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Is a Blood Test for Type 1 Diabetes in Kids Worth the Cost?

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately €22 (about $25) per child screened, and about €7000 (~$7900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes-associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria, Germany.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the healthcare system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” says Peter Achenbach, DrMed, senior author of the study, in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published online recently in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

Two years ago, the Fr1da investigators reported that of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

Medscape asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2 to 17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said McQueen, who is assistant professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences in Aurora.

Is DKA Prevention Enough to Justify Universal Screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention — the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) — had a setback in July 2021 when the US Food and Drug Administration (FDA) declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, just this week Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost-effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.

What Will It Take to Implement Universal Screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, McQueen told Medscape.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost-effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved HbA1c persist over long-run time horizons.”

Nonetheless, McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the US until a pharmacologic intervention to forestall disease progression is available.

“Teplizumab approval could move this along…. We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes — all at the minimum cost possible.”

“A Benchmark for the Expected Implementation Cost of Screening”

Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany — assuming the same 0.31% prevalence found in Fr1da — the average cost per child was estimated at €21.73, including €9.34 for laboratory costs, €12.25 for pediatrician costs, and €0.14 for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was €7035.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said co-author Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observes.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The authors have disclosed no relevant financial relationships.

The ASK Study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

Diabetes Care. 2022;dc211648. Abstract

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.

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