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Celltrion CARES™ Co-pay Assistance Program:
Adalimumab-aaty Terms and Conditions

These Terms and Conditions are valid for Adalimumab-aaty as of the date published until amended or terminated by Celltrion (“Program Period”). As a condition of participation in the Program, participants understand and agree that Celltrion may, in its sole discretion, limit, rescind, revoke, terminate, or amend the Program at any time, for any reason, without notice. It is the responsibility of participants to review these Terms and Conditions each time before relying on any Program benefits.

1. Program Overview

The Celltrion CARES™ Co-pay Assistance Program (“Program”) seeks to help Eligible Patients (defined below) with certain out-of-pocket costs (OOP) for Adalimumab-aaty. Under the Program, Eligible Patients may pay as little as $0 for Adalimumab-aaty each time they present their co-pay card to fill their prescription. The Program is subject to certain limitations set out below, including Qualifying Expenses (defined below), maximum limits, available funding, and patient eligibility requirements or other restrictions. Actual per prescription savings for Qualifying Expenses may vary, and patients may be responsible for OOP costs not covered under this Program.

2. Patient Eligibility

To qualify for Program benefits, the patient must meet the following eligibility requirements (“Eligible Patients”):

  • Have Commercial Insurance: Patient must have and use private/commercial health insurance that provides at least some coverage for Adalimumab-aaty. Patients who do not have coverage for Adalimumab-aaty or do not elect to use their commercial health plan to cover at least some of the cost of Adalimumab-aaty are ineligible for the Program. Additionally, patients are ineligible for the Program where their insurance policy prohibits such co-pay assistance programs. It is the patient’s responsibility to check with their insurance carrier to confirm that their participation in the Program is not inconsistent with insurance carrier’s requirements; including satisfying any conditions imposed by their carrier for participation in the Program.   
  • No Federal or State Health Insurance: Patients are ineligible for the Program if they are covered, in whole or in part, under:
    • Medicaid (including Medicaid patients enrolled in a qualified health plan purchased through a health insurance exchange marketplace established by a state government or the federal government),
    • Medicare (Part A or B),
    • Medicare Part D or Medicare Advantage plan (regardless of whether a specific prescription is covered),
    • TRICARE, Veterans Affairs healthcare or the Civilian Health and Medical Program (CHAMPVA),
    • Puerto Rico Government Health Insurance Plan (“Healthcare Reform” formerly known as “La Reforma de Salud”),
    • A State prescription drug assistance program, or
    • Any other state or federal medical or pharmaceutical benefit program or pharmaceutical assistance program (collectively, “Government Programs”).

If at any time in the future, a patient begins receiving prescription drug coverage for Adalimumab-aaty under any such Government Program(s), the patient is ineligible for the Program and must call Celltrion CARES™ at 1-877-81CONNC (1-877-812-6662) to stop participation in the Program immediately.

  • No Self-Pay: The Program is not valid for self-pay or cash-paying patients (i.e., patients without commercial health insurance, patients with health insurance who lack coverage for Adalimumab-aaty, or patients who do not seek to use commercial health insurance to pay for Adalimumab-aaty under their plan).
  • Residency & Age: Patient must be 18 years of age or older (or have a caregiver or legal guardian duly authorized to provide legal consent to these Terms and Conditions on behalf of the patient) and reside in the United States or the Commonwealth of Puerto Rico for at least 6 months and live within and under the guidance of a healthcare provider (HCP) within the United States or the Commonwealth of Puerto Rico. Additionally, Adalimumab-aaty covered under the Program must originate and be shipped to locations in the United States or the Commonwealth of Puerto Rico.
  • On-label Prescription: Patient must be under the care of a physician and prescribed Adalimumab-aaty for an FDA-approved indication. Please see the full Prescribing Information here for a complete list of FDA-approved indications.

3. Program Enrollment for Co-pay Cards

  • Eligible Patients must be enrolled in the Program and meet all Patient Eligibility requirements. 
  • Patients or their duly licensed provider(s), pharmacist(s), caretakers or legal guardians may complete Program enrollment process either via the Celltrion CONNECT® Patient Support Program or online through the Celltrion CARES™ website.
  • Patients, or those enrolling on behalf of the patient agree to provide all required information and legal consents necessary for Program administration by Celltrion CARES™. Anyone enrolling the patient in the Program represents and warrants all information provided is true and accurate as of the date provided.
  • Celltrion CARES™ will review the application to determine if the Patient is Eligible for the Program.
  • If the patient is eligible for the program, Celltrion CARES™ will provide the Eligible Patient with virtual co-pay card details that can be used to cover the cost of Qualifying Expenses at their dispensing pharmacy.

4. Patient Enrollment for Rebates

  • If a patient’s retail or specialty pharmacy does not participate in the Program, Eligible Patients may be able to submit a request for a rebate in connection with any Qualifying Expenses. To apply for a co-pay rebate, Eligible Patients must submit Qualifying Expenses according to the rebate process found at www.patientrebateonline.com.
  • For Eligible Patients who are receiving their medication via mail order pharmacies that do not allow the use of co-pay cards, Eligible Patients must submit Qualifying Expenses according to the rebate process found at www.patientrebateonline.com.
  • Patients may also apply for a rebate for Qualifying Expense incurred for Adalimumab-aaty within 90 days prior to the date the patient is enrolled in the Program based on the Adalimumab-aaty administration date. patient, provider, or pharmacy may contact Celltrion CARES™ for more information.

5. Qualifying Expenses

  • Qualifying Expenses: Are those OOP costs incurred by Eligible Patients for Adalimumab-aaty under their commercial insurance plan during the Program period, subject to maximum allowable limits. Qualifying Expenses are not valid for ancillary services including office visit charges or medication administration charges even if such costs are associated with the administration of Adalimumab-aaty. Enrolled patients are responsible for all co-pays, deductibles, coinsurance, and any other balances not covered by the Program.
  • Maximum Limit: Is the total maximum limit an Eligible Patient may receive for Qualifying Expenses during the Program calendar year. The maximum limit is set by Celltrion CARES™ and may be subject to change.
  • Adjustments: Qualifying Expenses may be adjusted if accumulator or maximizer programs are in effect to ensure that the Program is for the sole benefit of the patient.

6. Additional Restrictions

  • The co-pay card is limited to one Eligible Patient per application and may only be used by such patient during the Program Period. The co-pay card is void if transferred or substituted to any other person or be combined with any other co-pay assistance program, free trial, discount, prescription savings card, or other offer. Co-pay cards may also not be offered for sale, sold, purchased, traded, reproduced, counterfeited, or duplicated.
  • Patient, pharmacy, and provider agree not to seek reimbursement for all, or any part of the benefit received by the patient through the Program and are responsible for reporting receipt of Program benefits to any insurer, health plan, or other third party who pays for or reimburses any part of the medication cost paid for by the Program, as may be required.
  • Patients must promptly contact Celltrion CARES™ if their insurance coverage changes.
  • The Program is not contingent on any past or future commercial sale of Adalimumab-aaty or otherwise void where prohibited by law, taxed, or restricted.

7. Consents and Disclaimers

  • Data Use and Consent: Data related to a patient’s participation in the Program may be collected, analyzed, or shared with Celltrion CARES™ for market research and other purposes related to assessing its co-pay assistance programs. Data shared with Celltrion CARES™ for these purposes will be de-identified, meaning it will not identify the patient specifically.
  • Modification and Termination of Program: Celltrion CARES™ reserves the right to limit, rescind, revoke, terminate, or amend the Program at any time without notice.

IMPORTANT SAFETY INFORMATION AND INDICATIONS
ABOUT Adalimumab-aaty

What is the most important information I should know about Adalimumab-aaty?

You should discuss treatment characteristics of Adalimumab-aaty with your doctor, including potential benefits and risks. Adalimumab-aaty is a TNF blocker medicine that can lower the ability of your immune system to fight infections. Notify your doctor if you have any kind of infection before and after you start taking Adalimumab-aaty.

Serious infections have happened in people taking adalimumab products, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some of these infections have been fatal. Your doctor should test you for TB prior to treatment with Adalimumab-aaty, and monitor closely for signs and symptoms of TB throughout treatment with Adalimumab-aaty, regardless of your TB test results. Your doctor may choose to treat you with a medicine for TB if they feel you are at risk.

Cancer. Taking TNF blockers, such as adalimumab, may increase the risk of cancer, including unusual types, in both children and adults. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma, which is often fatal. Your chance of getting two types of skin cancer (basal cell and squamous cell) may increase while using TNF blockers, including adalimumab. Basal cell and squamous cell skin cancer are typically not life-threatening if treated. You should tell your doctor if you notice a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting Adalimumab-aaty?

Give your doctor a complete description of your health, including the following:

  • Current infection, treatment for infection, or symptoms of an infection
  • Frequent infections or infections that don’t resolve with treatment
  • Diabetes
  • Confirmed TB or close contact with someone who has TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Current or prior residence in major river valleys where risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis) is increased. These infections may happen or become more severe if you use Adalimumab-aaty. Ask your doctor about these infections to check if they are common in your area
  • Current or prior hepatitis B infection
  • Scheduled for major surgery
  • Current or prior cancer
  • Disease that affects your nervous system that results in numbness or tingling in your extremities (multiple sclerosis, Guillain-Barré syndrome, etc.)
  • Heart failure
  • Recent or scheduled vaccines. While taking Adalimumab-aaty, patients may continue to receive vaccines except for live vaccines. Children should receive all recommended vaccines before starting Adalimumab-aaty
  • Known allergy to Adalimumab-aaty or any of its ingredients
  • Current or planned pregnancy, or if you are currently breastfeeding or plan to
  • If you have a baby while taking Adalimumab-aaty during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also, tell your doctor about all the medicines you take. You should not take Adalimumab-aaty with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).

What should I watch for AFTER starting Adalimumab-aaty?

Adalimumab products, including Adalimumab-aaty, can cause serious side effects, including the following:

  • Serious infections. Any infection caused by viruses, fungi, or bacteria, including TB. Common TB symptoms include cough, low-grade fever, weight loss, or loss of body fat and muscle.
  • Hepatitis B infection in carriers of the virus. Common hepatitis B symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
  • Allergic reactions. Common symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of the face, eyes, lips, or mouth.
  • Nervous system problems. Common signs and symptoms include numbness or tingling, problems with vision, weakness in your arms or legs, and dizziness.
  • Blood problems (decreased blood cells that help fight infections or stop bleeding). Common symptoms include a fever that does not go away, bruising or bleeding very easily, or very pale skin tone.
  • Heart failure (new or worsening). Common symptoms include shortness of breath, swelling in the ankles or feet, and sudden weight gain.
  • Immune reactions including a lupus-like syndrome. Common symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on cheeks or arms that gets worse in the sun.
  • Liver problems. Common symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of the stomach (abdomen). These problems can lead to liver failure and death.
  • Psoriasis (new or worsening). Common symptoms include red scaly patches or raised, pus-filled bumps.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of adalimumab products include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, and rash. These are not all the possible side effects with adalimumab products, including Adalimumab-aaty. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

  • Fever, sweats, or chills
  • Muscle aches
  • Cough
  • Shortness of breath
  • Blood in phlegm
  • Weight loss
  • Warm, red, or painful skin or sores on your body
  • Diarrhea or stomach pain
  • Burning when you urinate
  • Urinating more often than normal
  • Feeling very tired

Adalimumab-aaty is given by injection under the skin.

This is the most important information to know about Adalimumab-aaty. For more information, talk to your health care provider.

Indications

Adalimumab-aaty is a prescription medicine used:

  • To reduce the signs and symptoms of:
    • Moderate to severe rheumatoid arthritis (RA) in adults. Adalimumab-aaty can be used alone, with methotrexate, or with certain other medicines.
    • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. Adalimumab-aaty can be used alone or with methotrexate.
    • Psoriatic arthritis (PsA) in adults. Adalimumab-aaty can be used alone or with certain other medicines.
    • Ankylosing spondylitis (AS) in adults.
    • Moderate to severe hidradenitis suppurativa (HS) in adults.
  • To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if Adalimumab-aaty is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
  • To treat moderate to severe chronic plaque psoriasis (Ps) in adults treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
  • To treat non-infectious intermediate, posterior, and panuveitis in adults.

ISI-0009

Please see Important Safety Information, including Boxed Warning. Please see full Prescribing Information.

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