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Prior Authorization Protocol

TECENTRIQTM (atezolizumab)



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:
    • For the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
      • Have disease progression during or following platinum-containing chemotherapy
      • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of locally advanced or metastatic urothelial carcinoma

    AND

    • Failure or clinically significant adverse effects to platinum-containing chemotherapy (e.g., cisplatin/methotrexate/vinblastine/doxorubicin or cisplatin/gemcitabine or carboplatin/gemcitabine)
  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:
    • Locally advanced urothelial carcinoma is defined as cancer that has spread from where it started to nearby tissue or lymph nodes.
    • Metastatic urothelial carcinoma is defined as cancer that has spread from the primary site to other places in the body.
    • Having disease progression would constitute a failure to current or previous platinum-containing chemotherapy.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    ddMVAC: dose-dense methotrexate + vinblastine + doxorubicin + cisplatin

    methotrexate 30 mg/m2 IV on day 1
    vinblastine 3 mg/m2 IV on day 2
    doxorubicin 30 mg/m2 IV on day 2
    cisplatin 70 mg/m2 IV on day 2

    Repeat every 14 days for four cycles

    Four cycles of 14 days

    GC: gemcitabine + cisplatin (GemzarR + cisplatin)

    gemcitabine 1000 mg/m2 IV on days 1, 8, 15
    cisplatin 70 mg/m2 IV on day 2

    Repeat every 28 days for six cycles

    Six cycles of 28 days

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

    Tecentriq

    1200 mg IV every 3 weeks

    HNCA:
    6 months or to members renewal date, whichever is longer

    NATL:
    Length of benefit or until disease progression

  7. Product Availability:

    Single-dose vial: 1200 mg/20 mL (60 mg/mL) solution

  8. References:

    1. Tecentriq [Prescribing Information]. South San Francisco, CA: Genentech, Inc.; May 2016.
    2. Rosenberg JE, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicenter, phase 2 trial. Lancet 2016;387:1909-20.
    3. National Comprehensive Cancer Network. Bladder Cancer. Version 1.2016, dated 4/4/16. Accessed from https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf, June 2016.

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.
Draft Prepared: 13-JUN-16 AM
Approved By Health Net National P&T:
Revised: 05-JUL-16 AM