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Prior Authorization Protocol
PURIXANTM (mercaptopurine oral suspension)

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:
    • For the treatment of patients with acute lymphoblastic leukemia (ALL) as a component of a combination maintenance therapy regimen.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of acute lymphoblastic leukemia
    AND
    • Failure or clinically significant adverse effects to mercaptopurine tablets
    AND
    • Member has a documented swallowing disorder or an inability to swallow tablets or capsules
  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:
    • Typical maintenance therapy regimen consists of daily 6-mercaptopurine, weekly methotrexate, and monthly vincristine/prednisone pulses for 2-3 years.
    • Oral mercaptopurine can have highly variable drug and metabolite concentrations as many factors (e.g. thiopurine S-methyl transferase (TPMT) polymorphisms and drug-drug-interactions with other chemotherapeutic agents) can affect bioavailability and impact the ability of maintenance regimens to prevent disease relapse.
    • Mercaptopurine dose adjustments may be needed to manage clinically significant adverse effects (e.g. myelosuppression including anemia, neutropenia, lymphopenia and thrombocytopenia). Mercaptopurine oral suspension may be more amendable to dose adjustments in patients who continue to have poor clinical response despite dose adjustments with the tablet form.
    • The use of mercaptopurine for Chrons disease and ulcerative colitis has the following recommendations as an off-label use: AHFS states mercaptopurine is effective in the management of fistulizing Crohns disease, and it is effective in treating pediatric patients with intractable Crohns disease who have been refractory to corticosteroids, sulfasalazine, and/or anti-infectives, usually for several years. Clinical pharmacology lists mercaptopurine as a recommended off-label use for the treatment of Chrons diease and ulcerative colitis. Micromedex lists mercaptopurine as a recommendation Class IIb for both Chrons desiease and ulcerative colitis.
    • The use of mercaptopurine for Non-Hodgkins lymphoma  Lymphoblastic lymphoma has an National Comprehensive Cancer Network (NCCN) compendium category rating of 2A.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    mercaptopurine (PurinetholR)

    1.5 to 2.5mg/kg (50 to 75 mg/m2) PO QD

    Dose should be adjusted to maintain an absolute neutrophil count (ANC) at a desirable level.

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

    PurixanTM

    1.5 to 2.5mg/kg (50 to 75 mg/m2) PO QD

    Length of Benefit

  7. Product Availability:
    Oral suspension: 2000 mg/100 mL (20 mg/mL)
  8. References:
    1. Purixan [Prescribing Information] Leicester, UK: Nova Laboratories Ltd; December 2014.
    2. Mercaptopurine. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 26, 2015.
    3. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. June 26, 2015.
    4. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com. Accessed June 26, 2015.
    5. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 25, 2015.
    6. National Comprehensive Cancer Network. Acute Lymphoblastic Leukemia Version 1.2015.  Available at: http://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed June 26, 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.