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

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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 BKEMV 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.

Remember that your PAL can help you learn more about your insurance coverage criteria

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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 for BKEMV may seem confusing at first. However, your PAL can help you make sense of the process. 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 BKEMV.
  • Estimate of your potential out-of-pocket costs and help with understanding possible cost assistance options.
  • Whether your doctor needs to submit a prior authorization.

Your PAL can stay in touch with you throughout the process and update you 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 physician to see if additional information is needed for the prior authorization process.

Enroll to get PAL assistance with the approval process

How to Enroll

Your PAL can stay in touch with you throughout the process and update you 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 physician to see if 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 an Amgen Rare Disease 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, Amgen 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 an Amgen Rare Disease 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, an Amgen 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 Amgen Rare Disease 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 Amgen By Your Side Team can educate you and your doctor about the process.

Narrator: Throughout the process, the Amgen 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 Amgen By Your Side, visit Amgenbyyourside.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 BKEMV

Learn about Amgen By Your Side financial support programs

APPROVED USE

BKEMV is a prescription medicine used to treat:

  • people with paroxysmal nocturnal hemoglobinuria (PNH).
  • people with atypical hemolytic uremic syndrome (aHUS).

BKEMV is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

  • adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

It is not known if BKEMV is safe and effective in children with PNH or gMG.

IMPORTANT SAFETY INFORMATION

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

BKEMV is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.

  • BKEMV increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria that may quickly become life-threatening or cause death if not recognized and treated early.
    • You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of BKEMV.
    • If you have not been vaccinated and BKEMV must be started right away, you should receive the required vaccine(s) as soon as possible.
    • If you have not been vaccinated and BKEMV must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
    • If you had a meningococcal vaccine in the past, you might need additional vaccines before starting BKEMV. Your healthcare provider will decide if you need additional meningococcal vaccines.
    • Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or eyes sensitive to light.

Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last dose of BKEMV. Your risk of meningococcal infection may continue for several weeks after your last dose of BKEMV. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

BKEMV is only available through a program called the BKEMV Risk Evaluation and Mitigation Strategy (REMS). Before you can receive BKEMV, your healthcare provider must:

  • enroll in the REMS program
  • counsel you about the risk of serious meningococcal infections
  • give you information about the signs and symptoms of serious meningococcal infection
  • make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start BKEMV right away and you are not up to date on your vaccines
  • give you a Patient Safety Card about your risk of meningococcal infection.

BKEMV may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.

  • If your child is treated with BKEMV, your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
  • Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.
  • Certain fungal infections (Aspergillus) may occur if you take BKEMV and have a weak immune system or a low white blood cell count.

Who should not receive BKEMV?

Do not receive BKEMV if you have a serious meningococcal infection when you are starting BKEMV.

Before you receive BKEMV, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if BKEMV will harm your unborn baby or if it passes into your breast milk.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. BKEMV and other medicines can affect each other causing side effects. Know the medications you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of BKEMV?

BKEMV can cause serious side effects, including serious infusion-related reactions. Tell your healthcare provider or nurse right away if you get any of these symptoms during your BKEMV infusion: headache, back pain, diarrhea, upper respiratory infection, urinary tract infections, fever, pain in your abdomen, pain or swelling of your nose or throat, common cold, cough, nausea, vomiting, chest pain, high blood pressure, low red blood cell count, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, swelling of legs or feet, muscle and joint pain, and feeling faint or passing out. If you have an infusion-related reaction to BKEMV, your healthcare provider may need to infuse BKEMV more slowly, or stop BKEMV.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of BKEMV. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for BKEMV.

APPROVED USE

BKEMV is a prescription medicine used to treat:

  • people with paroxysmal nocturnal hemoglobinuria (PNH).
  • people with atypical hemolytic uremic syndrome (aHUS).

BKEMV is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

  • adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

It is not known if BKEMV is safe and effective in children with PNH or gMG.

IMPORTANT SAFETY INFORMATION

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

BKEMV is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.

  • BKEMV increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria that may quickly become life-threatening or cause death if not recognized and treated early.
    • You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of BKEMV.
    • If you have not been vaccinated and BKEMV must be started right away, you should receive the required vaccine(s) as soon as possible.
    • If you have not been vaccinated and BKEMV must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
    • If you had a meningococcal vaccine in the past, you might need additional vaccines before starting BKEMV. Your healthcare provider will decide if you need additional meningococcal vaccines.
    • Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or eyes sensitive to light.

Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last dose of BKEMV. Your risk of meningococcal infection may continue for several weeks after your last dose of BKEMV. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

BKEMV is only available through a program called the BKEMV Risk Evaluation and Mitigation Strategy (REMS). Before you can receive BKEMV, your healthcare provider must:

  • enroll in the REMS program
  • counsel you about the risk of serious meningococcal infections
  • give you information about the signs and symptoms of serious meningococcal infection
  • make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start BKEMV right away and you are not up to date on your vaccines
  • give you a Patient Safety Card about your risk of meningococcal infection.

BKEMV may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.

  • If your child is treated with BKEMV, your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
  • Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.
  • Certain fungal infections (Aspergillus) may occur if you take BKEMV and have a weak immune system or a low white blood cell count.

Who should not receive BKEMV?

Do not receive BKEMV if you have a serious meningococcal infection when you are starting BKEMV.

Before you receive BKEMV, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if BKEMV will harm your unborn baby or if it passes into your breast milk.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. BKEMV and other medicines can affect each other causing side effects. Know the medications you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of BKEMV?

BKEMV can cause serious side effects, including serious infusion-related reactions. Tell your healthcare provider or nurse right away if you get any of these symptoms during your BKEMV infusion: headache, back pain, diarrhea, upper respiratory infection, urinary tract infections, fever, pain in your abdomen, pain or swelling of your nose or throat, common cold, cough, nausea, vomiting, chest pain, high blood pressure, low red blood cell count, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, swelling of legs or feet, muscle and joint pain, and feeling faint or passing out. If you have an infusion-related reaction to BKEMV, your healthcare provider may need to infuse BKEMV more slowly, or stop BKEMV.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of BKEMV. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for BKEMV.