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Prior Authorization Protocol
XALKORIR (crizotinib)

NATL

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
  2. Health Net Approved Indications and Usage Guidelines:
    • Patient has a diagnosis of locally advanced or metastatic NSCLC that is ALK-positive

    OR

    • Single-agent therapy for recurrence or metastasis in patients with ROS1 (receptor tyrosine kinase of the insulin receptor family)- or ALK-positive tumors of nonsquamous cell histology (NSCLC)

    OR

    • Second-line therapy for progressive asymptomatic disease, symptomatic isolated lesions, or multiple symptomatic brain lesions (NSCLC)

    OR

    • Single agent therapy for the treatment of Inflammatory Myofibroblastic Tumor (IMT) [a type of Soft Tissue Sarcoma] with ALK translocation
    OR
    • Activity against MET (mesenchymal-epithelial transition) amplifications in lung cancer
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Advanced disease is defined as recurrence or metastatic (spread of cancer to other sites).
    • National Comprehensive Cancer Network (NCCN) Practice Guidelines for Soft Tissue Sarcoma, Xalkori is recommended as single agent therapy for the treatment of IMT with ALK Translocation.
    • NCCN Practice Guidelines for NSCLC, Xalkori has a 2A recommendation as single agent therapy for recurrence or metastasis in patients with ROS1- or ALK-positive tumors of nonsquamous cell histology as first-line therapy or second-line therapy for progressive asymptomatic disease, symptomatic isolated lesions, or multiple symptomatic brain lesions. NCCN also recommends Xalkori (2A) for activity against MET amplifications in lung cancer. MET is thought to give rise to a metastatic lesion with cellular characteristics of the original tumor.
    • National Comprehensive Cancer Network (NCCN) Practice Guidelines for NSCLC has the following recommendations:
      • Xalkori as first-line therapy for ALK-positive patients
      • Tarceva or Gilotrif as first-line therapy for EGFR-positive patients
      • Systemic chemotherapy regimens for first-line therapy for advanced NSCLC where ALK/EGFR mutation is negative or unknown
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    Cisplatin
    Carboplatin
    Paclitaxel
    Docetaxel
    Vinorelbine
    GemzarR (gemcitabine)
    Etoposide
    Irinotecan
    Vinblastine
    AvastinR (bevacizumab)
    AlimtaR (pemetrexed)
    Various doses

    Number of cycles vary

    Tarceva (erlotinib)

    EGFR positive disease: 150 mg PO QD

    150 mg

    Gilotrif (afatinib)*

    EGFR positive disease: 40 mg PO QD40 mg

    Zykadia (ceritinib)*

    ALK positive NSCLC: 750 mg PO QD

    750 mg

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Xalkori

    250 mg PO BID
    May require reduction to 200 mg BID or 250 mg QD

    Length of benefit or until disease progression

  7. Product Availability:
    Capsules: 250 mg and 200 mg
  8. References:
    1. Xalkori [Prescribing Information]. New York, NY: Pfizer; March 2015.
    2. Clinical Pharmacology Web site. Available at: http://www.clinicalpharmacology-ip.com/default.aspx. Accessed June 17, 2015.
    3. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 17, 2015.
    4. National Comprehensive Cancer Network. Soft Tissue Sarcoma. Version 1.2015 Available at: http://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf. Accessed June 17, 2015.
    5. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer Version 6.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed June 17, 2015.
    6. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 17, 2015.
    7. Micromedex Healthcare Series. Micromedex Web site. Available at http://www.thomsonhc.com. Accessed June 17, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.