without coverage review. Standard authorization duration: 12 months for initial approvals and reauthorizations per criteria. Effective date: 2026-05-01; Last review: 2026-02.

Key summary

Coverage stancecovered_with_criteria

Authorization duration12 months (standard)

Covered indications count9

Pediatric processingMembers <19 auto-process without coverage review (pediatric auto-approval)

Effective date2026-05-01

Last review2026-02

Policy number2026 P 1115-15

Initial Authorization Criteria (by indication)

Non-Small Cell Lung Cancer (NSCLC) Initial Authorization

Initial Authorization - Authorization will be issued for 12 months when BOTH criteria are met:

ALL of the following

Diagnosis: non-small cell lung cancer (NSCLC)
Disease status
- Metastatic
- Recurrent
- Advanced
Molecular status (ONE of)
- Tumor is anaplastic lymphoma kinase (ALK)-positive
- Tumor is ROS1-positive
- Tumor is positive for mesenchymal-epithelial transition (MET) amplification
- Tumor is positive for MET exon 14 skipping mutation

Soft Tissue Sarcoma (Inflammatory Myofibroblastic Tumor - IMT)

Initial Authorization - Authorization will be issued for 12 months when BOTH criteria are met:

ALL of the following

Diagnosis of Soft Tissue Sarcoma
Tumor is an inflammatory myofibroblastic tumor (IMT) with ALK translocation

Metastatic Brain Cancer from NSCLC Initial Authorization

Initial Authorization - Authorization will be issued for 12 months when BOTH criteria are met:

ALL of the following

Diagnosis of metastatic brain cancer from NSCLC
ANY of the following
- Tumor is anaplastic lymphoma kinase (ALK)-positive
- Tumor is ROS1-positive

Anaplastic Large Cell Lymphoma (ALCL) Initial Authorization

Authorization will be issued for 12 months when ALL criteria are met:

ALL of the following

Diagnosis of anaplastic large cell lymphoma
Tumor is anaplastic lymphoma kinase (ALK)-positive
Disease is relapsed or refractory

Histiocytic Neoplasms Initial Authorization

Authorization will be issued for 12 months when ALL criteria are met:

ALL of the following

Diagnosis (ONE of)
- Langerhans Cell Histiocytosis
- Erdheim-Chester Disease
- Rosai-Dorfman Disease
Disease is positive for ALK rearrangement

Metastatic or Unresectable Cutaneous Melanoma Initial Authorization

Authorization will be issued for 12 months when ALL criteria are met:

ALL of the following

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

Uterine Sarcoma Initial Authorization

Authorization will be issued for 12 months when ALL criteria are met:

ALL of the following

Diagnosis of uterine sarcoma
Disease status (ONE of)
- Metastatic
- Recurrent
- Advanced
- Inoperable

Patients less than 19 years of age

Authorization will be issued for 12 months when the following is met:

ALL of the following

Patient is less than 19 years of age

NCCN Recommended Regimens

Authorization will be issued for 12 months when the drug is recognized by the NCCN Drugs and Biologics Compendium with Category 1, 2A, or 2B:

The drug has NCCN Drugs and Biologics Compendium recognition with Category of Evidence and Consensus of 1, 2A, or 2B

Reauthorization / Continuation Criteria

Soft Tissue Sarcoma (IMT) Reauthorization

Authorization will be issued for 12 months when the following is met:

ALL of the following

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

NSCLC Reauthorization

Authorization will be issued for 12 months when the following is met:

ALL of the following

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

Metastatic Brain Cancer Reauthorization

Authorization will be issued for 12 months when the following is met:

ALL of the following

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

ALCL Reauthorization

Authorization will be issued for 12 months when the following is met:

ALL of the following

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

Histiocytic Neoplasms Reauthorization

Authorization will be issued for 12 months when the following is met:

ALL of the following

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

Cutaneous Melanoma Reauthorization

Authorization will be issued for 12 months when the following is met:

ALL of the following

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

Uterine Sarcoma Reauthorization

Authorization will be issued for 12 months when the following is met:

ALL of the following

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

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Xalkori (crizotinib). Authorization is typically issued for 12 months when the specified clinical criteria are met. Note: prescriptions for members under 19 years of age will automatically process without a coverage review.

Documentation Required

Clinical documentation required

Providers must document the patient’s diagnosis and molecular status (for example: ALK-positive, ROS1-positive, MET amplification, MET exon 14 skipping mutation, ALK rearrangement, ROS1 gene fusion) and disease status (metastatic, recurrent, advanced, or inoperable as applicable) to meet authorization criteria.

Billing Rule

Supply limits and program automation

Supply limits may be in place. UnitedHealthcare may approve initial authorizations and reauthorizations based solely on prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated approval and re‑approval processes varies by program.

Clinical Evidence & References

Xalkori (crizotinib) is an FDA-indicated kinase inhibitor for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive, and is approved for certain ALK-positive malignancies including relapsed/refractory systemic anaplastic large cell lymphoma (ALCL) and unresectable/recurrent/refractory inflammatory myofibroblastic tumor (IMT) in adults and pediatric patients. The policy notes additional NCCN-supported uses including MET-amplified NSCLC, MET exon 14 skipping mutation NSCLC, ALK- or ROS1-positive brain metastases from NSCLC, histiocytic neoplasms with ALK rearrangement, ROS1 fusion–positive metastatic/unresectable cutaneous melanoma, and uterine neoplasms. Primary reference: Xalkori package insert (September 2023); Guideline reference: NCCN Drugs and Biologics Compendium (accessed 2026-01-09).

Evidence

P&T Approval Dates9/2011–2/2026 (periodic reviews)

Primary referenceXalkori package insert (September 2023)

Guideline sourceNCCN Drugs and Biologics Compendium (accessed 2026-01-09)

Revision History

2026-02revised (non-material)Latest

Annual review 2/2026: Updated background and coverage criteria for uterine neoplasms per NCCN; updated reference.

2025-02revised (non-material)

Annual review 2/2025: Annual review with no change to clinical criteria; updated references.

2024-02revised (non-material)

2/2024: Annual review. Updated background and coverage criteria for cutaneous melanoma per NCCN; updated references.

2023-02revised (non-material)

2/2023: Annual review with no change to clinical criteria; updated background and references; added state mandate footnote.

2022-02revised (material)

2/2022: Annual review. Updated background and references; added clinical criteria for histiocytic neoplasms positive for ALK rearrangement.

2021-02revised (non-material)

2/2021: Annual review with no changes to clinical coverage criteria; updated references.

2020-02revised (non-material)

2/2020: Annual review. Added general NCCN recommendations for use criteria; updated references.

2019-01revised (non-material)

1/2019: Updated criteria for anaplastic large cell lymphoma and NSCLC.

2018-11revised (non-material)

11/2018: Annual review. Updated background and criteria to align with NCCN recommendations for metastatic brain cancer and ALK-positive anaplastic large cell lymphoma; updated references.

2017-11revised (non-material)

11/2017: Annual review with no changes to clinical coverage criteria; updated references.

2016-12revised (non-material)

12/2016: Annual review. Updated ROS1-positive clinical criteria to reflect on-label indication; updated background and references.

2016-02revised (non-material)

2/2016: Annual review. Updated clinical criteria for metastatic NSCLC; updated background and references.

2015-02revised (material)

2/2015: Annual review. Added coverage for MET-amplification positive NSCLC; updated background and references.

2014-02revised (non-material)

2/2014: Change control. Updated references.

2013-07revised (non-material)

7/2013: P&T update.

2012-08revised (non-material)

8/2012: P&T update.

2011-09initial approval

9/2011: P&T initial approval; program inception.

OpenPayer

Xalkori (crizotinib) prior authorization / coverage criteria

Coverage Summary

Initial Authorization Criteria (by indication)

Reauthorization / Continuation Criteria

Provider Actions & Documentation Requirements

Applicable Codes

Clinical Evidence & References

Definitions

Revision History