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Prior Authorization Protocol

ARANESPR (darbepoetin alfa)


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:
    • Treatment of anemia associated with chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
    • Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two months of planned chemotherapy.
    • Limitations of Use:
      • Has not been shown to improve quality of life, fatigue, or patient well-being.
      • It is not indicated for use:
        • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
        • In patients with cancer receiving myelosuppressive chemotherapy when the outcome is cure.
        • As a substitute for red blood cells (RBC) transfusions in patients who require immediate correction of anemia.
  2. Health Net Approved Indications and Usage Guidelines:
    • Patient is diagnosed with one of the following:
      • Anemia of CKD (patient may or may not be on dialysis)
      • Chemotherapy-induced anemia in patients with non-myeloid malignancies
      • Myelodysplastic syndrome with erythropoietin ≤ 500 mU/ml and risk category low or intermediate-1-risk (INT-1). (International Prognostic Scoring System [IPSS] score 0 to 1)

    AND

    • Hemoglobin (Hgb) values prior to initiation of therapy are*
    *If transfusion was required previously, Hgb values prior to transfusion

    Hgb < 11 gm/dL
    • Myelodysplastic syndrome
    Hgb < 10 gm/dL
    • Chemotherapy-induced anemia
    • Anemia of CKD

    AND

    • Documentation of adequate iron stores drawn within 60 days of the request must be submitted prior to initiation of therapy and when Aranesp dose is increased (transferrin saturation should be > 20% and ferritin > 100 ng/ml).
    AND
    • Failure or clinically significant adverse effects to ProcritR
  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:
    • Transferrin saturation % = [serum iron divided by total iron binding capacity (TIBC)] x 100
    • American Society of Clinical Oncology/American Society of Hematology 2010 Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin states: The use of epoetin or darbepoetin is recommended as a treatment option for patients with chemotherapy- associated anemia and an Hgb concentration that has decreased to less than 10 g/dL to decrease transfusions. An optimal target Hgb concentration cannot be definitively determined from the available literature. Modification to reduce the erythropoiesis-stimulating agent (ESA) dose is appropriate when Hgb reaches a level sufficient to avoid transfusion or the increase exceeds 1 g/dL in any 2-week period to avoid excessive ESA exposure.
    • Because it takes several days for erythropoiesis, a clinically significant increase in hematocrit is usually not observed in less than 2 weeks and may require up to 6 weeks in some patients.
    • Black box warnings include:
      • Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious cardiovascular events and stroke when administered ESAs to target hemoglobin levels of greater than 11 g/dL. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Use the lowest dose sufficient to reduce the need for red blood cell transfusions.
      • Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion. Prescribers and hospitals must enroll in and comply with the ESA APRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology Program to prescribe and/or dispense Aranesp. Use ESAs only for treatment of anemia from myelosuppressive chemotherapy. ESAs are not indicated for patients receiveing myelosuppressive therapy when the anticipated outcome is cure. Discontinue following the completion of a chemotherapy course.
    • Clinical response to Aranesp in the treatment of myelodysplastic syndrome may include any of the following: Hgb increase of at least 1 g/dL from baseline or maintenance of Hgb between 10-12 g/dL.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    ProcritR (epoetin alfa)* (preferred) and EpogenR (epoetin alfa)*
    CKD patients
    Adults
    50-100 units/kg IV or SC TIW
    Pediatrics
    50 units/kg IV or SC TIW
    Cancer Patients on Chemotherapy
    Initial Dose
    150 units/kg IV or SC TIW or
    40,000 units/week IV or SC
    The dose should be individualized, and lowest dose should be used to reduce the need for RBC transfusions.
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Aranesp

    Anemia in CKD patients on dialysis
    Initial
    0.45 mcg/kg IV or SC weekly, or 0.75 mcg/kg once every 2 weeks.
    IV route is recommended for patients on hemodialysis.
    If the Hgb level approaches or exceeds 11 g/dL, reduce or interrupt the dose.
    Anemia in CKD patients not on dialysis
    Initial
    0.45 mcg/kg IV or SC once every 4 weeks
    If the Hgb level exceeds 10 g/dL, reduce or interrupt the dose and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions

    CKD (dialysis and non-dialysis patients)
    Do not increase dose more frequently than once every 4 weeks.
    Decreases in dose can occur more frequently.
    If Hgb rises rapidly (e.g. more than 1 g/dL in any 2 week period), reduce the dose by 25% or more as needed to reduce rapid responses.
    For patients who do not respond adequately, if the Hgb has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
    Use the lowest dose that will maintain a Hgb level sufficient to reduce the need for RBC transfusions.
    Initial:
    3 months.
    For patient with CKD on dialysis:
    Dose must be reduced or interrupted if the Hgb level approaches or exceeds 11 g/dL.
    For patient with CKD NOT on dialysis:
    Dose must be reduced or interrupted if the Hgb level approaches or exceeds 10 g/dL.

    Continued treatment will be approved every 6 months or to members renewal period, whichever is sooner, upon receiving Hgb, transferrin saturation and ferritin values. Documentation of transferrin saturation greater than or equal to 20% and ferritin greater than or equal to 100 ng/ml within 60 days of the request must be submitted prior to dose increase.

    Additional dose escalations for patients who do not respond adequately over a 12-week escalation period will not be approved.

    Aranesp

    Chemotherapy-induced anemia:
    Starting dose is 2.25 mcg/kg SC once weekly or
    500 mcg SC every 3 weeks until completion of chemotherapy course

    If Hgb increases greater than 1 g/dL in any 2 week period or
    if Hgb reaches a level needed to avoid RBC transfusion,
    reduce dose by 40% (both weekly and every 3 week schedule)

    If Hgb exceeds a level needed to avoid RBC transfusion,
    withhold dose until Hgb approaches a level where RBC transfusions may be required.
    Then reinitiate at a dose of 40% below the previous
    dose (both weekly and every 3 week schedule).

    If Hgb increases by less than 1 g/dL and remains below
    10 g/dL after 6 weeks of therapy, increase dose to 4.5mcg/kg/week (weekly schedule).
    No dose adjustment is needed for every 3 week schedule.

    Discontinue Aranesp if there is no response as measured by the Hgb levels or
    if RBC transfusions are still required after 8 weeks of therapy
    or following completion of a chemotherapy course.

    Use the lowest dose necessary to avoid RBC transfusions.

    Chemotherapy-induced anemia:
    Authorized until the completion of chemotherapy course, 6 months or to member's renewal period, whichever is sooner.

    Dose must be reduced or interrupted if the Hgb level approaches or exceeds 12 g/dL.

    Documentation of transferrin saturation greater than or equal to 20% and ferritin greater than or equal to 100 ng/ml within 60 days of the request must be submitted prior to dose increase.

    Aranesp

    Myelodysplastic syndromes:
    150-300 mcg SC once weekly
    Myelodysplastic syndromes:
    6 months.

    Dose must be reduced or interrupted if the Hgb level approaches or exceeds 12 g/dL.

    Continued treatment will be approved every 6 months or to member's renewal period, whichever is sooner, upon receiving documentation of clinical response (see general information section).

    Documentation of transferrin saturation greater than or equal to 20% and ferritin greater than or equal to 100 ng/ml within 60 days of the request must be submitted prior to dose increase.
  7. Product Availability:
    • Vial for injection (single dose, polysorbate): 25 mcg/ml, 40 mcg/ml, 60 mcg/ml, 100 mg/ml, 150 mcg/0.75 ml, 200 mcg/ml, 300 mcg/ml, 500 mcg/ml
    • Single- Dose Prefilled syringes: (single dose polysorbate): 10 mcg/0.4mL, 25 mcg/0.42 ml, 40 mcg/0.4 ml, 60 mcg/0.3 ml, 100 mcg/0.5 ml, 150 mcg/ 0.3 ml, 200 mcg/0.4 ml, 300 mcg/0.6 ml, 500 mcg/ml
  8. References:
    1. Aranesp [Prescribing information]. Thousand Oaks, CA: Amgen Inc;March 2015.
    2. Procrit [Prescribing information]. Thousand Oaks, CA: Amgen Inc; December 2013.
    3. Smith R. Applications of darbepoietin-a, a novel erythropoiesis-stimulating protein, in oncology. Curr Opin Hematol. 2002;9:228-233.
    4. Kidney Disease Outcomes Quality Initiative. Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease, 2006. Available at: http://www2.kidney.org/professionals/KDOQI/guidelines_anemiaUP. Accessed May 21, 2015.
    5. National Comprehensive Cancer Network. Cancer and Chemotherapy Induced Anemia Version 2.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/anemia.pdf. Accessed May 21, 2015.
    6. National Comprehensive Cancer Network. Myelodysplastic Syndrome Version 2.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/mds.pdf. Accessed May 21, 2015.
    7. FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs). Available at: http://www.fda.gov/,. Accessed May 21, 2015.
    8. Rizzo JD, Brouwers M, Hurley P, et al. American Society of Clinical Oncology/American Society of Hematology 2010 Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin in Adult Patients with Cancer. JCO; 2010; 28(33): 4996-5010.
    9. Aranesp. In: DrugPointsR System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 21, 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.