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Prior Authorization Protocol
TAFINLARR (dabrafenib)


HNMC
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 unresectable or metastatic melanoma with the BRAF V600E mutation as detected by an FDA-approved test
    • In combination with trametinib is indicated 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:
    Unresectable or metastatic melanoma with BRAF V600E mutation
    • Diagnosis of unresectable or metastatic melanoma
    AND
    • Positive for the BRAF V600E mutation detected by an FDA-approved test

    OR

    • Prescribed by an Oncologist
    Unresectable or metastatic melanoma with BRAF V600K mutation
    • Diagnosis of unresectable or metastatic melanoma
    AND
    • Positive for the BRAF V600K mutation detected by an FDA-approved test AND used in combination with Mekinist
    OR
    • Prescribed by an Oncologist
  3. Coverage is Not Authorized For:
    • Patients with wild-type BRAF melanoma
    • 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:
    • Nearly half of patients with melanoma have a BRAF mutation gene. The most common forms of the BRAF mutation are V600E (80-90%) V600K (10-20%).
    • Tafinlar can potentiate the activity of the MAPK pathway in cells with wild-type BRAF and could accelerate the growth of some tumors with wild-type BRAF.
    • The current NCCN guideline recommends that the preferred therapy for patients with metastatic melanoma is participation in a clinical trial, even though Zelboraf, Yervoy, and Tafinlar received a category 1 recommendation.
    • Tafinlar is not FDA approved to treat patients with V600K mutations. Studies with less than 20 patients showed a partial response rate ranging from 13 to 25 percent. Mekinist is FDA approved to treat V600K mutations.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    YervoyTM (ipilimumab)*

    3 mg/kg IV every 3 weeks for 4 doses

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

    dacarbazine (DTIC-DomeR)*

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

    Dose can vary depending on chemotherapy regimen

    ZelborafR (vemurafenib)*

    960 mg PO BID

    1920 mg/day

    Mekinist (trametinib)

    2 mg PO QD

    2 mg PO QD

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

    Tafinlar

    150 mg PO BID

    Length of Benefit

  7. Product Availability:
    Tafinlar: 75, 50 mg tablets
  8. References:
    1. Tafinlar [Prescribing information]. Research Triangle Park, NC. GlaxoSmithKline. January 2014.
    2. National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology-v.2.2013; Available at: http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Accessed June 12, 2013.
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.