AUTHORIZATION Horizon Can Help Support Patients at Every Step of the Access Process

KRYSTEXXA® (pegloticase) treatment may require initial action from the HCP and office staff for patients to get access.

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How Does the Access Process Work?

Benefits Investigation

Horizon By Your Side Can Assist You With the Benefits Investigation (BI) Process

Our team will contact your patient’s insurance company to review coverage and work with the patient to ensure they understand:

  • Whether the medicine is covered by their policy
  • Any estimated out-of-pocket costs and financial assistance that may be available
  • All PA requirements

See what you can expect from a Summary of Benefits form

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Prior Authorization

Your Patient May Need a Prior Authorization (PA) Before Beginning Treatment With KRYSTEXXA

Health plans sometimes require a PA before approving coverage of medicine. Also referred to as a preauthorization or precertification, this is a process that your office must complete, describing the reasons your patient should be prescribed KRYSTEXXA® (pegloticase) and why the health plan should cover the costs. PAs are commonly required for medicines that treat rare diseases.

The requirements for a PA will differ between health plans. Your office must complete and submit all required forms and provide other information and documents requested.

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Some of the items commonly required for a PA are:

  • A letter of medical necessity (Downloadable sample below)
  • Health plan identification numbers
  • Confirmation of diagnosis, including test results
  • Your patient’s medical history, including previously tried and failed medications and lifestyle modifications
  • Medical articles about the disease and the Horizon medicine being prescribed
  • Plan-specific PA forms (when applicable)
Common prior authorization criteria image Common prior authorization criteria image

Learn more about what information may be required for KRYSTEXXA patients

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Sample Letters of Medical Necessity image Sample Letters of Medical Necessity image

Use the following resource to request insurance coverage for patients on KRYSTEXXA

Download PDF

Appeal

If a PA Is Denied, an Appeal Can Be Submitted

An appeal letter may be needed if a PA for KRYSTEXXA is denied. When writing an appeal letter, ensure that you address the specific details of the denial reason(s). Refer to the letter of denial for specific language regarding the reason, and address any patient-specific concerns.

Supplemental documentation may include:

  • A letter of medical necessity
  • Relevant clinical notes for your patient
  • Recent test results
  • Your patient’s medical history, including previously tried and failed medications and lifestyle modifications
  • Supporting scientific publications/journal articles
  • A summary of your recommendation at the end of the letter

Make sure you match the exact language in the denial letter. It is imperative to address the specifics of the denial in the appeal. Before you submit your appeal, be sure to:

  • Check for any incomplete or missing information, a common reason for denial
  • Schedule a peer-to-peer meeting with health plan stated guidelines
  • Contact a Patient Access Liaison (PAL) to learn about additional resources and next steps in the process

See how Horizon By Your Side can help with billing and coding

Billing and Coding

Familiarize yourself with important forms and downloadable resources that explain the process

Forms and Downloads
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Patient Enrollment Form

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Learn more about patient enrollment

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.

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.

Please see Full Prescribing Information, including Boxed Warning.

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.

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.

Please see Full Prescribing Information, including Boxed Warning.