Pharmacy Prior Authorization Criteria

Xalkori (crizotinib) - PA, NF

Indications for Prior Authorization

Xalkori (crizotinib)

• For diagnosis of Non-small cell lung cancer (NSCLC)
  Indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)- or ROS1-positive as detected by an FDA-approved test.

• For diagnosis of Anaplastic Large Cell Lymphoma (ALCL)
  Indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.

  Limitations of use: The safety and efficacy of Xalkori have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

• For diagnosis of Inflammatory Myofibroblastic Tumor
  Indicated for the 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.

Criteria

Xalkori

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-small Cell Lung Cancer (NSCLC)

• Diagnosis of metastatic non-small cell lung cancer (NSCLC)
AND
• One of the following:
• Both of the following:
• Patient has an anaplastic lymphoma kinase (ALK)-positive tumor as detected with a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• One of the following:
• Patient has had disease progression on, contraindication or intolerance to, or is not a candidate for one of the following:
• Alecensa (alectinib)
• Alunbrig (brugatinib)
OR
• For continuation of therapy
OR
• Patient has ROS1 rearrangements-positive tumor as detected with a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Xalkori

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Anaplastic Large Cell Lymphoma (ALCL)

• Diagnosis of systemic anaplastic large cell lymphoma (ALCL)
AND
• Disease is one of the following:
• Relapsed
• Refractory
AND
• Patient is 1 year of age or older
AND
• Patient has an anaplastic lymphoma kinase (ALK)-positive tumor as detected with a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Xalkori

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Inflammatory Myofibroblastic Tumor (IMT)

• Diagnosis of inflammatory myofibroblastic tumor (IMT)
AND
• Disease is one of the following:
• Unresectable
• Recurrent
• Refractory
AND
• Patient is 1 year of age or older
AND
• Patient has an anaplastic lymphoma kinase (ALK)-positive tumor as detected with a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Xalkori

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

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

Xalkori

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Non-small Cell Lung Cancer (NSCLC)

• Submission of medical records (e.g., chart notes) confirming diagnosis of metastatic non-small cell lung cancer (NSCLC)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
• Both of the following:
• Patient has an anaplastic lymphoma kinase (ALK)-positive tumor as detected with a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• One of the following:
• Patient has had disease progression on, contraindication or intolerance to, or is not a candidate for one of the following:
• Alecensa (alectinib)
• Alunbrig (brugatinib)
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy
OR
• Patient has ROS1 rearrangements-positive tumor as detected with a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Xalkori

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Anaplastic Large Cell Lymphoma (ALCL)

• Submission of medical records (e.g., chart notes) confirming both of the following:
• Diagnosis of systemic anaplastic large cell lymphoma (ALCL)
AND
• Disease is one of the following:
• Relapsed
• Refractory
AND
• Patient is 1 year of age or older
AND
• Submission of medical records (e.g., chart notes) confirming patient has an anaplastic lymphoma kinase (ALK)-positive tumor as detected with a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Xalkori

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Inflammatory Myofibroblastic Tumor (IMT)

• Submission of medical records (e.g., chart notes) confirming both of the following:
• Diagnosis of inflammatory myofibroblastic tumor (IMT)
AND
• Disease is one of the following:
• Unresectable
• Recurrent
• Refractory
AND
• Patient is 1 year of age or older
AND
• Submission of medical records (e.g., chart notes) confirming the patient has an anaplastic lymphoma kinase (ALK)-positive tumor as detected with a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

P & T Revisions

2024-06-05, 2024-01-04, 2023-11-01, 2023-06-26, 2023-05-24, 2022-09-06, 2022-05-04, 2021-05-26, 2021-04-08, 2021-02-04, 2020-05-01

References

1. Xalkori Prescribing Information. Pfizer Labs. New York, NY. September 2023.
2. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at www.nccn.org. Accessed August 12, 2022.

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Revision History

• 2024-06-05: Annual Review - criteria update
• 2024-01-04: Added new oral pellet formulations, mirroring capsule criteria
• 2023-11-01: Addition of drug specific NF criteria.
• 2023-06-26: Removed specialist requirement.
• 2023-05-24: Annual Review - No criteria changes
• 2022-09-06: Added new indication IMT. Added age criterion to ALCL indication per prescribing information. Updated background and references.
• 2022-05-04: 2022 Annual Review - No criteria changes, updated background information
• 2021-05-26: annual review - no changes. Added EHB formulary.
• 2021-04-08: Updated GPI's
• 2021-02-04: Added embedded step through Alecensa and Alunbrig for NSCLC indication. Added criteria for new indication ALCL. Updated background and references.
• 2020-05-01: Annual review - removed reference to drug name in reauth criteria; updated references.

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