XALKORI (crizotinib)

XALKORI (crizotinib)

Self-Administration – oral

Diagnosis considered for coverage:

• 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.

• 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.

• 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.

Coverage Criteria:

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

• Dose does not exceed 500 mg/day; AND 

• Prescribed by or in consultation with an oncologist; AND

• Patient has 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 prior therapy; OR

  • Patient has MET amplification- or 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)

For diagnosis of anaplastic Large Cell Lymphoma (ALCL):

• Dose does not exceed 560 mg/m2/day; AND

• Patient is 1 year of age or older; AND

• Prescribed by or in consultation with an oncologist or hematologist; AND

• Disease is one of the following:

  • Relapsed

  • Refractory; 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)

For diagnosis of inflammatory Myofibroblastic Tumor:

• Dose does not exceed:

  • Adults: 500 mg/day

  • Pediatrics: 560 mg/m2/day; AND

• Patient is 1 year of age or older; AND

• Prescribed by or in consultation with an oncologist; AND

• Patient has a diagnosis of inflammatory myofibroblastic tumor (IMT); AND

• Disease is one of the following:

  • Unresectable 

  • Recurrent

  • Refractory; 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)

Reauthorization Criteria:

For all indications:

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

Coverage Duration: 

• Initial: 1 year

• Reauthorization: 1 year

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

• The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

Additional Information: 

• Dosing

  • Metastatic NSCLC: The recommended dosage is 250 mg orally twice daily.

  • Systemic ALCL: The recommended dosage is 280 mg/m2 orally twice daily based on body surface area.

  • Unresectable IMT:

    • Adult: The recommended dosage is 250 mg orally twice daily.

    • Pediatric: The recommended dosage is 280 mg/m2 orally twice daily based on body surface area.

• Drug Interactions

  • Strong CYP3A Inhibitors: Avoid concomitant use.

  • Strong CYP3A Inducers: Avoid concomitant use.

  • CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious adverse reactions.

Policy Updates:

• 05/16/2023 – New policy approved by P&T.

References:

• Xalkori Prescribing Information. Pfizer Labs. New York, NY. July 2022.

• The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at www.nccn.org. Accessed August 12, 2022.

• National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell LungCancer Version 2.2023, 02/17/23; National Comprehensive Cancer Network. Available from: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.