HELP PATIENTS GET ACCESS TO KRYSTEXXA

Get forms and information to send to payers, as well as codes you may need to complete the coding and reimbursement process for KRYSTEXXA.

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KRYSTEXXAConnect OFFERS ACCESS TO PATIENT ASSISTANCE PROGRAMS

Your Patient Access Manager can provide personalized support to you and your patient when evaluating these options.

PATIENT SITUATION MEDICAL COST ASSISTANCE TRAVEL COST ASSISTANCE
COMMERCIALLY INSURED

The Co-Pay Reduction Program helps eligible patients with their KRYSTEXXA medication deductibles, co-insurance, and co-pays, up to $20,000 per calendar year.

Eligible patients will receive either:

A prepaid MasterCard®, reloaded with the co-pay amount every 2 weeks

A check, delivered directly to the office

Travel reimbursement helps eligible patients with any travel costs for infusion or sUA test appointments.

Assistance is available through independent foundation support. Please contact KRYSTEXXAConnect (1-888-KRYSTEXXA) or your Patient Access Manager.*

UNINSURED

The Patient Assistance Program helps provide eligible patients with access to KRYSTEXXA at no cost (KRYSTEXXA medication only). Eligibility is based on insurance status, income, and US residency.

INSURED, BUT NOT ELIGIBLE FOR THE CO-PAY REDUCTION PROGRAM

If additional financial assistance is needed, independent foundation support may be available. Please contact KRYSTEXXAConnect (1-888-KRYSTEXXA) or your Patient Access Manager for more information.*

Patient situation COMMERCIALLY INSURED
Medical cost assistance

The Co-Pay Reduction Program helps eligible patients with their KRYSTEXXA medication deductibles, co-insurance, and co-pays, up to $20,000 per calendar year.

Eligible patients will receive either:

A prepaid MasterCard®, reloaded with the co-pay amount every 2 weeks

A check, delivered directly to the office

Travel Cost Assistance

Travel reimbursement helps eligible patients with any travel costs for infusion or sUA test appointments.

Assistance is available through independent foundation support. Please contact KRYSTEXXAConnect (1-888-KRYSTEXXA) or your Patient Access Manager.*

Patient situation UNINSURED
Medical cost assistance

The Patient Assistance Program helps provide eligible patients with access to KRYSTEXXA at no cost (KRYSTEXXA medication only). Eligibility is based on insurance status, income, and US residency.

Travel Cost Assistance

Travel reimbursement helps eligible patients with any travel costs for infusion or sUA test appointments.

Assistance is available through independent foundation support. Please contact KRYSTEXXAConnect (1-888-KRYSTEXXA) or your Patient Access Manager.*

Patient situation INSURED, BUT NOT ELIGIBLE FOR THE CO-PAY REDUCTION PROGRAM
Medical cost assistance

If additional financial assistance is needed, independent foundation support may be available. Please contact KRYSTEXXAConnect (1-888-KRYSTEXXA) or your Patient Access Manager for more information.*

Travel Cost Assistance

Travel reimbursement helps eligible patients with any travel costs for infusion or sUA test appointments.

Assistance is available through independent foundation support. Please contact KRYSTEXXAConnect (1-888-KRYSTEXXA) or your Patient Access Manager.*

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

COMMON PRIOR AUTHORIZATION CRITERIA

Although requirements vary by plan, below are the common criteria that may be requested for KRYSTEXXA. For payer-specific criteria, please contact your Patient Access Manager or KRYSTEXXAConnect (1-888-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 Reimbursement Guide and Resource Kit. If you do not have a kit, contact your Patient Access Manager

    Code for chronic gout due to renal impairment should only be used as a secondary diagnosis code

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PLANS MAY REQUIRE ADDITIONAL NOTES ON INSUFFICIENT EFFICACY OR TOLERABILITY

Dates, dosage, 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

Reference American College of Rheumatology (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. If you do not have a kit, contact your Patient Access Manager

IMPORTANT LIMITATIONS OF USE

KRYSTEXXA is not indicated for the treatment of asymptomatic hyperuricemia1

sUA levels in ACR Guidelines

The 2012 American College of Rheumatology Guidelines recommend lowering sUA level to a minimum of <6 mg/dL. Moreover, the ACR recommends lowering the sUA level sufficiently to durably improve the signs and symptoms of gout, which may require a therapeutic sUA level of <5 mg/dL.2

SOLUBILITY OF URIC ACID: LOWERING sUA LEVEL IS NECESSARY TO BEGIN DEPLETION OF URATE BURDEN2-5

sUA LEVEL (mg/dL)

IMPACT ON URATE BURDEN

6.0-6.8

Slows progression of gout; urate burden remains essentially unchanged

4.1-5.9

Begins to slowly dissolve visible and nonvisible tophi

0-4.0

Potential to resolve tophi and reduce the urate burden faster

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Review full ACR Guidelines

Visit the American College of Rheumatology website to download the 2012 Guidelines for Management of Gout.

GET THE GUIDELINES

REIMBURSEMENT FORMS & DOWNLOADS

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ICD-10 Basics for Payers

Review and keep in mind the ICD-10 transition guidelines for payers during the reimbursement process for KRYSTEXXA.

DOWNLOAD GUIDE
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KRYSTEXXAConnect Enrollment Form

Enroll in KRYSTEXXAConnect to get reimbursement support from your Patient Access Manager.

DOWNLOAD FORM
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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
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Coding at a Glance

Get codes you may need to complete the billing and reimbursement process for KRYSTEXXA.

DOWNLOAD CODES
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Important Telephone Numbers

Get the phone numbers for specialty and wholesale distributers of KRYSTEXXA, and whom to call for additional information.

DOWNLOAD NUMBERS
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Alternate Site of Care Letter – Template

Download the following resource to recommend infusion of KRYSTEXXA. This template is a suggestion and should be printed on the physician’s letterhead. The physician is responsible for completing this letter in a way that completely and accurately represents a patient’s circumstances.

DOWNLOAD LETTER DOWNLOAD INSTRUCTIONS

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

Full Prescribing Information
References
  1. KRYSTEXXA [prescribing information]. Horizon Pharma Rheumatology LLC.
  2. Khanna D, et al. 2012 Arthritis Care Res (Hoboken). 2012;64(10):1431-1446.
  3. Perez-Ruiz F. Rheumatology (Oxford). 2009;48(suppl 2):ii9–ii14.
  4. Araujo EG, et al. RMD Open. 2015;1(1):e000075.
  5. Schumacher HR, et al. Arthritis Rheum. 2008;59(11):1540-1548.
For U.S. Healthcare Professionals  |  Patient Site

Indications and Usage

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.

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

Important Safety Information

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: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

INDICATIONS AND USAGE

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.

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

IMPORTANT SAFETY INFORMATION

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.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. 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 studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.

INDICATIONS AND USAGE

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.

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

IMPORTANT SAFETY INFORMATION

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.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. 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 studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.