For Patients and Caregivers For Healthcare Professionals Important Safety Information Medication Guide ACTIMMUNE.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 ACTIMMUNE Covered by Insurance?

Through our team’s knowledge of how insurance companies work and our understanding of your specific benefits, your Clinical Nurse Educator (CNE) can help you understand the insurance process by walking you through your coverage and possible financial assistance options.

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

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

download brochureinsurance-page

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 CNE.

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 ACTIMMUNE® (Interferon gamma-1b) may seem confusing at first. However, your CNE 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 ACTIMMUNE
  • 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

Don’t forget, your CNE can assist with the approval process

Your CNE can stay in touch with you throughout the process and keep you up to date on the status of your insurance review. Additionally, your CNE 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 for coverage and the steps for completing it
    • Whether your doctor must request a medical exception, using a letter of medical necessity

    TIP: Your CNE 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 (Approval/Denial)

    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 CNE 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 ACTIMMUNE

Learn about Amgen By Your Side cost assistance programs

Important Safety Information

What is ACTIMMUNE® (Interferon gamma-1b) used for?

ACTIMMUNE® is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body’s ability to fight infections effectively. CGD is often treated (though not cured) with antibiotics, antifungals, and ACTIMMUNE.

ACTIMMUNE is also used to slow the worsening of severe, malignant osteopetrosis (SMO). SMO is a genetic disorder that affects normal bone formation and is usually diagnosed in the first few months after birth.

When should I not take ACTIMMUNE?

Don’t use ACTIMMUNE if you are allergic to interferon-gamma, E. coli-derived products, or any ingredients contained in the product.

What warnings should I know about ACTIMMUNE?

At high doses, ACTIMMUNE can cause (flu-like) symptoms, which may worsen some pre-existing heart conditions.

ACTIMMUNE may cause decreased mental status, walking disturbances, and dizziness, particularly at very high doses. These symptoms are usually reversible within a few days upon dose reduction or discontinuation of therapy.

Bone marrow function may be suppressed with ACTIMMUNE, and decreased production of cells important to the body may occur. This effect, which can be severe, is usually reversible when the drug is discontinued or the dose is reduced.

Taking ACTIMMUNE may cause reversible changes to your liver function, particularly in patients less than 1 year old. Your doctor should monitor your liver function every 3 months, and monthly in children under 1 year.

In rare cases, ACTIMMUNE can cause severe allergic reactions and/or rash. If you experience a serious reaction to ACTIMMUNE, discontinue it immediately and contact your doctor or seek medical help.

What should I tell my healthcare provider?

Be sure to tell your doctor about all the medications you are taking.

Tell your doctor if you:

  • are pregnant or plan to become pregnant or plan to nurse
  • have a cardiac condition such as irregular heartbeat, heart failure, or decreased blood flow to your heart
  • have a history of seizures or other neurologic disorders
  • have, or have had, reduced bone marrow function. Your doctor will monitor these cells with blood tests at the beginning of therapy and at 3-month intervals on ACTIMMUNE therapy

What are the side effects of ACTIMMUNE?

The most common side effects with ACTIMMUNE are “flu-like” symptoms such as fever, headache, chills, muscle pain, or fatigue, which may decrease in severity as treatment continues. Bedtime administration of ACTIMMUNE may help reduce some of these symptoms. Acetaminophen may be helpful in preventing fever and headache.

What other medications might interact with ACTIMMUNE?

Some drugs may interact with ACTIMMUNE to potentially increase the risk of damage to your heart or nervous system, such as certain chemotherapy drugs. Tell your doctor about all other medications you are taking.

Avoid taking ACTIMMUNE at the same time as a vaccination.

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

The risk information provided here is not comprehensive. To learn more, talk about ACTIMMUNE with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at http://www.ACTIMMUNE.com or 1-866-479-6742.

Important Safety Information

What is ACTIMMUNE® (Interferon gamma-1b) used for?

ACTIMMUNE® is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body’s ability to fight infections effectively. CGD is often treated (though not cured) with antibiotics, antifungals, and ACTIMMUNE.

ACTIMMUNE is also used to slow the worsening of severe, malignant osteopetrosis (SMO). SMO is a genetic disorder that affects normal bone formation and is usually diagnosed in the first few months after birth.

When should I not take ACTIMMUNE?

Don’t use ACTIMMUNE if you are allergic to interferon-gamma, E. coli-derived products, or any ingredients contained in the product.

What warnings should I know about ACTIMMUNE?

At high doses, ACTIMMUNE can cause (flu-like) symptoms, which may worsen some pre-existing heart conditions.

ACTIMMUNE may cause decreased mental status, walking disturbances, and dizziness, particularly at very high doses. These symptoms are usually reversible within a few days upon dose reduction or discontinuation of therapy.

Bone marrow function may be suppressed with ACTIMMUNE, and decreased production of cells important to the body may occur. This effect, which can be severe, is usually reversible when the drug is discontinued or the dose is reduced.

Taking ACTIMMUNE may cause reversible changes to your liver function, particularly in patients less than 1 year old. Your doctor should monitor your liver function every 3 months, and monthly in children under 1 year.

In rare cases, ACTIMMUNE can cause severe allergic reactions and/or rash. If you experience a serious reaction to ACTIMMUNE, discontinue it immediately and contact your doctor or seek medical help.

What should I tell my healthcare provider?

Be sure to tell your doctor about all the medications you are taking.

Tell your doctor if you:

  • are pregnant or plan to become pregnant or plan to nurse
  • have a cardiac condition such as irregular heartbeat, heart failure, or decreased blood flow to your heart
  • have a history of seizures or other neurologic disorders
  • have, or have had, reduced bone marrow function. Your doctor will monitor these cells with blood tests at the beginning of therapy and at 3-month intervals on ACTIMMUNE therapy

What are the side effects of ACTIMMUNE?

The most common side effects with ACTIMMUNE are “flu-like” symptoms such as fever, headache, chills, muscle pain, or fatigue, which may decrease in severity as treatment continues. Bedtime administration of ACTIMMUNE may help reduce some of these symptoms. Acetaminophen may be helpful in preventing fever and headache.

What other medications might interact with ACTIMMUNE?

Some drugs may interact with ACTIMMUNE to potentially increase the risk of damage to your heart or nervous system, such as certain chemotherapy drugs. Tell your doctor about all other medications you are taking.

Avoid taking ACTIMMUNE at the same time as a vaccination.

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

The risk information provided here is not comprehensive. To learn more, talk about ACTIMMUNE with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at http://www.ACTIMMUNE.com or 1-866-479-6742.