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Prior Authorization Protocol
MEKINISTTM (trametinib)


HNCA
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:
    • As a single agent and in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of unresectable or metastatic melanoma
    AND
    • Positive for the BRAF V600E or V600K mutation detected by an FDA-approved test
    OR
    • Prescribed by 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.
    • Monotherapy for patients who have disease progression on prior BRAF inhibitor therapy
  4. General Information:
    • Mekinist is not indicated for the treatment of patients who have received prior BRAF inhibitor therapy. The clinical activity of Mekinist was evaluated in a single-arm, multicenter, international trial in 40 patients with BRAF V600E or V600K mutation-positive, unresectable or metastatic melanoma who had received prior treatment with a BRAF inhibitor. No patient in this trial achieved a confirmed partial or complete response. Because of this lack of clinical activity, the manufacturer does not recommend using Mekinist in those patients who have received prior BRAF inhibitor therapy.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    dacarbazine (Dtic-DomeR)

    250 mg/m2 IV days 1-5 every 3 weeks

    Dose can vary depending on chemotherapy regimen

    YervoyTM (ipilimumab)

    3 mg/kg IV every 3 weeks for 4 doses

    Limited to 4 lifetime doses within 16 weeks of the initial dose

    ZelborafR (vemurafenib)

    960 mg PO BID

    1920 mg/day

    TafinlarR (dabrafenib)*

    150 mg PO BID

    300 mg/day

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

    Mekinist

    2 mg PO once daily

    Length of Benefit

  7. Product Availability:
    Mekinist: 0.5 mg, 1 mg, 2 mg tablets
  8. References:
    1. Mekinist [Prescribing information]. Research Triangle Park, NC. GlaxoSmithKline. January 2014.
    2. National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology 3.2015; Available at: http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Accessed June 3, 2015.
    3. Micromedex Healthcare Series. Micromedex Web site. Available at http://www.thomsonhc.com. Accessed June 3, 2015.
    4. Clinical Pharmacology. Available at: http://www.clinicalpharmacology-ip.com/Default.aspx. Accessed June 3, 2015.
    5. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 3, 2014.
    6. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed June 3, 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.