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Prior Authorization Protocol

TARCEVAR (erlotinib)

NATL

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:
    • 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.
    • Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
    • Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
    • First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
  2. Health Net Approved Indications and Usage Guidelines:
    Non-small cell lung cancer
    • 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

      • Failure or clinically significant adverse effects to platinum-based chemotherapy regimen (e.g., cisplatin, carboplatin)
    Pancreatic cancer
    • Diagnosis of locally advanced, unresectable or metastatic pancreatic cancer
    AND
    • Must be used in combination with gemcitabine
  3. Coverage is Not Authorized For:
    • First-line therapy for NSCLC in combination with platinum-based chemotherapy
    • 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:
    • National Comprehensive Cancer Network (NCCN) Practice Guidelines for NSCLC recommend platinum-based chemotherapy regimens for first-line therapy for advanced NSCLC.
    • Per NCCN guidelines (category 2A), Tarceva is recommended as first line therapy in patients with advanced, recurrent, or metastatic nonsquamous NSCLC who have known active EGFR mutation or gene amplification regardless of their performance status. This recommendation is based on the results of a phase III trial in which patients with EGFR mutations who received gefitinib had increased progression free survival (25% vs. 7%), response rate (71%) and quality of life and fewer side effects when compared to those receiving chemotherapy (carboplatin/paclitaxel).
    • Results from 2 placebo-controlled, randomized, phase III trials showed no clinical benefit with concurrent administration of Tarceva with platinum-based chemotherapy.
    • Contraindications to platinum-based chemotherapy regimens may include pre-existing neuropathy, and other complicating comorbidities (e.g. transplant patients; patients with chronic renal insufficiency).
    • NCCN Practice Guidelines do not recommend systemic, cytotoxic chemotherapy for patients of any age with a Performance Status (PS) score of 3-4 for NSCLC except Tarceva for EGFR mutation positive patients.
    ECOG Performance Status Scale

    Score
    Description
    0
    Normal Activity
    1
    Symptoms but nearly fully ambulatory
    2
    Ambulatory but bedtime required during normal daytime (< 50%)
    3
    Confined to bed > 50% of waking hours
    4
    Unable to get out of bed

    • Tarceva monotherapy for pancreatic cancer has not been studied.
    • Colorectal, head, neck, prostate, and ovarian cancer are class III recommendations in Micromedex.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    cisplatin
    carboplatin
    paclitaxel
    docetaxel
    vinorelbine
    gemcitabine
    etoposide
    irinotecan
    vinblastine
    mitomycin
    ifosfamide
    AlimtaR (2nd line)

    NSCLC

    Various doses



    Number of cycles varies

    gemcitabine
    gemcitabine + cisplatin
    gemcitabine + oxaliplatin
    5-FU
    Pancreatic cancer

    Various doses



    Number of cycles varies

    GilotrifTM (afatinib)

    NSCLC  EGFR mutation
    40 mg PO QD

    40 mg/day

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

    Tarceva

    NSCLC
    150 mg PO QD
    Pancreatic cancer
    100 mg PO QD in combination with gemcitabine.

    Length of benefit or until disease progression

  7. Product Availability:

    Tablets: 25 mg, 100 mg, 150 mg

  8. References:
    1. Tarceva [Prescribing Information]. Farmingdale, NY: OSI Pharmaceuticals, Inc. April 2014.
    2. Perez-Soler R, Chachoua A, Hammond LA, et al. Determinants of tumor response and survival with erlotinib in patients with non-small cell lung cancer. J Clin Oncol 2004;22:3238-3247.
    3. Shepherd FA, Pereira J, Ciuleanu TE, et al. A randomized placebo-controlled trial of erlotinib in patients with advanced non-small cell lung cancer (NSCLC) following failure of 1st line or 2nd line chemotherapy. National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) trial BR.21. Presented at the 40th annual meeting of the American Society of Clinical Oncology, June 7, 2004, New Orleans, Louisiana.
    4. Oken M, Creech RH, et al. Toxicity and response criteria of the eastern cooperative oncology group. Am J Clin Oncol. 1982;5:649-655.
    5. Gatzemeier U, Pluzanska A, Szczesna A, et al. Results of a phase III trial of erlotinib (OSI-
    774) combined with cisplatin and gemcitabine (GC) chemotherapy in advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol. 2004; 23:617.
    6. Herbst RS, Prager D, Hermann R, et al. TRIBUTE-A phase III trial of erlotinib HCL (OSI-774) Combined with carboplatin and paclitaxel (CP) chemotherapy in advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol. 2004; 23:617.
    7. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. Version 2.2013. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 1, 2014.
    8. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed July 1, 2014.
    9. Micromedex Healthcare Series. Micromedex Web site. Available at http://www.thomsonhc.com. Accessed July 1, 2014.
    10. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed July 1, 2014.
    11. Clinical Pharmacology. Available at: http://www.clinicalpharmacology-ip.com/Default.aspx. Accessed July 1, 2014.
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.