Celltrion CONNECT Patient Assistance Program:
YUFLYMA Definition, Rules and Eligibility, and Terms and Conditions

1. Description

The Celltrion CONNECT® Patient Assistance Program (PAP) is designed to provide free product to qualified individuals who are uninsured or are functionally uninsured, who have no applicable drug coverage, or who express financial hardship affording their medication. Celltrion CONNECT® will help activate PAP for eligible participants.

2. Eligibility Criteria

Patient Assistance Program eligibility: To receive PAP benefits, the patient must enroll in the program and meet the following eligibility requirements:

  1. Patient has no insurance or who is functionally uninsured:
    1. Patients who do not have insurance (uninsured) or are insured, but product is not covered by their plan (Patient is responsible for 100% of product cost) (functionally uninsured).
      1. Functionally uninsured includes all payor types:
        1. For commercial patients who have exhausted their co-pay benefits through Celltrion CARESTM Co-pay Assistance Program.
      2. In order to be considered functionally uninsured:
        1. The patient has pharmacy benefits but the payor/pharmacy benefit manager (PBM) will not approve or pay for either the entirety or any portion of the medication.
          1. The payor/PBM must deny one level of appeal of an initial coverage denial.
        2. The patient is uninsured or their insurance plan excludes YUFLYMA® (adalimumab-aaty) and its reference/generic/biosimilar.
    2. Medicare Part D patients with coverage for YUFLYMA who cannot afford their out-of-pocket costs may be eligible. It is required that the patient is able to demonstrate:
      1. Inability to afford the medicine.
      2. Ineligibility for Medicaid or Medicare’s low-income subsidy (extra help).
      3. Satisfied all payer guidelines and prior authorization (PA) requirements prior to applying for assistance.
      4. Does not have any other financial support options.
  2. Patient must have a valid prescription from a licensed healthcare provider (HCP) for an on-label indication.
  3. Patient must have an adjusted annual household income of ≤500% of the federal poverty level (FPL).
  4. Income verification:
    1. If the electronic income check fails or the patient has not provided consent for income credit check, then Celltrion CONNECT® will request income documentation from the patient.
    2. Income documentation accepted includes tax returns (1040, 1099), W-2s, 30 days of pay stubs, unemployment letters and unemployment government assistance, if applicable. Social Security statements or Social Security verification letter.
  5. Patient must reside in the United States or the Commonwealth of Puerto Rico for at least 6 months and product must be administered and shipped to locations in the United States or the Commonwealth of Puerto Rico.
  6. Diagnosis and dosing are consistent with FDA-approved indication for YUFLYMA.
  7. Patient must not have any other financial support options. Patient has exhausted alternative funding or has confirmed no funds are available.
    1. Patients must promptly contact the Celltrion CONNECT® PAP if their financial status or insurance coverage changes.
  8. If the patient is approved through PAP, they must remain in PAP and receive free drug through the Celltrion CONNECT® PAP until the end of the calendar year that they were approved for. For example, if the patient was approved for PAP in July, they will remain enrolled in PAP until December 31st of the same calendar year.