On November 17, 2022, the FDA approved a new drug that can delay the full onset of type 1 diabetes (T1D). Tzield (teplizumab) — developed by Provention Bio — is truly a “breakthrough therapy” and a huge step forward in the research to prevent and cure T1D.
Here’s a closer look at the actual process of getting and receiving infusions of Tzield to delay the full onset of T1D.
Tzield is currently only approved for use in people ages 8 years and older who test positive for stage 2 of T1D. Decades of research have pinpointed the stages of T1D as:
Getting tested for these early stages of T1D can be done at home or in a clinic/laboratory setting.
Delivered intravenously, Tzield works by essentially pressing “pause” on the autoimmune attack on the cells that produce insulin. It also increases the number of cells that help your immune system function properly.
Research on Tzield has shown it can delay the full onset of T1D by an average of two years — but some participants didn’t develop the disease for seven years after receiving treatment.
Like any new drug, getting health insurance coverage may take extra effort and paperwork, but Provention Bio has developed a team of experts to help any individual or family navigate this process.
The “COMPASS Navigator” team will support anyone prescribed Tzield through every step of getting coverage, submitting a prior authorization or appeal, and applying for patient assistance if necessary.
“Every situation can be so different and unique,” explained representatives from Provention Bio, “but we want everyone to have access to Tzield. We can’t guarantee it, of course, but we’ll do everything we can to help families get access. Our COMPASS Navigator team will do everything possible to take the burden of financial coverage off the patient and their family.”
If you have private/commercial health insurance: Infusions of Tzield can cost as little as $0.
If you don’t have insurance/are denied insurance coverage/have high out-of-pocket costs: Any U.S. resident can apply for the Patient Assistance Program (PAP), which is comparable with PAPs for other specialty drugs. The qualification for a PAP is that your household income is at or below 500% of the federal poverty level.
For example:
“Every situation can be so different and unique,” explained representatives from Provention Bio. “We want to help everyone who needs it get access to Tzield.”
Infusions of Tzield take place once a day over the course of 14 days. Yes, this is a significant time commitment for the family of a person receiving Tzield.
The infusion itself can take as little as 30 minutes, but the entire process — from set-up to post-infusion monitoring — will take approximately two hours.
Tzield’s COMPASS Navigator team will have already helped determine and establish where you would receive infusions based on your proximity to an infusion site or your health insurance’s willingness to cover a nurse performing infusions in your home.
Ideally, these 14 days of infusions take place consecutively without skipping a day. If you miss an infusion of Tzield during the intended 14-day period, Provention Bio representatives explained that you can simply add an additional day to the schedule to make up for the missed infusion.
Fortunately, side effects of Tzield appear to be rare and relatively mild.
The most common (yet still rare) side effects reported include:
Yes — you can expect to go about your normal life during and after receiving infusions of Tzield. There is no increase in infections or illness in those who’ve received infusions of Tzield.
If one round of Tzield has the potential to delay the full onset of T1D for a couple of years, why not receive another round a year later? And the year after that?
Tzield is still undergoing research to determine if additional infusions could further delay the full onset of T1D.
“We don’t know yet,” explained representatives from Provention Bio — but the full efficacy of Tzield is being explored.
For example, the PROTECT study is also looking at giving Tzield to people diagnosed with T1D within the past six weeks. This study is fully enrolled, and the results have not yet been published.
Further research will also determine the safety and efficacy of Tzield in people under age 8 with the hope of being able to delay T1D in young children.
Did you know that nearly 90 percent of people diagnosed with T1D have no family history of the disease? This means anyone and everyone should consider getting screened — especially children and adolescents. Read more about screening your children for T1D here and here.
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