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Prior Authorization Protocol

NEULASTAR (pegfilgrastim)

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:
    • To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
    • Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)
  2. Health Net Approved Indications and Usage Guidelines:
    • Patient is receiving myelosuppressive chemotherapy (primary prophylaxis)
    AND
    • Chemotherapy regimen is expected to cause febrile neutropenia

    OR

    • Patient is at higher risk for chemotherapy-induced infectious complications including, but not limited to one of the following:
      1. Pre-existing neutropenia due to disease, extensive prior chemotherapy
      2. Decreased immune function
      3. Previous radiation to areas containing large amounts of bone marrow
      4. Active tissue infection(s)
      5. Open wound(s)
      6. Age greater than 65 years old

    OR

    • Patient is receiving myelosuppressive chemotherapy (secondary prophylaxis)

    AND

    • Patient has a history of febrile neutropenia following a previous course of chemotherapy
    OR
    • To mobilize peripheral-blood progenitor cells (PBPC) prior to autologous transplantation

    OR

    • Patient is acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)
  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:
    • The development of febrile neutropenia is a common dose-limiting toxicity of many chemotherapy regimens. This risk is directly related to the intensity of the chemotherapy regimen. Chemotherapy regimens that have an incidence of febrile neutropenia greater than 20% in clinical trials in chemotherapy naove patients are considered by the NCCN panel at high risk. Prophylaxis with myeloid growth factors is recommended at this level of risk. According to NCCN practice guidelines, in addition to chemotherapy regimens, other risk factors such as: treatment-related, patient related, cancer-related, and comorbidities have been associated with an increased risk of febrile neutropenia. Therefore, the type of chemotherapy regimen is only one component of the risk assessment.
    • Per NCCN practice guidelines, there are insufficient data to support use of Neulasta with chemotherapy schedules given more frequently than every 2 weeks.
    • There is currently a lack of evidence to support use of Neulasta for treatment of febrile neutropenia.
    • Following myeloablative chemotherapy, Neulasta was effective and safe for mobilizing blood progenitor cells before autologous transplantation in patients with hematological malignancies (class IIa recommendation per Drugdex).
    • ASCO 2006 clinical practice guidelines for the appropriate use of hematopoietic colony stimulating factors (CSF) in patients with cancer recommend the use of CSFs as adjunctive therapy for progenitor cell transplantation. CSFs may be used, often in conjunction with chemotherapy, to mobilize peripheral-blood progenitor cells (PBPC) for leukaphereis collection and to shorten the neutropenic period after cytoreduction and an autologous bone marrow transplantation. Post-transplant use of granulocyte-colony stimulating factor (G-CSF, filgrastim) after an autologous PBPC transplant has been found to shorten hospitalization and reduce overall medical costs.
    • Recent evidence supports dose reduction of pegylated interferon according to FDA approved labeling as treatment for neutropenia occurring in hepatitis C patients treated with combination therapy (pegylated interferon + ribavirin). Treatment with Neulasta is not FDA approved or recommended by current hepatitis C treatment guidelines.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    NeupogenR (filgrastim)

    5 mcg/kg/day SC/IV/IVF

    Up to 10 mcg/kg/day or 14 days per chemotherapy cycle

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

    Neulasta

    Myelosuppressive chemotherapy
    6 mg SC once per chemotherapy cycle.
    Mobilization of peripheral-blood progenitor cells
    6 mg or 12 mg SC once

    Patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome):
    6 mg SC, two doses one week apart
    Administer the first dose as soon as suspected or confirmed exposure to radiation levels greater than 2 gray
    Do not administer within 7 days prior to next administration of cytotoxic
    chemotherapy and within 24 hours after administration of cytotoxic chemotherapy.

    Myelosuppressive chemotherapy
    1 dose per cycle of chemotherapy
    Mobilization of peripheral-blood progenitor cells
    Once per transplant

    Patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome):
    2 doses
  7. Product Availability:

    6 mg/0.6 ml prefilled syringe

  8. References:
    1. Neulasta [Prescribing Information]. Thousand Oaks, CA: Amgen; November 2015.
    2. American Society of Clinical Oncology 2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline. J Clin Oncology. 2006; 24: 3187-3205.
    3. National Comprehensive Cancer Network.Myeloid Growth Factors Version 2.2014. Available at: http://www.nccn.org/professionals/physician_gls/pdf/myeloid_growth.pdf. Accessed June 11, 2015.
    4. Neulasta. In: DrugPointsR System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 10, 2015.
    5. Neulasta. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 10, 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.