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Prior Authorization Protocol
FERRIPROXR (deferiprone)

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:
    • For treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of transfusional iron overload
    AND
    • Absolute neutrophil count > 1500/microliter (1.5 x 109/L or 1500/mm3)

    AND

    • Failure or clinically significant adverse effects to DesferalR, ExjadeR, or JadenuTM
  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:
    • Ferriprox can cause neutropenia and agranulocytosis. Measure the absolute neutrophil count (ANC) before starting Ferriprox and monitor the ANC weekly on therapy. Interrupt Ferriprox therapy if neutropenia develops (ANC < 1.5 x 109/L).
    • Ferriprox may increase ALT values. Monitor ALT monthly during therapy with Ferriprox and consider interruption of therapy if there is a persistent increase in the serum transaminase levels.
    • Ferriprox may decrease plasma zinc concentrations. Monitor plasma zinc, and supplement in the event of a deficiency.
    • A multicentre randomized open-label trial was designed to assess the effectiveness of long-term sequential deferiprone-deferoxamine (DFO-DFP) versus DFP alone to treat thalassaemia major. The decrease of serum ferritin levels during the treatment period was statistically significant higher in sequential DFP-DFO patients compared with DFP-alone patients (P = 0.005). Kaplan-Meier survival analysis for the two chelation treatments did not show any statistically significant differences (long-rank test, P = 0.3145).
    • Evidence exists to support the use of combination therapy with FerriproxR (deferiprone) and DesferalR (deferoxamine) in patients with severe iron overload or overt iron-realted morbiditiy.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    DesferalR
    (deferoxamine)

    1-2 gm (20-40 mg/kg/day) SC infused over 8-24 hr daily
    OR
    0.5-1 gm IM daily, plus 2 gm IV infusion per each unit of transfused blood
    1 g/day with no transfusion,
    6 g/day with transfusion

    ExjadeR
    (deferasirox)*

    20 to 40 mg/kg PO daily

    40 mg/kg/day

    JadenuTM
    (deferasirox)

    14 mg/kg (calculated to nearest whole tablet) PO QD. Increase dose in steps of 3.5 to 7 mg/kg to individual response.

    28 mg/kg/day

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

    Ferriprox

    25 to 33 mg/kg PO TID for a total daily dose of 75 to 99 mg/kg/day

    Length of Benefit

  7. Product Availability:
    Tablet: 500 mg
  8. References:
    1. Ferriprox [Prescribing Information]. Rockville, MD: ApoPharma USA, Inc; February 2015.
    2. Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 13, 2015.
    3. MedicinesComplete [online]. London: Pharmaceutical Press. Available at: http://www.medicinescomplete.com. Accessed June 13, 2015.
    4. Maggio A, Vitrano A, Capra M, et al. Long-term sequential deferiprone-deferoxamine versus deferiprone alone for thalassaemia major patients: a randomized clinical trial. Br J Haematol. 2009;145:245-54.
    5. Angelucci E, Barosi G, Camaschella C, et al. Italian Society of Hematology practice guidelines for the management of iron overload in thalassemia major and related disorders. Haematologica. 2008;93(5):741-52.
    6. Children`s Hospital and Research Center Oakland. Standards of Care Guidelines for Thalassemia 2012. Available at: http://www.thalassemia.com. Accessed June 13, 2015.
    7. Clinical Pharmacology Website. Available at http://www.clinicalpharmacology-ip.com. Accessed June 13, 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.