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... See more

Now Available: KRYSTEXXA Ready-to-Use (RTU) Vial 8 mg/50 mL Learn more
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Introducing the KRYSTEXXA® (pegloticase) READY-TO-USE (RTU) VIAL 8 mg/50 mL

  • Prescribe KRYSTEXXA and experience the same trusted efficacy with the RTU vial1
  • The RTU vial—no IV bags, no saline dilution, and it’s ready for infusion via an infusion pump1
  • To administer the RTU vial over 120 minutes, the appropriate infusion rate is 25 mL per hour1

Prescribe with confidence. Learn how to switch to the RTU vial today.

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  • Reference
    • KRYSTEXXA (pegloticase) [prescribing information] Amgen.

Key Inclusion/Exclusion Criteria2

Inclusion

  • Adult patients ≥18 years old with diagnosis of gout
  • Uncontrolled gout, defined as (all required)
    • Serum uric acid (sUA) ≥7 mg/dL
    • Oral urate-lowering therapy failure/intolerance
    • ≥1 ongoing gout symptom (≥1 tophus, ≥2 flares in the year prior to screening and/or chronic gouty arthritis)

Exclusion

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • eGFR <40 mL/min/1.73 m2
  • MTX contraindication/known intolerance
  • Elevated LFTs, low albumin, or low blood cell counts
eGFR, estimated glomerular filtration rate; LFTs, liver function tests; MTX, methotrexate.

Family history, health literacy, and socioeconomic environment are contributing factors to gout becoming uncontrolled18,19

Two major factors contribute to uric acid buildup and crystallization18,19

Genetics
Gout runs in the family
Kidney damage
Impaired uric acid elimination
Additional contributing factors include4,20:
  • Diet and lifestyle
  • Age
  • Comorbidities
  • Metabolism
Diet is not a substitute for treatment as dietary restrictions may reduce uric acid levels by only ~1 mg/dL9,10

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REIMBURSEMENT CENTER

Help patients gain access to KRYSTEXXA

Get forms and information to send to payors as well as codes you may need to complete the coding and reimbursement process for KRYSTEXXA.
Common prior authorization criteria and other documents
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patients and practice.
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The benefits of KRYSTEXXA are available for most patients

A variety of support and financial programs are available at no cost to your patients
Shield icon

~93%

of commercial lives after appropriate ULT trial
Medicare advantage icon

99%

of Medicare Advantage lives after appropriate ULT trial
Medicare fee-for-services icon

100%

of Medicare Fee-For-Service lives*
Co-pay icon

$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.‡
  • ‡The Amgen Commercial Co-Pay Program may be available to patients who meet the following minimum criteria:
    • 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.

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 Download Form-Spanish
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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

Starting KRYSTEXXA

Learn more about getting your patients with uncontrolled gout started on KRYSTEXXA.

See The Step-by-Step Instructions

Patient support

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

Learn More Here

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. Life threatening hemolytic reactions 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

Anaphylaxis
In a 52-week controlled trial of KRYSTEXXA co-administered with methotrexate (MTX) compared to KRYSTEXXA alone, one patient treated with KRYSTEXXA co-administered with MTX (1%) experienced anaphylaxis during the first infusion and no patients experienced anaphylaxis treated with KRYSTEXXA alone. Patients were pre-treated with infusion reaction prophylaxis and KRYSTEXXA was discontinued following 2 consecutive serum uric acid levels above 6 mg/dL to reduce the risk of anaphylaxis and infusion reactions. These risks are higher in patients whose uric acid level increases to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
During pre-marketing clinical trials with KRYSTEXXA alone, KRYSTEXXA was not discontinued following 2 consecutive serum uric acid levels above 6 mg/dL. Anaphylaxis was reported with 6.5% (8/123) of patients treated with KRYSTEXXA every 2 weeks and 4.8% (6/126) for the every 4-week dosing regimen. There were no cases of anaphylaxis in patients receiving placebo. Anaphylaxis generally occurred within 2 hours after treatment.
Diagnostic criteria of anaphylaxis were skin or mucosal tissue involvement, and, either airway compromise, and/or reduced blood pressure with or without associated symptoms, and a temporal relationship to KRYSTEXXA or placebo injection with no other identifiable cause. Manifestations included wheezing, peri-oral or lingual edema, or hemodynamic instability, with or without rash or urticaria, nausea or vomiting. Cases occurred in patients being pre-treated with one or more doses of an oral antihistamine, an intravenous corticosteroid and/or acetaminophen, which may have resulted in an underestimate of anaphylaxis frequency reported. Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.
It is recommended that before starting KRYSTEXXA patients discontinue oral urate-lowering medications and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

Infusion Reactions
In the 52-week trial, infusion reactions were reported in 4% of patients in the KRYSTEXXA co-administered with MTX group compared to 31% of patients treated with KRYSTEXXA alone. In both treatment groups, the majority of infusion reactions occurred at the first or second KRYSTEXXA infusion and during the time of infusion.
During pre-marketing 24-week controlled clinical trials with KRYSTEXXA alone, infusion reactions were reported in 26% of patients treated with KRYSTEXXA 8 mg every 2 weeks, and 41% of patients treated with KRYSTEXXA 8 mg every 4 weeks, compared to 5% of patients treated with placebo. These infusion reactions occurred in patients being pre-treated with an oral antihistamine, intravenous corticosteroid and/or acetaminophen, which may have resulted in an underestimate of infusion reaction frequency reported.
Manifestations of these reactions included urticaria (10.6%), dyspnea (7.1%), chest discomfort (9.5%), chest pain (9.5%), erythema (9.5%), and pruritus (9.5%). These manifestations overlap with the symptoms of anaphylaxis, but in a given patient did not occur together to satisfy the clinical criteria for diagnosing anaphylaxis. Infusion reactions occurred at any time during a course of treatment with ~3% occurring with the first infusion, and ~91% occurred during the time of infusion.
KRYSTEXXA should be infused slowly over no less than 120 minutes. In the event of an infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Gout Flares:
In the 52-week trial of KRYSTEXXA co-administered with MTX vs KRYSTEXXA alone, patients were administered gout flare prophylaxis, resulting in 66% and 69% of patients with any flare for the first 3 months, respectively. In the KRYSTEXXA co-administered with MTX group, the percentages of patients with any flare for the subsequent 3 month increments of treatment were 27%, 8%, and 9% during Months 6, 9, and 12, respectively; in the group treated with KRYSTEXXA alone, 14%, 9%, and 21% during Months 6, 9, and 12, respectively.
During the 24-week pre-marketing, controlled trials, with KRYSTEXXA alone the frequencies of gout flares were high in all treatment groups, but more so with KRYSTEXXA treatment during the first 3 months, and decreased in the subsequent 3 months. The percentages of patients with any flare for the first 3 months were 74%, 81%, and 51%, for KRYSTEXXA 8 mg every 2 weeks, KRYSTEXXA 8 mg every 4 weeks, and placebo, respectively. The percentages of patients with any flare for the subsequent 3 months were 41%, 57%, and 67%, for KRYSTEXXA 8 mg every 2 weeks, KRYSTEXXA 8 mg every 4 weeks, and placebo, respectively. Patients received gout flare prophylaxis with colchicine and/or NSAIDs starting at least one week before receiving KRYSTEXXA. Gout flares may occur after initiation of KRYSTEXXA. An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Gout flare prophylaxis with a 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. KRYSTEXXA does not need to be discontinued because of a gout flare. The gout flare should be managed concurrently as appropriate for the individual patient.

Congestive Heart Failure (CHF)
KRYSTEXXA has not been formally studied in patients with CHF, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Two cases of CHF exacerbation occurred during the trials in patients receiving treatment with KRYSTEXXA 8 mg every 2 weeks. No cases were reported in placebo-treated patients. Four subjects had exacerbations of pre-existing CHF while receiving KRYSTEXXA 8 mg every 2 weeks during the OLE study. Exercise caution in patients who have congestive heart failure and monitor patients closely following infusion.

Re-treatment with KRYSTEXXA
No controlled trial data are available on re-treatment after stopping treatment for longer than 4 weeks. Due to the immunogenicity of KRYSTEXXA, patients receiving re-treatment may be at increased risk of anaphylaxis and infusion reactions. Therefore, patients receiving re-treatment after a drug-free interval should be monitored carefully.

ADVERSE REACTIONS

The most common adverse reactions (≥5%) are:

Co-administration with MTX:

Gout flares, arthralgia, COVID-19, nausea, and fatigue.

KRYSTEXXA alone:

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.