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 RAVICTI 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

Insurance Approval Process

Insurance Approvals and Amgen By Your Side

The insurance approval process for RAVICTI® (glycerol phenylbutyrate) Oral Liquid 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
  • 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

Enroll to get PAL assistance with the approval 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. 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

Read Transcript

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 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.

USE and IMPORTANT SAFETY INFORMATION

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

RAVICTI may cause serious side effects, including:
Nervous system side effects (Neurotoxicity)
Phenylacetate (PAA), a breakdown product of RAVICTI, may cause nervous system side effects. Call your doctor or get medical help right away if you have any of these symptoms while taking RAVICTI:

  • sleepiness
  • lightheadedness
  • change in taste
  • problems with hearing
  • confusion
  • problems with memory
  • worsening of numbness, tingling, or burning in your hands or feet
  • headache
  • feeling very tired (fatigue)
  • nausea
  • vomiting

Your doctor may do blood tests to measure the amount of PAA in your blood during your treatment with RAVICTI.

What is RAVICTI?

  • RAVICTI (glycerol phenylbutyrate) Oral Liquid is a prescription medicine used for long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (UCD). RAVICTI should be used if the UCD cannot be managed with a low-protein diet and dietary supplements alone. RAVICTI must be used along with a low-protein diet and in some cases dietary supplements.
  • RAVICTI is not used for the acute treatment of hyperammonemia in people with UCD.
  • It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.

Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you have wheezing, shortness of breath, cough, low blood pressure, flushing, nausea or a rash while taking RAVICTI.

Before taking RAVICTI, tell your doctor about all of your medical conditions, including if you:

  • have liver or kidney problems.
  • have pancreas or bowel (intestine) problems.
  • are pregnant or plan to become pregnant. It is not known if RAVICTI will harm your unborn baby. If you become pregnant during treatment with RAVICTI, call Amgen at 1-866-479-6742 to report the pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if RAVICTI passes into your breast milk. Breastfeeding is not recommended during treatment with RAVICTI. Talk to your doctor about the best way to feed your baby if you take RAVICTI.

What are possible side effects of RAVICTI?

RAVICTI may cause serious side effects, including:

  • See “What is the most important information I should know about RAVICTI?”

The most common side effects of RAVICTI in adults include:

  • diarrhea
  • gas
  • headache
  • abdomen (stomach) pain
  • vomiting
  • tiredness
  • decreased appetite
  • indigestion or heartburn

The most common side effects of RAVICTI in children 2 years to 17 years of age include:

  • upper abdomen (stomach) pain
  • rash
  • nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • headache

The most common side effects of RAVICTI in children 2 months to less than 2 years of age include:

  • low white blood cell count (neutropenia)
  • vomiting
  • constipation
  • diarrhea
  • fever
  • reduced food intake
  • cough
  • stuffy nose
  • runny nose
  • skin rash
  • small round bumps on the skin

The most common side effects of RAVICTI in children less than 2 months of age include:

  • vomiting
  • rash
  • gastroesophageal reflux
  • increased levels of liver enzymes in the blood
  • decreased appetite and reduced food intake
  • low red blood cell count (anemia)
  • cough
  • loss of too much body fluid (dehydration)
  • too much acid in the blood (acidosis)
  • high blood platelet count (thrombocytosis)
  • low blood platelet count (thrombocytopenia)
  • low blood neutrophil count (type of white blood cell) (neutropenia)
  • high white blood cell count (lymphocytosis)
  • diarrhea
  • gas
  • constipation
  • fever
  • drowsiness (lethargy)
  • irritability
  • agitation

These are not all of the possible side effects of RAVICTI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For additional Important Safety Information, click here for the Medication Guide and discuss with your doctor.

USE and IMPORTANT SAFETY INFORMATION

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

RAVICTI may cause serious side effects, including:
Nervous system side effects (Neurotoxicity)
Phenylacetate (PAA), a breakdown product of RAVICTI, may cause nervous system side effects. Call your doctor or get medical help right away if you have any of these symptoms while taking RAVICTI:

  • sleepiness
  • lightheadedness
  • change in taste
  • problems with hearing
  • confusion
  • problems with memory
  • worsening of numbness, tingling, or burning in your hands or feet
  • headache
  • feeling very tired (fatigue)
  • nausea
  • vomiting

Your doctor may do blood tests to measure the amount of PAA in your blood during your treatment with RAVICTI.

What is RAVICTI?

  • RAVICTI (glycerol phenylbutyrate) Oral Liquid is a prescription medicine used for long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (UCD). RAVICTI should be used if the UCD cannot be managed with a low-protein diet and dietary supplements alone. RAVICTI must be used along with a low-protein diet and in some cases dietary supplements.
  • RAVICTI is not used for the acute treatment of hyperammonemia in people with UCD.
  • It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.

Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you have wheezing, shortness of breath, cough, low blood pressure, flushing, nausea or a rash while taking RAVICTI.

Before taking RAVICTI, tell your doctor about all of your medical conditions, including if you:

  • have liver or kidney problems.
  • have pancreas or bowel (intestine) problems.
  • are pregnant or plan to become pregnant. It is not known if RAVICTI will harm your unborn baby. If you become pregnant during treatment with RAVICTI, call Amgen at 1-866-479-6742 to report the pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if RAVICTI passes into your breast milk. Breastfeeding is not recommended during treatment with RAVICTI. Talk to your doctor about the best way to feed your baby if you take RAVICTI.

What are possible side effects of RAVICTI?

RAVICTI may cause serious side effects, including:

  • See “What is the most important information I should know about RAVICTI?”

The most common side effects of RAVICTI in adults include:

  • diarrhea
  • gas
  • headache
  • abdomen (stomach) pain
  • vomiting
  • tiredness
  • decreased appetite
  • indigestion or heartburn

The most common side effects of RAVICTI in children 2 years to 17 years of age include:

  • upper abdomen (stomach) pain
  • rash
  • nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • headache

The most common side effects of RAVICTI in children 2 months to less than 2 years of age include:

  • low white blood cell count (neutropenia)
  • vomiting
  • constipation
  • diarrhea
  • fever
  • reduced food intake
  • cough
  • stuffy nose
  • runny nose
  • skin rash
  • small round bumps on the skin

The most common side effects of RAVICTI in children less than 2 months of age include:

  • vomiting
  • rash
  • gastroesophageal reflux
  • increased levels of liver enzymes in the blood
  • decreased appetite and reduced food intake
  • low red blood cell count (anemia)
  • cough
  • loss of too much body fluid (dehydration)
  • too much acid in the blood (acidosis)
  • high blood platelet count (thrombocytosis)
  • low blood platelet count (thrombocytopenia)
  • low blood neutrophil count (type of white blood cell) (neutropenia)
  • high white blood cell count (lymphocytosis)
  • diarrhea
  • gas
  • constipation
  • fever
  • drowsiness (lethargy)
  • irritability
  • agitation

These are not all of the possible side effects of RAVICTI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For additional Important Safety Information, click here for the Medication Guide and discuss with your doctor.