Kevan Herold, MD, professor of immunobiology and medicine at Yale School of Medicine, talks about some insurers' requirement for patients to have a first-degree relative with type 1 diabetes to qualify for coverage of teplizumab.
Kevan Herold, MD, professor of immunobiology and medicine at Yale School of Medicine, explains how the participant elgibility criteria from the TrialNet 10 study may have shaped insurers' decisions on teplizumab coverage for type 1 diabetes (T1D). Teplizumab is the first drug to delay the onset of T1D and received FDA approval in November 2022.
Can you describe the patient eligibility criteria in the TN-10 study and why that was important for the trial?
The patients needed to come in through our—our as in TrialNet's—Pathway to Prevention study. Now, those individuals were largely relatives, but not exclusively relatives, because if you're found to have stage 2 diabetes outside of TrialNet, you can come in. But basically, these were individuals who had been identified as being double autoantibody positive and had some dysglycemia.
The only reason that it was that way is because when TrialNet started the pathway to prevention, the screening involved screening relatives. The reason we did that is because you enrich for the number of people at risk. I mean, the reason people rob banks is that's where the money is. There's just enrichment of people who are at risk, but the majority of people who are at risk don't have a relative.
Can you expand on your comment about T1D risk among those with first-degree relatives with T1D?
The data largely comes from...it's both TrialNet data and data from other investigators around the world suggesting that if you have stage 2 diabetes, your risk of developing the disease is the same whether or not you have a relative. Overall, it's about 75% of people developing diabetes in 5 years. In fact, in the trial, the median time to developing diabetes was somewhere between 24 and 27 months, so the predictions are spot on.
What is your response to insurance companies requiring patients to have a first-degree relative with T1D to qualify for coverage?
I mean, it's a severe restriction, because most people who will develop diabetes don't have a relative; the vast majority of people don't. With the understanding that stage 2 diabetes is something that happens before you present with clinical diabetes—we call it stage 3—then you potentially would miss all these people.
I think that's a mistake they're making. I don't think that's appropriate, and I think it's not enabling people who potentially could benefit to get access to the drug. Look, where we want to go with this is we're now thinking we'd like to promote universal screening. I mean, that's what was done in Bavaria. Now that we have something to do for delay or prevention of diabetes, why don't we screen all school-aged children? I mean, we screen for a lot of things that are much less common than type 1 diabetes.
This transcript has been lightly edited for clarity.