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Prior Authorization Protocol

LEUKINER (sargramostim)

NATL

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:
    • Following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death. The safety and efficacy of Leukine have not been assessed in patients with AML under 55 years of age.
    • For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
    • For acceleration of myeloid recovery in patients with Non-Hodgkin's Lymphoma (NHL), Acute Lymphoblastic Leukemia (ALL), and Hodgkin's disease undergoing autologous bone marrow transplantation (BMT).
    • For acceleration of myeloid recovery in patients undergoing allogeneic BMT from Human Lymphocyte Antigen (HLA)-matched related donors.
    • For patients who have undergone allogeneic or autologous BMT in whom engraftment is delayed or has failed.
  2. Health Net Approved Indications and Usage Guidelines:
    • Patient must have one of the above listed FDA approved indications
    AND
    • Failure or clinically significant adverse effects to NeupogenR or ZarxioR
  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:
    • Because of potential sensitivity of rapidly dividing hematopoietic progenitor cells, Leukine should not be administered simultaneously with cytotoxic chemotherapy or radiotherapy or within 24 hours preceding or following chemotherapy or radiotherapy.
    • Use Leukine with caution in patients with pre-existing fluid retention, pulmonary infiltrates, or CHF.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    NeupogenR (filgrastim)*, ZarxioR (filgrastim-sndz)*

    Acute myeloid leukemia:
    5 mcg/kg/day

    Bone marrow transplant:
    10 mcg/kg/day

    Peripheral blood progenitor cell collection:
    10 mcg/kg/day by SC injection
    Acute myeloid leukemia
    5 mcg/kg/day
    Bone marrow transplant,
    Peripheral blood progenitor cell collection
    10 mcg/kg/day
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Leukine

    Acute myeloid leukemia following induction chemotherapy:
    250 mcg/m2/day IV over 4 hr starting approximately day 11 or 4 days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with < 5% blasts.

    Peripheral blood stem cell harvest, mobilization:
    250 mcg/m2/day IV over 24 hours or SC once daily

    Myeloid reconstitution after autologous or allogeneic bone marrow transplant:
    250 mcg/m2/day as a 2-hour IV infusion beginning 2 to 4 hours after the bone marrow infusion, and not less than 24 hours after the last dose of chemotherapy or radiotherapy. 

    Bone marrow transplant failure or engraftment delay:
    250-500 mcg/m2/day for 14 days as a 2-hour IV infusion. The dose can be repeated after 7 days off therapy if engraftment has not occurred.
    Acute myeloid leukemia following induction chemotherapy
    Up to 42 days
    Peripheral blood stem cell harvest, mobilization
    Length of benefit
    Myeloid reconstitution after autologous or allogeneic bone marrow transplant
    Length of benefit
    Bone marrow transplant failure or engraftment delay
    Up to 42 days
  7. Product Availability:
    Vial for injection: 500 mcg/ml, 1 ml
    Lyophilized powder for injection: 250 mcg
  8. References:
    1. Leukine [Prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC; April 2013.
    2. American Society of Clinical Oncology Recommendations for the use of hematopoietic colony- stimulating factors: Evidence-based, clinical practice guidelines. J Clin Oncology 1994;12:11: 2471-2508..
    3. Leukine. In: DrugPointsR System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 2016.
    4. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Myeloid growth factors, Version 1.2016. Available at: http://www.nccn.org. Accessed May 2016.
    5. Leukine. American Hospital Formulary Service Drug Information. Available at:http://www.medicinescomplete.com/mc/ahfs/current/. Accessed May 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.