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Prior Authorization Protocol

ZURAMPICR (lesinurand)


NATL

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

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:
    • Zurampic is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of hyperuricemia associated with gout

    AND

    • Failure or clinically significant adverse effects to of allopurinol or Uloric

    AND

    • Used as combination therapy with allopurinol or Uloric
  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:
    • Black Box Warning: Risk of acute renal failure, more common when used without a xanthine oxidase inhibitor (allopurinol or Uloric). Acute renal failure has occurred with Zurampic and was more common when Zurampic was given alone.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    probenacid

    Hyperuricemia - Initial:
    250 mg PO BID for 1 week

    Hyperuricemia - Prophylaxis:
    500 mg PO BID; if symptoms persist or 24 hour urate excretion below 700 mg, may incrementally increase by 500 mg every 4 weeks as tolerated

    Maximum dose 2000 mg/day

    allopurinol

    Gout: (mild)
    100 to 300 mg/day as a single or divided dose (2-3 times daily)

    Gout: (moderate to severe)
    400 to 600 mg/day as a single or divided dose (2-3 times daily)

    Maximum dose 800 mg/day

    colchicine

    Prophylaxis - less than 1 acute attack/yr
    0.5-0.6 mg/day 3-4 times/wk

    Prophylaxis - more than 1 acute attack/yr
    0.5-0.6 mg/daily up to 1.5-1.8 mg/day

    Maximum dose in patients without risk factors for colchicine toxicity (e.g., elderly, renal or hepatic impairment, weight < 50 kg):
    6 mg/day
    Maximum dose in patients with risk factors: 3 mg/day

    Uloric*

    40 mg PO QD; may be increased to 80 mg QD if serum uric acid levels are not less than 6 mg/dL after 2 weeks

    This section intentionally left blank.

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

    Zurampic (lesinurad)

    Hyperuricemia associated with gout
    200 mg PO QD in combination with a xanthine oxidase inhibitor

    Length of benefit

  7. Product Availability:

    Tablet: 200 mg

  8. References:

    1. Zurampic [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2015.
    2. Micromedex. Thomson Micromedex website. Available at http://0www.micromedexsolutions.com.catalog.llu.edu/micromedex2/librarian/ND_T/evidencexpert/ND_
    PR/evidencexpert/CS/C3EB8B/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/7464AE/ND_PG/evidencexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.GoToDashboard?docId=929283&contentSetId=100&title=Febuxostat&servicesTitle=Febuxostat&brandName=Uloric     . Accessed January 7, 2016.
    3. Clinical Pharmacology. Gold standard, An Elsevier Company. Available at http://www.clinicalpharmacology-ip.com/Forms/drugoptions.aspx?cpnum=509&aprid=7941 Accessed January 7, 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.
Draft Prepared: 19-JAN-16 GR
Approved By Health Net National P&T:
Revised: 15-APR-16 RO