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Prior Authorization Protocol
KRYSTEXXATM (pegloticase)

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 chronic gout in adult patients refractory to conventional therapy.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of symptomatic gout
    AND
    • Failure or clinically significant adverse effects to at least 3 months of allopurinol AND UloricR at the maximum medically appropriate dose
  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:
    • Symptomatic gout includes patients with: baseline serum uric acid (SUA) of at least 8 mg/dL; at least 3 gout flares in the previous 18 months; the presence of at least 1 gout tophus; or gouty arthritis.
    • Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors (e.g. allopurinol) at the maximum medically appropriate dose or for whom these drugs are contraindicated.
    • In clinical trials, patients who received Krystexxa every 4 weeks had a greater incidence of anaphylaxis and infusion reactions as compared to those who received the infusion every 2 weeks.
    • During pre-marketing controlled clinical trials, infusion reactions were reported in 26% of patients treated with 8 mg every 2 weeks and anaphylaxis was reported with a frequency of 6.5% of patients treated every 2 weeks.
    • Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
    • Krystexxa has a Risk Evaluation and Mitigation Strategy (REMS) program that consists of a Medication Guide, a Dear Healthcare Professional Letter, and a Dear Infusion Site Medical Personnel (DISMP) Letter. Patient and physician enrollment in the manufacturer's REMS program is not required.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    allopurinol (AloprimR/ ZyloprimR)
    Gout (mild)
    100 to 300 mg/day PO as a single or
    divided dose (2-3 time daily)
    Gout (moderate to severe)
    400 to 600 mg/day PO as a single or
    divided dose (2-3 times daily)

    800 mg /day

    colchicine (ColcrysR)

    Gout flare - Treatment
    1.2 mg PO at the first sign of flare
    followed by 0.6 mg one hour later
    Gout flare - Prophylaxis
    0.6 mg PO QD to BID
    Treatment - 1.8 mg over 1 hour
    Prophylaxis - 1.2 mg/day

    Maximum dose in patients with
    risk factors for colchicine toxicity
    (e.g. elderly, renal or hepatic impairment, weight < 50 kg):
    Severe renal impairment (< 30 ml/min CrCl) and
    hepatic impairment: do not repeat course
    more than once every 2 weeks

    UloricR (febuxostat) *

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

    Specific maximum dosage
    information is not available;
    doses of up to 120 mg PO daily
    have been used in clinical trials

    probenecid (BenurylTM)

    Hyperuricemia - Initial
    250 mg PO BID for 1 week
    Hyperuricemia - Prophylaxis
    500 mg PO BID;
    if symptoms persist or 24 hour urate excretion is below 700 mg, may incrementally increase by 500 mg every 4 weeks as tolerated
    2000 mg/day
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    Krystexxa
    8 mg IV over 2 hours every 2 weeks

    Before receiving each Krystexxa dose,
    patients should be pre-medicated with
    an oral antihistamine, IV corticosteroid,
    and acetaminophen.

    Patients should also receive prophylaxis for
    gout flares with an NSAID and/or colchicines
    starting 1 week prior to initiating therapy unless
    not tolerated or otherwise contraindicated.

    Serum uric acid levels should be
    monitored before each infusion.

    Krystexxa should be diluted and only be administered
    by intravenous infusion over no less than
    120 minutes via gravity feed, syringe-type pump,
    or infusion pump.

    Krystexxa should be administered in a healthcare setting
    by healthcare providers prepared to manage anaphylaxis.

    6 months or renewal date, whichever is longer

  7. Product Availability:
    Intravenous Solution: 8 mg/1 mL single-use vial
  8. References:
    1. Krystexxa [Prescribing Information] East Brunswick, NJ:Savient Pharmaceuticals, Inc; April 2012.
    2. Clinical Pharmacology Web Site.Available at: http://www.clinicalpharmacology-ip.com/. Accessed May 26, 2015.
    3. Food and Drug Administration. Label and Approval History: Krystexxa. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory. U.S. Department of Health and Human Services. Accessed May 26, 2015.
    4. Food and Drug Administration Center for Drug Evaluation & Research. Briefing Document for the Arthritis Advisory Committee Meeting: Krystexxa/Pegloticase BLA 125293. U.S. Department of Health & Human Services. Published June 16, 2009.
    5. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 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.