Celltrion CONNECT Patient Assistance Program: ZYMFENTRA™ (infliximab-dyyb) Definition, Rules and Eligibility, and Terms and Conditions

1. Description

  1. 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 CARES™ 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 ZYMFENTRA™ (infliximab-dyyb) and its reference/generic/biosimilar.
    2. This program excludes patients whose medication is reimbursed in whole or in part by any type of government insurance (e.g., Medicare, Medicaid, TRICARE, or any other federal or state program). Patients who have Medicare A&B only (no Medicare Part D) are still excluded.
      1. Patient must have a valid prescription from a licensed healthcare provider (HCP) for an on-label indication.
      2. Patient must have an adjusted annual household income of ≤500% of the federal poverty level (FPL).
      3. Income verification:
        1. Electronic income verification (eIV) will be conducted by the program. No asset review will be required; however, patients will need to provide proof of income if eIV does not match what the patient has reported (proof of income could include one of the following: W-2s, tax returns (1040, 1099), 3 months of paystubs).
      4. Patient must show proof of residency by providing valid United States or the Commonwealth of Puerto Rico address and product must be administered and shipped to locations in the United States or the Commonwealth of Puerto Rico. Patient must have lived in the United States or the Commonwealth of Puerto Rico for at least 6 months.
      5. Diagnosis and dosing are consistent with FDA-approved indication for ZYMFENTRA.
      6. Patients with insurance plans or employers participating in an alternate funding program (also sometimes referred to as patient advocacy programs, specialty networks, SHARx, Paydhealth, or PayerMatrix, among other names) are not eligible for PAP.
        1. These programs require patients to apply to a manufacturer’s PAP or otherwise pursue specialty drug prescription coverage through an alternate funding vendor as a condition of, requirement for, or prerequisite to coverage of relevant products, or that otherwise denies, restricts, eliminates, delays, alters, or withholds any insurance benefits or coverage contingent upon application to, or denial of eligibility for, specialty drug prescription coverage through the alternate funding program.
        2. Patients must promptly contact the Celltrion CONNECT® PAP if their financial status or insurance coverage changes.
      7. Electronic benefits verification (eBV) will be conducted by the program every 6 months to determine coverage changes.
      8. Program enrollment period is a rolling 12-month period from the date of eligibility in which they have been approved.