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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.
Who should consider receiving infusions of Tzield?
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:
- Genetic risk: Even without any family history of T1D, certain genes increase a person’s risk of developing T1D.
- Autoimmune activation: When the immune system begins attacking insulin-producing cells.
- Stage 1: When two or more T1D-related autoantibodies are present, but blood sugars are normal.
- Stage 2: When two or more T1D-related autoantibodies are present, and blood sugars are abnormal, but there are no other symptoms.
- Stage 3: When symptoms develop, blood sugar levels are persistently high, and insulin therapy is immediately necessary.
How does Tzield work?
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.
How do you get Tzield?
- Test positive through screening for two or more autoantibodies that indicate you are in stage 2 of T1D.
- Work with your healthcare provider (HCP) to complete the Enrollment form on the patient site or HCP site.
- To complete the Enrollment form:
– Your HCP will need to write a prescription for Tzield.
– You will need to read and sign the patient consent section of the Enrollment form.
– The form is then sent to Provention Bio as directed.
- A member of Provention Bio’s COMPASS Navigator team will call you to begin guiding you through the process of getting insurance coverage, replying to authorization requests, submitting an appeal as needed, or applying for patient assistance as needed.
- Once your coverage for Tzield is confirmed, your COMPASS Navigator will also help you manage where you will receive 14 infusions. This will vary depending on your proximity to an infusion site or your need for an in-home visit from a qualified healthcare professional.
- The COMPASS Navigator team will check in with you during and after the process.
Will Tzield be covered by health insurance?
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.”
What does it cost — and what happens if you don’t get coverage?
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.
- An individual could qualify with an annual household income up to $67,950
- A family of 2 people could qualify with an annual household income up to $91,550
- A family of 3 people could qualify with an annual household income up to $115,150
- A family of 4 people could qualify with an annual household income up to $138,750
- A family of 5 people could qualify with an annual household income up to $162,350
“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.”
What is the Tzield infusion process like?
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.
What are the side effects of Tzield?
Fortunately, side effects of Tzield appear to be rare and relatively mild.
The most common (yet still rare) side effects reported include:
- Skin rash: “The majority of rashes observed with teplizumab treatment were not serious and resolved without intervention,” explained the FDA briefing.
- Headache: The headaches are generally reported as non-serious and resolved without intervention.
- Lymphopenia: This indicates a drop in white blood cells — which is the expected result of Tzield’s impact on the immune system. This drop in white blood cells is temporary and returns to normal levels shortly after the infusions are completed. This drop in white blood cells does not prevent you from going about normal everyday life — including going to work, school, etc.
Can you go to school, work, etc., during/after receiving Tzield?
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.
Can you get another round of Tzield a year later…and beyond?
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.
Get screened for the early stages of T1D — and tell your friends, too!
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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