AVEO ACE - FOTIVDA

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AVEO ACE is for people taking FOTIVDA

AVEO ACE is a comprehensive program that provides personalized and ongoing support to those with advanced RCC. Once you and your doctor have decided that FOTIVDA is right for you, an AVEO ACE Program Specialist can help:

Understand your insurance coverage for FOTIVDA
Learn more about your out-of-pocket costs for treatment
Identify financial support options that may be available
Access helpful resources and personalized nurse support

Get in touch with us

We’re dedicated to helping you understand the programs and resources available to you. Learn how to enroll in the AVEO ACE program and get started.

Call 1-833-FOTIVDA

(1-833-368-4832)

Monday through Friday,
8 AM-8 PM ET.

Enroll

How to enroll

Enroll now

Download and print

the AVEO ACE enrollment form

and fax the completed form
to 1-888-920-2830.

Download now

ACE overview

We know how difficult it can be to understand your health insurance. Your AVEO ACE Program Specialist will work with you and your healthcare provider to access therapy and keep you informed every step of the way.

Check insurance coverage and conduct a benefits investigation to determine coverage for FOTIVDA
Help navigate any prior authorization (PA) required by the insurance plan to facilitate coverage for treatment
Work with you and your doctor to provide appeals support in situations where coverage is denied
Work with the specialty pharmacy to coordinate treatment delivery of your medication directly to you

How do I enroll in AVEO ACE?

Enrolling in AVEO ACE is simple, but requires both you and your doctor to participate. Once you and your doctor decide to move forward with FOTIVDA, follow the steps below to enroll.

Access the patient enrollment form.
Fill out and sign the patient part of the enrollment form and bring it to your next appointment. Your doctor will need to complete and sign the HCP sections.
Once the form is complete, your doctor will submit it along with copies of your prescription insurance cards.
Your AVEO ACE specialist will work with your doctor’s office to get access to FOTIVDA treatment.

Enroll now

Download the form

What happens after my doctor and I enroll?

Once the AVEO ACE Enrollment Form is received, an AVEO ACE Program Specialist will follow up with you regarding next steps within 24 hours.

DISCLAIMER

AVEO ACE makes no representation or guarantee concerning reimbursement or coverage for any service or item. Information provided through the AVEO ACE program does not constitute medical or legal advice and is not intended to be a substitute for a consultation with a licensed healthcare professional, legal counsel, or applicable third-party payer(s). AVEO ACE reserves the right to modify the program at any time without notice.

Ongoing education and support

Your dedicated Nurse Navigator is here to support you every step of the way. Your dedicated Nurse Navigator is a resource that will partner with you to stay on track and offer additional support throughout your FOTIVDA treatment journey. Your Nurse Navigator will help you:

Understand what to expect on FOTIVDA treatment
Support you and your loved ones as you continue your treatment journey

Patient support does not include medical advice. Your healthcare professional should always be your source for information about your condition and treatment.

DISCLAIMER

Resources

Downloadable resources

Get more information about the AVEO ACE program and find helpful tips on caring for someone with advanced kidney cancer by downloading these brochures.

The AVEO ACE brochure

has information on access and financial support.

Download now

The Caregiver Tips brochure

provides helpful resources.

Download now

General cancer support

American Cancer Society

CancerCare

Cancer Hope Network

Cancerhopenetwork.org

877-467-3638

National Cancer Institute (NCI)

Cancer.gov

800-422-6237

Cancer support for advanced kidney cancer

KC Cure

kccure.org

Kidney Cancer Association (KCA)

Kidneycancer.org

800-850-9132

National Kidney Foundation

kidney.org

855-653-2273

DISCLAIMER

Financial assistance

We care about helping you access your FOTIVDA treatment. Your AVEO ACE Program Specialist can help explore financial support options that may be able to help lower your out-of-pocket costs for FOTIVDA.

Copay Assistance Program

Eligible patients may qualify for copay assistance and pay as little as $0. See full eligibility requirements

Enroll in the copay program

FOTIVDA Bridge Program

The FOTIVDA Bridge Program allows those who are already on FOTIVDA treatment to receive free FOTIVDA should they experience a treatment interruption.

FOTIVDA Quick Start Program

The AVEO ACE Quick Start Program provides free FOTIVDA to eligible patients who experience a payer decision delay of 5 business days or more. Once you enroll in the AVEO ACE program, your AVEO ACE Program Specialist can see if you are eligible for the Quick Start Program.

Patient Assistance Program

The FOTIVDA Patient Assistance Program provides FOTIVDA at no cost to eligible patients who are insured or underinsured. Patients who are eligible for copay assistance must be:

A resident of the United States or a US Territory
Uninsured or underinsured
Meet certain income and financial requirements

Other eligibility requirements and restrictions apply.

DISCLAIMER

How to enroll

Enrolling in the AVEO ACE program is your first step towards moving forward in your treatment journey. Once you enroll, you’ll have your own AVEO ACE Program Specialist to guide you through the process of accessing FOTIVDA treatment. You’ll also receive a Patient Welcome Kit, complete with helpful information and tools you can use every day to stay active and engaged with family and friends.

Enroll now

You may also download the enrollment form and bring it with you to your next doctor’s appointment. You and your doctor both need to fill out and sign the form. Once the form is complete, your healthcare professional will submit it along with copies of your prescription insurance cards.

Download the form

Once the AVEO ACE Enrollment Form is received, an AVEO ACE Program Specialist will follow up with you regarding next steps within 24 hours.

Frequently asked questions

ACE Overview

1. What is AVEO ACE?

AVEO ACE (Access Center of Excellence) provides helpful information and resources for patients starting FOTIVDA treatment. ACE can provide personalized support every step of the way throughout your treatment journey.

Once you enroll in ACE, you will have a dedicated ACE Program Specialist to help you understand your insurance coverage. Your specialist will work with your healthcare provider to navigate any prior authorizations or appeals and will help identify financial support programs that might be available to you.

2. How do I enroll in AVEO ACE?

Enrolling in AVEO ACE requires both patients and physicians to complete the enrollment form. Enrollment forms can be completed electronically or downloaded from www.FOTIVDA.com. Patients can enroll and sign the authorization page online or can sign the enrollment form before the healthcare provider faxes it to ACE. If you or your doctor need additional assistance with enrollment, you may call ACE at 1-833-FOTIVDA to speak with an ACE Program Specialist.

Cost and Financial Support

1. What financial assistance is available if I have commercial insurance?

Patients who have commercial or private insurance may be eligible to enroll in the AVEO ACE CoPay Assistance Program. Eligible patients could pay as little as $0 for their FOTIVDA prescription, up to $25,000 per calendar year. Your ACE Program Specialist or your pharmacist can also help enroll you in the copay program. See full eligibility requirements

2. What financial assistance is available if I have Medicare or government insurance?

Patients with government insurance are not eligible for the commercial Copay Program. However, your ACE Program Specialist can help identify financial support that may be available from independent charitable foundations. These foundations are independent of AVEO ACE and have their own eligibility criteria and application processes. The availability of charitable support is determined solely by the individual foundations.

Medicare Extra Help: Some patients enrolled in a Medicare Part D plan may be eligible for Extra Help. The Extra Help program helps lower the cost of prescription drugs for eligible patients. Your ACE Program Specialist can check if you are eligible and guide you on how to apply.

3. What if I do not have health insurance?

If you do not have insurance coverage or have been denied coverage, we may be able to help. Your ACE Program Specialist can see if you are eligible to receive FOTIVDA for free from the AVEO ACE Patient Assistance Program. Patients must be enrolled in AVEO ACE to apply for the ACE Patient Assistance Program and must meet eligibility requirements.

Coverage and Access Assistance

1. How will I know if my FOTIVDA prescription is covered by my insurance?

Your dedicated Program Specialist at ACE will help you understand your insurance coverage. They work with your healthcare provider to navigate any prior authorizations or appeals and will help identify financial support programs that might be available to you. Once a benefits investigation is complete, your specialist will notify you about your insurance company’s decision.

2. What can I do if I receive a denial of coverage?

Specialty medications often require a prior authorization (PA). This is a verification from your doctor that explains that the prescribed medication is medically necessary to treat your condition. If the prior authorization is denied, you have the right to appeal the coverage decision. Your ACE Program Specialist will work with your healthcare provider to support the appeal process and keep you informed every step of the way.

3. What if my physician wants me to start FOTIVDA right away?

Once enrolled with ACE, you may be eligible for our AVEO ACE Quick Start Program which provides medication to patients at no cost if there is a delay in obtaining coverage for the FOTIVDA prescription. Your ACE Program Specialist can check if you are eligible for the Quick Start Program.

4. How will I receive FOTIVDA once coverage is approved?

Patients can access FOTIVDA through one of our limited distribution specialty pharmacies or through your healthcare providers on-site pharmacy if available. Your ACE Program Specialist can help make sure your prescription is sent to the appropriate pharmacy for processing.

Other Questions

1. How can ACE help me stay on track with my FOTIVDA treatment?

Patients enrolled in AVEO ACE will receive support from a specially trained Oncology Nurse Navigator. Your Nurse Navigator will provide you with general education on FOTIVDA treatment, educational resources, and personalized support to help you stay on track during your treatment journey. Patient support and education does not include medical advice.

2. How can I contact ACE if I have more questions?

Patients or healthcare providers can contact AVEO ACE at 1-833-FOTIVDA (1-833-368-4832). ACE Program Specialists are available Monday through Friday, 8 AM to 8 PM ET.

The FOTIVDA® (tivozanib) Copay Card program provides eligible, commercially insured patients up to $25,000 per calendar year toward a patient’s FOTIVDA prescription costs. The FOTIVDA Copay Card program is not valid for uninsured patients. Annual and transaction limits apply. No other purchase is necessary.

Eligible patients must be prescribed FOTIVDA for an FDA-approved indication.

Eligible patients with a FOTIVDA prescription may pay as little as $0 toward their out-of-pocket costs. Patients must be 18 years or older to enroll and activate a copay card. The program can only be used by eligible residents of the United States, Puerto Rico, and Guam, and at participating pharmacies. The offer does not constitute prescription drug coverage and is not intended to substitute for health insurance. The offer is not available to patients receiving any form of prescription coverage under any federal, state, or government-funded insurance program or where prohibited by law. Such programs include Medicare (including Medicare Part D and Medicare Advantage), Medicaid, TRICARE, Department of Defense, and Veterans Affairs programs. If at any time a patient begins receiving prescription drug coverage under any federal, state, or government-funded healthcare program, the patient will no longer be able to use the FOTIVDA Copay Card and the patient must call AVEO ACE patient support at 1-833-368-4832 to terminate participation.

This offer cannot be combined with any other coupon, free trial, discount, prescription savings card, or similar offering. Patients who are members of insurance plans that adjust their patients’ out-of-pocket or co-insurance responsibilities for certain prescription drugs based upon the patient’s enrollment in manufacturer-sponsored copay assistance for such drugs (often termed “accumulator” or “maximizer” programs) may be restricted from using the FOTIVDA Copay Card. AVEO ACE reserves the right to reduce or eliminate the copay assistance available to patients enrolled in an accumulator or maximizer program.

The value of this program is exclusively for the benefit of patients and is intended to be credited toward patient out-of-pocket obligations and maximums, including applicable copayments, coinsurance, and deductibles. Patients are responsible for any out-of-pocket costs beyond the program’s annual maximum benefit. By redeeming this offer, the patient and pharmacist agree to not seek reimbursement for value received from the FOTIVDA Copay program from any third-party payers. Restrictions, including monthly maximums, may apply.

To participate in the FOTIVDA Copay Card program, the patient will be asked to provide personal information such as name, date of birth, contact information, and insurance carrier. The information provided is needed for the program processor to enroll the patient and apply the benefits of the copay card program. The data shared with AVEO Pharmaceuticals, Inc (“AVEO Oncology”) will be aggregated and de-identified and used by AVEO Oncology to monitor internal business activities and to modify or improve the program. For more information, please see AVEO Oncology’s privacy policy at www.aveooncology.com/privacy-policy.

AVEO ACE reserves the right to terminate, rescind, revoke, or modify the copay card program at any time without notice.

FOTIVDA^® (tivozanib) is a prescription medicine used to treat adults with advanced kidney cancer (advanced renal cell carcinoma or RCC) that has been treated with 2 or more prior medicines and has come back or did not respond to treatment.

IMPORTANT SAFETY INFORMATION

Possible serious side effects can occur with FOTIVDA. Call or see your healthcare provider right away if you develop:

High blood pressure (hypertension). High blood pressure may be severe, including a sudden, severe increase in your blood pressure (hypertensive crisis) that can lead to death. Your healthcare provider should check your blood pressure after 2 weeks and at least monthly, and may prescribe medicine to treat high blood pressure. You should check your blood pressure regularly and tell your healthcare provider if you have increased blood pressure or experience confusion, headaches, dizziness, chest pain, or shortness of breath.

IMPORTANT SAFETY INFORMATION

Possible serious side effects can occur with FOTIVDA. Call or see your healthcare provider right away if you develop:

Heart failure. Heart failure may be serious and sometimes lead to death. Your healthcare provider should check for symptoms of heart failure regularly, such as shortness of breath or swelling of your ankles.

Heart attack and blood clots in your veins or arteries. Blood clots may be serious and sometimes lead to death. Tell your healthcare provider or get emergency medical help right away if you have:

new chest pain or pressure
numbness or weakness on one side of your body
pain in your arms, back, neck or jaw
trouble talking

shortness of breath
sudden severe headache
vision changes
swelling in the arms or legs

Bleeding problems. Bleeding may be serious and sometimes lead to death. Report or get medical help right away if you have:

unusual bleeding from the gums
red or black stools (looks like tar)
menstrual bleeding or vaginal bleeding that is heavier than normal
bruises that happen without a known cause or get larger
headaches, feeling dizzy or weak

bleeding that is severe or you cannot control
coughing up blood or blood clots
pink or brown urine
vomiting blood or your vomit looks like “coffee grounds”
unexpected pain, swelling, or joint pain

Protein in your urine. Your healthcare provider should check your urine for protein before and during treatment.

Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment, and may prescribe medicine if you develop thyroid gland problems.

Risk of wound-healing problems. Wounds may not heal properly during treatment. Tell your healthcare provider if you plan to have surgery before starting or during treatment, including dental surgery.

You should stop taking FOTIVDA at least 24 days before planned surgery.
Your healthcare provider should tell you when you may start taking FOTIVDA again after surgery.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS). RPLS is a condition that can happen. Tell your healthcare provider right away if you have headaches, seizures, confusion, blindness or changes in vision, or difficulty thinking.

Allergic reactions to tartrazine (FD&C Yellow No. 5). FOTIVDA contains a dye called FD&C Yellow No. 5 (tartrazine) that may cause allergic-type reactions, including bronchial asthma, in certain people. This occurs most often in people who also are allergic to aspirin.

The most common side effects of FOTIVDA include:

tiredness
diarrhea
decreased appetite
nausea

hoarseness
low levels of thyroid hormones
cough
mouth sores

decreased blood levels of salt (sodium) and phosphate
increased levels of lipase in the blood

Other side effects include vomiting and weakness or lack of energy. FOTIVDA may cause fertility problems in males and females, which may affect your ability to have a child.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with FOTIVDA if you have certain side effects.

These are not all of the possible side effects of FOTIVDA.

Before taking FOTIVDA, tell your healthcare provider about all your medical conditions, including if you:

have high blood pressure.
have a history of heart failure.
have a history of blood clots in your veins or arteries (types of blood vessels), including stroke, heart attack, or change in vision.
have bleeding problems.
have thyroid problems.
have liver problems.
have an unhealed wound.
plan to have surgery or have had recent surgery, including dental surgery. You should stop taking FOTIVDA at least 24 days before planned surgery.
are allergic to FD&C Yellow No.5 (tartrazine) or aspirin.
are pregnant or plan to become pregnant. FOTIVDA can harm your unborn baby. If you are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment.
- Use effective birth control (contraception) during treatment and for 1 month after your last dose.
- Talk to your healthcare provider about birth control methods that may be right for you.
- Tell your healthcare provider right away if you become pregnant or think you might be pregnant.

Tell your healthcare provider about all the medicine you take and any new medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FOTIVDA with certain other medicines may affect how FOTIVDA works.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the Patient Information in the full Prescribing Information for FOTIVDA^® (tivozanib).