Download forms and clinical resources

Reimbursement

Patient Enrollment Form

Choose 1 of 2 convenient options to initiate and complete the Patient Enrollment Form (PEF).

DocuSign® eSignature Patient Enrollment Form

Begin the form and send to your patient over email to complete via DocuSign®.

Begin Here

Downloadable Patient Enrollment Form

Print, complete with your patient, and fax the form to 877-633-9522 OR email it to GoutHBYS@horizontherapeutics.com.

Coding at a Glance

Get codes for the billing and reimbursement process for KRYSTEXXA. Correct coding is the responsibility of the provider submitting the claim.


Common Prior Authorization Criteria

Download the common criteria that may be requested by payors for prior authorization of KRYSTEXXA.


ICD-10 Basics for Payors

Download the ICD-10 transition guidelines for payors during the reimbursement process for KRYSTEXXA.


Sample Letter of Medical Necessity

Consider this sample letter of medical necessity when requesting insurance coverage for KRYSTEXXA. The final letter should completely and accurately represent a patient’s circumstances and be printed on the physician's letterhead.


Sample Summary of Benefits

View a sample of a Summary of Benefits notification.


Important Contact Information

Get the contact information for specialty and wholesale distributors of KRYSTEXXA, and whom to call for additional information.


Horizon By Your Side Overview

A program providing patients non-medical logistical support once prescribed KRYSTEXXA.


Billing and Coding Guide

Download this step-by-step guide to coverage determination, claim submission, and reimbursement.


Providers are responsible for timely and accurate submission of prior authorization requests. Horizon does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

Infusion

Preinfusion Medications

See which medications your patients should take prior to infusing KRYSTEXXA.


Infusion Checklist

Make sure you perform every step of the infusion process for KRYSTEXXA by downloading the Infusion Checklist.


KRYSTEXXA Monitoring Protocol

Use these guidelines to help avoid infusion reactions and anaphylaxis.


Screening for G6PD Deficiency

Learn about the importance of screening for G6PD deficiency prior to the first infusion of KRYSTEXXA.

Site of Care

Infusion Protocol

Download and complete this infusion protocol template to give preinfusion medication and infusion instructions to a site of care.


Site of Care Access Guide

View key considerations for patient access, coordination of care with a prescribing office, and reimbursement.

Patient Resources

Getting Started Video

This educational video tells the complete KRYSTEXXA story, helping appropriate patients understand how gout becomes uncontrolled and how KRYSTEXXA can help.


Getting Started Video Handout

Share the Getting Started Video with your KRYSTEXXA appropriate patients.


Context of Diet Digital Brochure

Provide this information to patients to help clarify the role of diet as it relates to gout.

Patient Support

Horizon By Your Side provides patients with personalized non-medical support once they are prescribed KRYSTEXXA.

Starting KRYSTEXXA

There are several steps that will help prepare patients for infusion and ensure proper administration of KRYSTEXXA.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

  • 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. Delayed hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
  • Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
  • Screen patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency.

CONTRAINDICATIONS:

  • In patients with G6PD deficiency.
  • In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.

WARNINGS AND PRECAUTIONS

Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal 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 the pre-marketing placebo-controlled clinical trials experienced exacerbation. Exercise caution in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥5%) are:

KRYSTEXXA co-administration with methotrexate trial:

KRYSTEXXA with methotrexate: gout flares, arthralgia, COVID-19, nausea, and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reaction, pain in extremity, hypertension, and vomiting.

KRYSTEXXA pre-marketing placebo-controlled trials:

gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

INDICATION

KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult 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.

Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Please see Full Prescribing Information, including Boxed Warning.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

  • 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. Delayed hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
  • Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
  • Screen patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency.

CONTRAINDICATIONS:

  • In patients with G6PD deficiency.
  • In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.

WARNINGS AND PRECAUTIONS

Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal 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 the pre-marketing placebo-controlled clinical trials experienced exacerbation. Exercise caution in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥5%) are:

KRYSTEXXA co-administration with methotrexate trial:

KRYSTEXXA with methotrexate: gout flares, arthralgia, COVID-19, nausea, and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reaction, pain in extremity, hypertension, and vomiting.

KRYSTEXXA pre-marketing placebo-controlled trials:

gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

INDICATION

KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult 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.

Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Please see Full Prescribing Information, including Boxed Warning.