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Prior Authorization Protocol
IRESSAR (gefitinib)
NATL
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:
    • First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of NSCLC
    AND
    • Patient has known active EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test
    OR
    • Prescribed by an Oncologist
  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).
    • According to National Comprehensive Cancer Network (NCCN) Practice Guidelines, treatment of NSCLC (with category 1 NCCN recommendation) is further categorized by histological findings with gene alteration and rearrangement: 1) EGFR mutation and ALK negative - platinum-based chemotherapy (e.g. cisplatin+AlimtaR), 2) EGFR mutation positive - GilotrifTM, TarcevaR, IressaR, and 3) ALK positive  XalkoriR, ZykadiaTM.
    • Iressa is currently being studied for locally advanced or recurrent squamous cell skin cancer, acute myelogenous leukemia, glioblastoma multiforme, refractory solid tumors, advanced head & neck cancer, advanced unresectable hepatocellular carcinoma (liver cancer), advanced renal cell carcinoma, metastatic breast cancer, and metastatic or locally recurrent colorectal cancer.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    GilotrifTM (afatinib) *

    NSCLC  EGFR mutation:
    40 mg PO QD

    40 mg/day

    TarcevaR (erlotinib) *

    NSCLC  EGFR mutation:
    150 mg PO QD

    150 mg/day

    cisplatin
    carboplatin
    paclitaxel
    docetaxel
    vinorelbine
    gemcitabine
    etoposide
    irinotecan
    vinblastine
    mitomycin
    ifosfamide
    AvastinR
    AlimtaR (2nd line)
    NSCLC
    Various doses

    Number of cycles varies

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

    Iressa

    NSCLC  EGFR mutation:
    250 mg PO QD

    Length of benefit or until disease progression

  7. Product Availability:

    Tables: 250 mg

  8. References:
    1. Iressa [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. July 2015.
    2. Douillard JY, Ostoros G, Cobo M, et al. First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study. Br J Cancer (2014) 110, 5562.
    3. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatinpaclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009;361:947-57.
    4. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. Version 7.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 18, 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.