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

Indication

BKEMV™ (eculizumab-aeeb) is indicated for:

  • The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use: BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.

Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, BKEMV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS.

Contraindications: BKEMV is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.

Other Infections

Use caution when administering BKEMV to patients with any other systemic infection. Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with eculizumab products may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving eculizumab products are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Monitoring Disease Manifestations after BKEMV Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing BKEMV for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing BKEMV, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis.

In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during BKEMV treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during BKEMV treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during BKEMV treatment.

If TMA complications occur after BKEMV discontinuation, consider reinstitution of BKEMV treatment, plasma therapy, or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during eculizumab products treatment has not been established. Therefore, treatment with eculizumab products should not alter anticoagulant management.

Infusion-Related Reactions

Administration of eculizumab products may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion-related reaction which required discontinuation of eculizumab. Interrupt BKEMV infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea. The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.

Indication

BKEMV™ (eculizumab-aeeb) is indicated for:

  • The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use: BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.

Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, BKEMV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS.

Contraindications: BKEMV is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.

Other Infections

Use caution when administering BKEMV to patients with any other systemic infection. Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with eculizumab products may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving eculizumab products are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Monitoring Disease Manifestations after BKEMV Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing BKEMV for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing BKEMV, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis.

In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during BKEMV treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during BKEMV treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during BKEMV treatment.

If TMA complications occur after BKEMV discontinuation, consider reinstitution of BKEMV treatment, plasma therapy, or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during eculizumab products treatment has not been established. Therefore, treatment with eculizumab products should not alter anticoagulant management.

Infusion-Related Reactions

Administration of eculizumab products may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion-related reaction which required discontinuation of eculizumab. Interrupt BKEMV infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea. The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.