Copay Card Terms and Conditions | TAVNEOS® (avacopan)

Approved Use: TAVNEOS® is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe

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Approved Use: TAVNEOS® is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener’s granulomatosis, and microscopic polyangiitis [MPA]). It is not known if TAVNEOS is safe and effective in children under the age of 18.

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TAVNEOS® Copay Card Terms and Conditions

Summary of Terms and Conditions

It is important that every patient read and understand the full TAVNEOS Copay Card Terms and Conditions. The following summary is not a substitute for reviewing the Terms and Conditions in their entirety.

As further described below, in general:

  • The TAVNEOS Copay Card is open to TAVNEOS patients with commercial insurance that covers TAVNEOS, regardless of financial need. The program is not valid for patients whose TAVNEOS prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state healthcare program. It is not valid for cash paying patients or where prohibited by law. (See ELIGIBILITY section in full Terms & Conditions.)
  • The TAVNEOS Copay Card may help lower your TAVNEOS out-of-pocket medication costs. Out-of-pocket costs may include co-payment, co-insurance, and deductible out-of-pocket costs. The TAVNEOS Copay Card does not cover any other costs related to office visits or administration of the product. The Amgen TAVNEOS Copay Card provides support up to the Maximum Program Benefit or Patient Total Program Benefit. If a patient’s commercial insurance plan imposes different or additional requirements on patients who receive TAVNEOS Copay Card benefits, Amgen has the right to modify or eliminate those benefits. Whether you are eligible to receive the Maximum Program Benefit or Patient Total Program Benefit is determined by the type of plan coverage you have. Please ask your TAVNEOS Representative to help you understand eligibility for the TAVNEOS Copay Card, whether your particular insurance coverage is likely to result in your reaching the Maximum Program Benefit or your Patient Total Program Benefit amount by calling 1-833-TAVNEOS (833-828-6367). (See PROGRAM BENEFITS section in full Terms & Conditions.)
  • TAVNEOS patient may pay as little as $0 out-of-pocket for each prescription fill, dose or cycle of TAVNEOS.
  • Amgen will pay the remaining eligible out-of-pocket costs on behalf of the patient until the Amgen payments have reached either the Maximum Program Benefit and/or the Patient Total Program Benefit. Patients are responsible for all amounts that exceed this limit. Please ask your TAVNEOS Representative to help you understand eligibility for the TAVNEOS Copay Card by calling 1-833-TAVNEOS (833-828-6367). (See PROGRAM DETAILS section in full Terms & Conditions.)

I. ELIGIBILITY

*Eligibility Criteria: Subject to program limitations and terms and conditions, the TAVNEOS Copay Card is open to patients who have been prescribed TAVNEOS and who have commercial or private insurance that covers TAVNEOS, including state and federal plans commonly referred to as “healthcare exchanges plans”. This program helps eligible patients cover out-of-pocket medication costs related to TAVNEOS, up to program limits. The TAVNEOS Copay Card does not cover any other costs related to office visits or administration of TAVNEOS. There is no income requirement to participate in this program.

This offer is not valid for patients whose prescription for TAVNEOS is paid for in whole or in part by Medicare, Medicaid, or any other federal or state healthcare program. It is not valid for cash-paying patients or where prohibited by law. A patient is considered cash-paying where the patient has no insurance coverage for TAVNEOS or where the patient has commercial or private insurance but Amgen in its sole discretion determines the patient is effectively uninsured because such coverage does not provide a material level of financial assistance for the cost of a TAVNEOS prescription. This offer is only valid in the United States and Puerto Rico.

II. PROGRAM BENEFITS

The TAVNEOS Copay Card may modify the benefit amount, unilaterally determined by Amgen in its sole discretion, to satisfy the out-of-pocket cost sharing requirement for any patient whose plan or plan agent (including, but not limited to, a Pharmacy Benefit Manager (PBM)) requires enrollment in the Amgen TAVNEOS Copay Card as a condition of the plan or PBM waiving some or all of an otherwise applicable patient out-of-pocket cost sharing amount. These programs are often referred to as copay maximizer programs. If you believe your commercial insurance plan may have such limitations, please contact the TAVNEOS Team at 1-833-TAVNEOS (833-828-6367). Health plans and Pharmacy Benefit Managers are prohibited from enrolling or assisting in the enrollment of patients in the TAVNEOS Copay Card. The patient, or his/her legal representative, must personally enroll in the TAVNEOS Copay Card in order to be eligible for program benefits.

If at any time a patient begins receiving coverage for medications under any federal, state, or government healthcare program (including but not limited to Medicare, Medicaid, TRICARE, Department of Defense, or Veteran Affairs programs), the patient will no longer be able to use this card and you must contact the TAVNEOS Team at 1-833-TAVNEOS (833-828-6367) to stop your participation in this program.

Patients may not seek reimbursement for the value received from the TAVNEOS Copay Card from any third-party payers, including a flexible spending account or healthcare savings account. Participating in this program means that you are ensuring you comply with any required disclosure regarding your participation in the TAVNEOS Copay Card of your insurance carrier or pharmacy benefit manager. Restrictions may apply. Offer subject to change or discontinuation without notice. This is not health insurance.

III. PROGRAM DETAILS

For all eligible patients the TAVNEOS Copay Card offers:

  • A program benefit that covers the patient’s eligible out-of-pocket medication costs for TAVNEOS (copay, deductible, or co-insurance) on behalf of the patient, up to a Maximum Program Benefit determined by the program per calendar year. The TAVNEOS Copay Card does not cover any other costs related to office visits.
  • TAVNEOS patients may pay as little as $0 out-of-pocket for each prescription fill, dose or cycle.
  • Amgen will pay the remaining eligible out-of-pocket prescription costs on behalf of the patient until the Amgen payments have reached either the Maximum Program Benefit and/or the Patient Total Program Benefit. Patients are responsible for all amounts that exceed this limit.

Maximum Program Benefit, Patient Total Program Benefit, Benefits May Change, End or Vary Without Notice: The program provides up to a Maximum Program Benefit of support to reduce a patient’s out-of-pocket medication costs that Amgen will provide per patient for each calendar year, which must be applied to the TAVNEOS patient’s out-of-pocket costs (copay, deductible, or co-insurance and annual out-of-pocket maximum). Patient Total Program Benefit amounts are unilaterally determined by Amgen in its sole discretion and will not exceed the Maximum Program Benefit. The Patient Total Program Benefit may be less than the Maximum Program Benefit, depending on the terms of a patient’s plan, and may vary among individual patients covered by different plans, based on factors determined solely by Amgen, to ensure all programs funds are used for the benefit of the patient. Each patient is responsible for costs above the Patient Total Program Benefit amounts. Please ask your TAVNEOS Representative to help you understand whether your particular insurance coverage is likely to result in your reaching the Maximum Program Benefit or your Patient Total Program Benefit amount by calling 1-833-TAVNEOS (833-828-6367). Participating patients are solely responsible for updating Amgen with changes to their insurance including, but not limited to, initiation of insurance provided by the government, the addition of any coverage terms that do not apply TAVNEOS Copay Card benefits to reduce a patient’s out-of-pocket costs, such as accumulator adjustment benefit design or a copay maximization program. Participating patients are responsible for providing Amgen with accurate information necessary to determine program eligibility. By accepting payments from Amgen made on behalf of participating patients, participating PBMs and Plans likewise are responsible for providing Amgen with accurate information regarding patient eligibility.

Patients may use the card every time they receive a prescription fill, dose or cycle of TAVNEOS, up to the Maximum Program Benefit or Patient Total Program Benefit. Benefits reset each calendar year. Re-enrollment in the program is required at regular intervals. Patients may continue in the program as long as patient re-enrolls as required by Amgen and continues to meet all of the program’s eligibility requirements during participation in the program. Patients can enroll/reenroll by calling 1-833-TAVNEOS (833-828-6367).

IMPORTANT SAFETY INFORMATION

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

TAVNEOS can cause serious side effects, including:

  • Liver problems. People taking TAVNEOS may have serious liver problems. Call your healthcare provider right away if you have unexplained symptoms such as:
    • yellowing of your skin or the white part of your eyes (jaundice)
    • pain on the upper right side of your stomach area (abdomen)
    • feeling tired
    • dark or brown (tea colored) urine
    • bleeding or bruising more easily than normal
    • loss of appetite

Your healthcare provider will do blood tests to check how well your liver is working before starting and during your treatment with TAVNEOS.

Do not take TAVNEOS if you are allergic to avacopan or any of the other ingredients in TAVNEOS.

  • Get medical help right away if you experience swollen lips, tongue, throat, trouble swallowing, or difficulty breathing. These could be signs of an allergic reaction. Do not take more TAVNEOS until you have consulted with your healthcare provider.

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

  • have or have had abnormal liver blood tests.
  • have or have had liver problems.
  • have or think you may have hepatitis B or C.
  • have an infection.
  • are pregnant or are planning to become pregnant. It is not known if TAVNEOS will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if TAVNEOS can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take TAVNEOS.

Tell your healthcare provider about all the other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAVNEOS and certain other medicines may affect each other and cause side effects. Keep a list of the medicines you take and show it to your healthcare provider and pharmacist.

  • Some medicines should not be taken with TAVNEOS.
  • Your healthcare provider may prescribe other medicines to treat your disease.

TAVNEOS may cause serious side effects, including:

  • Liver problems (see above).
  • Serious allergic reactions. Stop taking TAVNEOS and get emergency medical help right away if you have any of the following signs of a serious allergic reaction: shortness of breath or trouble breathing; swollen lips, tongue, throat, or face; trouble swallowing; chest pain; feeling dizzy or faint; moderate or severe abdominal pain, or vomiting.
  • Hepatitis B virus (HBV) reactivation. If you have had HBV or are a carrier of HBV, taking TAVNEOS could cause the virus to become an active infection again. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or the white part of your eyes during treatment with TAVNEOS.
  • Serious infections. Serious infections can happen in people taking TAVNEOS, and these infections can lead to death. The most

    common serious infections with TAVNEOS were pneumonia and urinary tract infections. People with serious infections should not take TAVNEOS. Tell your healthcare provider right away if you have any symptoms of infection: fever, cold symptoms that do not go away, flu symptoms, pain during urination, or other signs of infection.

The most common side effects of TAVNEOS include:

  • nausea, headache, high blood pressure, diarrhea, vomiting, rash, tiredness, stomach pain, dizziness, increase in blood creatinine, and burning or prickling sensation.

What is TAVNEOS?

TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener’s granulomatosis, and microscopic polyangiitis [MPA]).

It is not known if TAVNEOS is safe and effective in children under the age of 18.

These are not all the possible side effects of TAVNEOS. Call your doctor for medical advice about side effects. Please see the Full Prescribing Information and Medication Guide for further details.

TAVNEOS is available as a 10 mg capsule.

You are encouraged to report negative side effects to Amgen at 1-833-828-6367 or to the FDA by

visiting www.fda.gov/medwatch or calling 1-800-332-1088.

IMPORTANT SAFETY
INFORMATION
What is the most important information I should know about TAVNEOS?

TAVNEOS can cause serious side effects, including: Liver problems. People taking TAVNEOS may have serious liver problems.
Call your healthcare provider right away if you have unexplained symptoms such as: yellowing of your skin or the white part…

IMPORTANT SAFETY INFORMATION What is the most important information I should know about TAVNEOS? TAVNEOS can cause serious side effects, including: Liver problems. People taking TAVNEOS may have serious liver problems. Call your healthcare provider right away if you have unexplained symptoms such as: