For Patients and Caregivers For Healthcare Professionals Important Safety Information Medication Guide KRYSTEXXA.com

This information is intended for U.S. healthcare professionals

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UNDERSTANDING INSURANCE AND APPROVAL

We Are Here to Help Navigate the Insurance Process

Amgen By Your Side can guide you throughout the process, keeping you up to date on the status of your insurance review and helping you keep the process moving.

Understanding Insurance

Is KRYSTEXXA Covered by Insurance?

Through our team’s knowledge of how insurance companies work and our understanding of your specific benefits, your Patient Access Liaison (PAL) can help you understand the insurance process by walking you through your coverage and potential financial assistance options.

Once you and your doctor agree on a plan that works best for you, your PAL will talk to you about the insurance approval process and what your potential out-of-pocket treatment costs may be.

Connect with a PAL to learn more about your insurance coverage criteria

Request a PAL
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Download this brochure for additional important information about Amgen By Your Side and the insurance process, including worksheets to help organize important details from your PAL.

You will learn about:

  • Out-of-pocket costs
  • Medication coverage
  • Rules that can affect your coverage
  • Support for people with disabilities
  • How health plans determine coverage and what to consider when choosing a plan

Insurance Approval Process

Insurance Approvals and Amgen By Your Side

The insurance approval process for KRYSTEXXA® (pegloticase) may seem confusing at first. However, your PAL can help you make sense of it. Your insurance review will likely include a Benefits Investigation and Summary of Benefits to go over the following:

  • Details of your insurance coverage criteria for KRYSTEXXA
  • Estimate of your potential out-of-pocket costs to determine the best resource for offsetting treatment-related costs
  • Whether prior authorization is needed from your doctor

Your PAL can stay in touch with you throughout the process and keep you up to date on the status of your insurance review. Additionally, your PAL can help you learn about steps you can take to keep the process moving, including completing any required labs and following up with your doctor to see if any additional information is needed for the prior authorization process.

Connect with a PAL to learn more about your insurance coverage criteria

Request a PAL

Your PAL can stay in touch with you throughout the process and keep you up to date on the status of your insurance review. Additionally, your PAL can help you learn about steps you can take to keep the process moving, including completing any required labs and following up with your doctor to see if any additional information is needed for the prior authorization process.

Learn More About the Insurance Approval Process and How to Understand Your Coverage and Benefits

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Narrator: If you’ve recently been prescribed a Horizon medicine, there are a few steps to the insurance approval process. This will look slightly different for each patient and the time it may take to get approval can vary.

Narrator: Fortunately, Horizon By Your Side, a patient support program designed specifically for you, will be there “by your side” every step of the way, to make the process as smooth as possible.

Narrator: When your health plan decides whether to cover a Horizon medication, their review process may include several steps.

Narrator: First – a benefits investigation. After your doctor prescribes your medicine and you provide permission through a patient consent form, a Horizon By Your Side team member will contact your health plan to review your coverage.

Your Patient Access Liaison, or PAL, or, in some cases, a Clinical Nurse Educator, a CNE will call you with information on the progress of your benefits investigation and review:

Whether the medicine is covered by your policy and prior authorization requirements.

Your estimated out-of-pocket costs and financial assistance that may be available to you.

Narrator: Second – Prior Authorization or “PA”. While often needed, sometimes a “PA” may not be required. If a Prior Authorization IS required for you, this is a process your doctor must complete, describing the reasons you should be prescribed the medicine and why the costs should be covered.

Narrator: Third – Health Plan Decision – After receiving all required information, your health plan will determine whether it will cover your Horizon medicine. You and your doctor’s office should receive a written decision from the health plan.
If your health plan denies coverage, you can work with your doctor’s office to appeal this decision. The Horizon By Your Side Team can educate you and your doctor about the process.

Narrator: Throughout the process, the Horizon By Your Side team will provide support by:

  • Contacting your health plan to review your insurance coverage
  • Providing your doctor with education on any requirements or PA decisions
  • Going over alternative options you may use to access your medicine while the insurance review is underway
  • Staying in touch with you throughout the process to keep you up to date on the status of the review

Narrator: For more information on the insurance approval process and the services available to patients and healthcare providers from Horizon By Your Side, visit horizonbyyourside.com.

The 5-Step Insurance Approval Process

  • Benefits Investigation

    After your doctor prescribes your medicine and you provide permission through a Health Insurance Portability and Accountability Act (HIPAA) release form, an Amgen By Your Side team member will contact your health plan to review your coverage. Some health plans will require you to make this request yourself; a team member from Amgen By Your Side can assist you with making the request. This review, called a benefits investigation, is conducted to learn:

    • Whether the medicine you were prescribed is covered by your policy
    • Your estimated out-of-pocket costs, including deductibles, co-payments, and coinsurance
    • Whether your health plan requires prior authorization (PA) for coverage and the steps for completing it
    • Whether your doctor must request a medical exception, using a letter of medical necessity

    TIP: Your PAL will call you with information on the progress of your benefits investigation.

  • Prior Authorization (PA) and Common Requirements

    Health plans sometimes require a PA before approving coverage of medicine. This is a process that your doctor must complete, describing the reasons you should be prescribed the medicine and why the health plan should cover the costs. A PA is sometimes also referred to as a preauthorization or precertification.

  • Medical Exception

    If your health plan does not cover your Amgen medicine, your doctor can request a medical exception. This is a special request, requiring additional paperwork, explaining why you need treatment with an Amgen medicine.

  • Health Plan Decision

    After receiving all required information, your health plan will determine whether it will cover your Amgen medicine. You and your doctor’s office should receive a written decision from the health plan.

  • Appeal

    If your health plan denies coverage for an Amgen medicine, you can work with your doctor’s office to appeal the decision. The Amgen By Your Side team can educate you and your doctor about this process.

Your PAL can stay in touch with you throughout the process and keep you up to date on the status of your insurance review.

Learn how Amgen By Your Side provides support services for patients on KRYSTEXXA

Learn about Amgen By Your Side cost assistance programs

USE

KRYSTEXXA® (pegloticase) is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.
KRYSTEXXA is not for use in people with too much uric acid in their bodies who do not have symptoms (asymptomatic hyperuricemia).

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about KRYSTEXXA?

Serious allergic reactions may happen in some patients who receive KRYSTEXXA. These allergic reactions can be life-threatening and usually happen within 2 hours of the infusion.

KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated. Your doctor or nurse should watch you for any signs of a serious allergic reaction during and after your treatment with KRYSTEXXA.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with KRYSTEXXA:

  • wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing
  • dizziness, fainting, fast or weak heartbeat or feeling nervous
  • reddening of the face, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Who should not receive KRYSTEXXA?

Do not receive KRYSTEXXA if you:

  • have a rare blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
  • have had a serious allergic reaction to KRYSTEXXA or any of its ingredients. See the end of the Medication Guide for a complete list of ingredients in KRYSTEXXA.

What should I tell my doctor before receiving treatment with KRYSTEXXA?

Before you receive KRYSTEXXA, tell your doctor about all of your medical conditions, including if you:

  • ever had any heart problems or high blood pressure.
  • are pregnant or plan to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk. You and your doctor should decide if you will receive KRYSTEXXA or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not take any other uric acid lowering drug, such as allopurinol, febuxostat (Uloric), or probenecid, while receiving KRYSTEXXA.

KRYSTEXXA is recommended to be given with another prescription medicine called methotrexate.  KRYSTEXXA may also be used alone. You and your doctor will decide the treatment that is right for you.

Prior to your treatment with KRYSTEXXA, your doctor may give you medicine to help reduce your risk of getting gout flares or an allergic reaction. Take these medicines as directed by your doctor or nurse. Your doctor will also test your uric acid levels prior to each treatment to monitor your response to KRYSTEXXA.

Your gout flares may increase in the first 3 months when you start receiving KRYSTEXXA. It’s important to understand that this is happening because KRYSTEXXA is breaking down uric acid in your body. Do not stop receiving KRYSTEXXA even if you have a flare, as the amount of flares will decrease after 3 months of treatment. Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting KRYSTEXXA.

What are the possible side effects of KRYSTEXXA?

In KRYSTEXXA clinical trials:

The most common side effects of KRYSTEXXA when given together with methotrexate were gout flares, joint pain, coronavirus disease 2019 (COVID-19), nausea, and fatigue.

The most common side effects of KRYSTEXXA were gout flares, allergic reactions (including infusion reactions). See “What is the most important information I should know about KRYSTEXXA?”, nausea, bruising, sore throat, constipation, chest pain, coronavirus disease 2019 (COVID-19), and vomiting.

This is not a complete list of all possible side effects. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

For additional important safety information, please see the Medication Guide and discuss with your doctor.

USE

KRYSTEXXA® (pegloticase) is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.
KRYSTEXXA is not for use in people with too much uric acid in their bodies who do not have symptoms (asymptomatic hyperuricemia).

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about KRYSTEXXA?

Serious allergic reactions may happen in some patients who receive KRYSTEXXA. These allergic reactions can be life-threatening and usually happen within 2 hours of the infusion.

KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated. Your doctor or nurse should watch you for any signs of a serious allergic reaction during and after your treatment with KRYSTEXXA.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with KRYSTEXXA:

  • wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing
  • dizziness, fainting, fast or weak heartbeat or feeling nervous
  • reddening of the face, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Who should not receive KRYSTEXXA?

Do not receive KRYSTEXXA if you:

  • have a rare blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
  • have had a serious allergic reaction to KRYSTEXXA or any of its ingredients. See the end of the Medication Guide for a complete list of ingredients in KRYSTEXXA.

What should I tell my doctor before receiving treatment with KRYSTEXXA?

Before you receive KRYSTEXXA, tell your doctor about all of your medical conditions, including if you:

  • ever had any heart problems or high blood pressure.
  • are pregnant or plan to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk. You and your doctor should decide if you will receive KRYSTEXXA or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not take any other uric acid lowering drug, such as allopurinol, febuxostat (Uloric), or probenecid, while receiving KRYSTEXXA.

KRYSTEXXA is recommended to be given with another prescription medicine called methotrexate.  KRYSTEXXA may also be used alone. You and your doctor will decide the treatment that is right for you.

Prior to your treatment with KRYSTEXXA, your doctor may give you medicine to help reduce your risk of getting gout flares or an allergic reaction. Take these medicines as directed by your doctor or nurse. Your doctor will also test your uric acid levels prior to each treatment to monitor your response to KRYSTEXXA.

Your gout flares may increase in the first 3 months when you start receiving KRYSTEXXA. It’s important to understand that this is happening because KRYSTEXXA is breaking down uric acid in your body. Do not stop receiving KRYSTEXXA even if you have a flare, as the amount of flares will decrease after 3 months of treatment. Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting KRYSTEXXA.

What are the possible side effects of KRYSTEXXA?

In KRYSTEXXA clinical trials:

The most common side effects of KRYSTEXXA when given together with methotrexate were gout flares, joint pain, coronavirus disease 2019 (COVID-19), nausea, and fatigue.

The most common side effects of KRYSTEXXA were gout flares, allergic reactions (including infusion reactions). See “What is the most important information I should know about KRYSTEXXA?”, nausea, bruising, sore throat, constipation, chest pain, coronavirus disease 2019 (COVID-19), and vomiting.

This is not a complete list of all possible side effects. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

For additional important safety information, please see the Medication Guide and discuss with your doctor.