Stay informed for your
patients and practice.

The benefits of KRYSTEXXA are available for most patients
A variety of support and financial programs are available at no cost to your patients

~93%

of commercial lives after appropriate ULT trial

99%

of Medicare Advantage lives after appropriate ULT trial

100%

of Medicare Fee-For-Service lives*

$0 CO-PAY

for eligible commercially insured patients

See Terms and Conditions

*There are no national or local coverage determinations for KRYSTEXXA.

ULT, urate-lowering therapy.

PATIENT SITUATION MEDICAL COST ASSISTANCE
COMMERCIALLY
INSURED

Patients with commercial insurance may be eligible for a $0 co-pay for both the cost of the medication and the infusion administration through our Amgen Commercial Co-Pay Program.†
UNINSURED

If your patient does not have insurance and needs KRYSTEXXA, please contact Amgen By Your Side. Our team is diligent in exploring all options to help your patient.
INSURED, BUT NOT
ELIGIBLE FOR THE
CO-PAY PROGRAM

If additional financial assistance is needed, independent foundation support may be available. Please contact Amgen By Your Side (877-633-9521) for more information.‡

If additional financial assistance is needed, independent foundation support may be available. Please contact Amgen By Your Side (877-633-9521) for more information.‡
  • Patient’s prescription cannot be paid in part or in full by any government-funded program including but not limited to: Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, Department of Defense (DOD), TRICARE, or any state, patient foundation, or other pharmaceutical program
  • Patient is prescribed a covered Amgen rare disease medication for an indication approved by the Food and Drug Administration; the indication for each product is shown in its prescribing information
  • Patient is a resident of the United States
  • Patient must be commercially insured and have financial responsibility for a portion of the drug and/or infusion cost if applicable

The assistance offered under this co-pay program is subject to additional terms and conditions, including but not limited to the following:

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 any government-funded program including but not limited to Medicare, Medicare Part D, Medicaid, Medigap, VA, CHAMPUS, DOD, TRICARE, or any state, patient foundation, or other pharmaceutical program. Offer good only in the United States at participating specialty pharmacies or sites of care. Offer not valid where otherwise prohibited by law, for example by applicable state law prohibiting co-pay cards. Amgen reserves the right to rescind, revoke, or amend offer without notice. The selling, purchasing, trading, or counterfeiting of any co-pay card or benefits is prohibited by law. This co-pay program is not insurance and is not intended to substitute for insurance. Age for eligibility is dependent on product indication.

Participating Pharmacies or Healthcare Providers: By using this co-pay program, you acknowledge and confirm that the prescription will not be reimbursed in whole or in part by any government-funded program (such as, without limitation, Medicare, Medicaid, VA, DOD, TRICARE) and the patient and prescription meet the eligibility criteria set forth in the terms and conditions. You are responsible for reporting the receipt of the co-pay program benefits as required by an insurer, payor, or applicable law or regulation.

Patients: By enrolling in this co-pay program, you acknowledge and confirm that you and the prescription meet the eligibility requirements set forth in the terms and conditions, including that the prescription will not be reimbursed in whole or in part by any government-funded program (such as, without limitation, Medicare, Medicaid, VA, DOD, TRICARE). You may not seek any claims to government payors or other payors or insurers for this prescription. You may not seek reimbursement from any health savings, flexible savings, or other healthcare reimbursement account for any amounts received from the co-pay program. You are responsible for reporting the receipt of the co-pay program benefits as required by an insurer, payor, or applicable law or regulation.

‡Please note that independent foundations establish, administer, and implement the funds, which are separate and apart from Amgen.

Authorize criteria icon Authorize criteria icon
Authorize criteria icon

Common prior authorization criteria

Although requirements vary by plan, below are the common criteria that may be requested for KRYSTEXXA.

Patient is covered by approved product label

  1. Date of birth (adult patients only)
  2. Lab results: G6PD (normal activity only)
  3. Appropriate chronic gout diagnosis code
    • Use the coding wheel in the Treatment Initiation Kit
    • Code for chronic gout due to renal impairment should only be used as a secondary diagnosis code

    Dates, doses, and duration of treatment with xanthine oxidase inhibitors (allopurinol or febuxostat)

    • Include any medication side effects, if applicable

    Lab results: sUA levels throughout previous treatments

    • ACR Guidelines. See below

    Number of gout flares in the last 18 months and/or number of visible tophi

    • Provide any relevant imaging results
    • If patient has visible tophi, use coding wheel in the Reimbursement Guide and Resource Kit to indicate location

Common Prior Authorization Criteria

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

Download Guide

Review full ACR Guidelines

Visit the American College of Rheumatology website to download the 2020 Guidelines for the Management of Gout.

Get the Guidelines

Reimbursement forms and downloads
Patient Enrollment Form

Once you decide KRYSTEXXA is right for your patient, you can start their enrollment in Amgen By Your Side with the Patient Enrollment Form (PEF) and submit it using one of the options listed below. Patient consent will be required.

Option 1: Online Submission

Fill out the form, sign, and submit online through DocuSign®.

Begin Here

Option 2: Offline Submission

Fill out the form, then download, sign, and fax the form to 877-633-9522 OR email it to GOUTABYS@amgen.com.

Download Form

Download Patient Enrollment Form Guide

All trademarks appearing herein are the property of their respective owners.

ICD-10 Basics for Payors

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

Download Guide

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.

Download Codes

Letter of Medical Necessity Template

Download the following resource to request insurance coverage for KRYSTEXXA for patients. This template should be printed on the physician’s letterhead. The HCP is responsible for completing this letter in a way that completely and accurately represents a patient’s circumstances.

Download Letter
Download Instructions

Important Contact Information

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

Download Contacts
Providers are responsible for timely and accurate submission of prior authorization requests. Amgen does not make any representation or guarantee concerning reimbursement or coverage for any service or item.
Full Prescribing Information

Patient support

Amgen By Your Side provides patients with personalized nonmedical support once they are prescribed KRYSTEXXA.

See Resources

Starting KRYSTEXXA

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

See Step-by-Step Instructions

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.