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Prior Authorization Protocol
TASIGNAR (nilotinib)


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:
    • For the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in chronic phase
    • For the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant to or intolerant to prior therapy that included GleevecR
  2. Health Net Approved Indications and Usage Guidelines:
    • Patient must have one of the following diagnoses:
      • Patient is newly diagnosed with Ph+ CML in chronic phase
    OR
    • Patient has a diagnosis of resistant or intolerant chronic or accelerated phase Ph+ CML
    AND
    • Failure or clinically significant adverse effects to Gleevec
    OR
    • Patient has a diagnosis of soft tissue sarcoma-gastrointestinal stromal tumor (GIST)
    AND
    • Failure or clinically significant adverse effects to Gleevec or SutentR
    OR
    • Patient has diagnosis of Acute Lymphoblastic Leukemia (ALL) according to the NCCN guidelines (Class 2A recommendation)
  3. Coverage is Not Authorized For:
    • Patients with hypokalemia, hypomagnesemia, or long QT syndrome
    • 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:
    • Tasigna prolongs the QT interval. It has a black box warning reporting sudden deaths in patients receiving Tasigna and it should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome. ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.
    • Tasigna is the only protein tyrosine kinase inhibitor that is not approved for blast crisis of CML. CML is a myeloproliferative disorder that arises from genetic defects in hematopoietic stem cells, and is associated with an increased production of mature and immature blood cells, which progresses through three "phases". Most patients present in chronic phase, progress through an accelerated phase (although some patients skip this phase), and then die after entering a brief phase, blast crisis.
    • Per NCCN Drugs and Biologics Compendium, Tasigna has a category 2A rating for soft tissue sarcoma-gastrointesingal stromal tumors (GIST) for progressive disease after patient is no longer receiving benefit from Gleevec, Sutent, or StivargaR.
    • Fetal harm can occur when administered to a pregnant woman. Sexually active female patients should use effective contraception during treatment and should be advised not to become pregnant when taking Tasigna.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    GleevecR (imatinib)

    Newly diagnosed Ph+ CML in chronic phase:
    400 mg PO QD
    Ph+ CML blast or accelerated phase: 600 mg PO QD
    GIST: 400 mg PO QD

    800 mg/day

    SprycelR (dasatinib)*

    Newly diagnosed Ph+ CML in chronic phase: 100 mg PO QD

    Ph+ CML blast or accelerated phase: 140 mg PO QD

    180 mg/day

    SutentR (sunitinib)*

    GIST: 50 mg po QD

    87.5 mg/day

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

    Tasigna

    Newly diagnosed Ph+ CML:
    300 mg PO BID
    Resistant or intolerant Ph+ CML chronic or accelerated phase:
    400 mg PO BID

    Treatment continues until no longer clinically beneficial or
    until unacceptable toxicity occurs.

    Length of Benefit

  7. Product Availability:
    Capsules: 150 mg and 200 mg - carton of 4 blister packs of (4x28) and blisters of 28 capsules.
  8. References:
    1. Tasigna [Prescribing Information] East Hanover, NJ: Novartis Pharmaceuticals; January 2014.
    2. National Comprehensive Cancer Network. Chronic Myelogenous Leukemia Version 2.2012. Available at http://www.nccn.org. Accessed June 16, 2014..
    3. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed June 16, 2014..
    4. Micromedex Healthcare Series. Micromedex Web site. Available at http://www.thomsonhc.com. Accessed June .13, 2014.
    5. Tasigna. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 13, 2014.
    6. National Comprehensive Cancer Network. Soft Tissue Sarcoma. Version.2.2012. Available at http://www.nccn.org. Accessed June 16, 2014..
    7. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed June 13, 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.