Co-Pay Reduction

The KRYSTEXXA Connect Co-Pay Reduction Program is designed to help commercially insured eligible patients with their deductible, co-insurance, and/or co-pay requirements for KRYSTEXXA® (pegloticase) Injection, 8 mg/mL, for Intravenous Infusion.

For all KRYSTEXXA infusions during the calendar year, Horizon Pharma plc will reimburse the patient’s combined out-of-pocket co-payment, co-insurance, or deductible amount for a total program benefit up to $15,000 per patient per calendar year.

Terms and Conditions: Offer cannot be combined with any other rebate or coupon, free trial, or similar offer for the specified prescription. Not valid for prescriptions reimbursed in whole or in part by Medicaid, Medicare, VA, DOD, TriCare, or other federal or state programs (including state prescription drug programs). Offer good only in the United States at participating retail pharmacies. Absent a change in Massachusetts law, offer not valid in Massachusetts after July 1, 2017. Offer not valid where otherwise prohibited by law. Horizon Pharma reserves the right to rescind, revoke, or amend offer without notice. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law. This card is not insurance and is not intended to substitute for insurance. Participating patients and pharmacists understand and agree to comply with all Terms and Conditions of offer. Patients must be 18 or older.

Co-Pay/Insurance Verification

  • Reimbursement hotline staff can conduct patient-specific research with insurers to confirm coverage for KRYSTEXXA and its infusion, including coverage requirements and patient benefit level (such as co-payment and out-of-pocket obligation)

Enrollment Form


copay-enrollment-form

IMPORTANT SAFETY INFORMATION

INDICATION

KRYSTEXXA® (pegloticase) is a PEGylated uric acid–specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

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 at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Important Limitations of Use:

KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS
  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Patients should be premedicated with antihistamines and corticosteroids.
  • Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
  • 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.
CONTRAINDICATIONS
  • Glucose-6-phosphate dehydrogenase (G6PD) Deficiency: Before starting KRYSTEXXA, confirm patients are not G6PD deficient. Patients at higher risk for G6PD deficiency (e.g., those of African and Mediterranean ancestry) should be screened because of the risk of hemolysis and methemoglobinemia, however any patient could be affected.
WARNINGS AND PRECAUTIONS
  • Anaphylaxis: Anaphylaxis occurred in patients treated with KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
  • Infusion Reactions: Infusion reactions occurred in patients treated with KRYSTEXXA. KRYSTEXXA should be administered in a healthcare setting and by healthcare providers prepared to manage infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Monitor patients closely for signs and symptoms of infusion reactions. In the event of an infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate. If a severe infusion reaction occurs, discontinue infusion and institute treatment as needed. The risk of an infusion reaction is higher in patients who have lost therapeutic response.
    • 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.
    • Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of serum uric acid levels. It is recommended that patients discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.
  • Gout Flares: An increase in gout flares is frequently observed upon initiation of antihyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. Gout flare prophylaxis with a nonsteroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.
  • Congestive Heart Failure: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure, and monitor patients closely following infusion.
  • Re-treatment: No controlled clinical data is available on the safety and efficacy of re-treatment with KRYSTEXXA after stopping treatment for longer than 4 weeks. Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully.
ADVERSE REACTIONS

The most commonly reported serious adverse reactions in the pivotal trial with the approved regimen of 8 mg KRYSTEXXA administered every 2 weeks were gout flares, infusion reactions, and anaphylaxis. Most common adverse reactions: gout flares (77%), infusion reactions (26%), nausea (12%), contusion or ecchymosis (11%), nasopharyngitis (7%), constipation (6%), chest pain (6%), anaphylaxis (5%), and vomiting (5%). In addition to events occurring in greater than 5%, exacerbation of pre-existing congestive heart failure occurred in 2%.

Please see the Medication Guide and Prescribing Information, including Boxed Warning, for more information.

To report SUSPECTED ADVERSE REACTIONS, contact Horizon Pharma plc at 1-866-479-6742, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.