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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 member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • 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.
    • Treatment of patients with metastatic NSCLC whose tumors are ROS1 (receptor tyrosine kinase of the insulin receptor family)-positive
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of recurrent or metastatic NSCLC that is ALK-positive or ROS1-positive

    OR

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

    OR

    • Activity against MET (mesenchymal-epithelial transition) amplifications in lung cancer

    OR

    • Single agent therapy for the treatment of Inflammatory Myofibroblastic Tumor (IMT) [a type of Soft Tissue Sarcoma] with ALK translocation
  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).
    • In the pivotal trial, the ROS1 (receptor tyrosine kinase of the insulin receptor family) status of NSCLC tissue samples was determined by laboratory-developed break-apart fluorescent in situ hybridization (FISH) (96%) or reverse transcription polymerase chain reaction (RT-PCR) (4%) clinical trial assays. For assessment by FISH, ROS1 positivity required that >=15% of a minimum of 50 evaluated nuclei contained a ROS1 gene rearrangement.
    • According to National Comprehensive Cancer Network (NCCN) Practice Guidelines, treatment of NSCLC is further categorized by histological findings with gene alteration and rearrangement: 1) ROS1-positive  Xalkori, 2) EGFR mutation and ALK negative - platinum-based chemotherapy (e.g. cisplatin+Alimta), 3) EGFR mutation positive  Iressa, Gilotrif, Tarceva, Tagrisso, and 4) ALK positive - Xalkori, Zykadia, Alecensa.
    • According to NCCN Practice Guidelines for Soft Tissue Sarcoma, Xalkori is recommended as single agent therapy for the treatment of IMT with ALK Translocation.
    • According to NCCN Practice Guidelines for NSCLC, Xalkori has a category 2A recommendation with the following: 1) single agent therapy for recurrence or metastasis in patients with ROS1- or ALK-positive tumors of nonsquamous cell histology as first-line therapy, 2)second-line therapy for progressive asymptomatic disease, symptomatic isolated lesions, or multiple symptomatic brain lesions, and 3) activity against MET amplifications in lung cancer. MET is thought to give rise to a metastatic lesion with cellular characteristics of the original tumor.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    AlecensaR (alectinibi)*

    ALK positive NSCLC:
    600 mg PO BID

    1200 mg/day

    ZykadiaR (ceritinib)*

    ALK positive NSCLC:
    750 mg PO QD

    750 mg/day

    cisplatin (Platinol-AQR)
    carboplatin (ParaplatinR)
    paclitaxel (TaxolR)
    docetaxel (TaxotereR)
    vinorelbine (NavelbineR)
    GemzarR (gemcitabine)
    etoposide (ToposarR, VepesidR)
    irinotecan (CamptosarR)
    vinblastine (VelbanR)
    AvastinR (bevacizumab)*
    AlimtaR (pemetrexed)

    NSCLC:
    Various doses

    Number of cycles vary

    * 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 2016.
    2. Clinical Pharmacology Web site. Available at: http://www.clinicalpharmacology-ip.com/default.aspx. Accessed June 17, 2015.
    3. 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.
    4. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer Version 4.2016. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed April 1, 2016.
    5. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 17, 2015.
    6. DRUGDEXR System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 15, 2014.
    7. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. 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.