Increased screening and early treatment could be exactly what is needed to drive preventative and patient-specific care for type 1 diabetes (T1D), says GlobalData. However, the leading data and analytics company highlights the difficulties being faced in the implementation of T1D screening. On one side, key opinion leaders (KOLs) in the EU and US believe that the need for greater T1D screening will only be met if a preventative treatment is approved. On the other side, the development of such therapies relies on screening for T1D.

Samisha Khangaonkar, Pharma Analyst at GlobalData, comments: “We have reached a catch-22 situation with T1D screening. While there have certainly been advances in treatments for type 2 diabetes (T2D) patients, insulin is still the only treatment that can be offered to T1D patients. New pipeline therapies can make T1D easier to manage through the preservation of beta cells, but the success of these therapies is contingent on treating an early diagnosed population, which relies on screening for T1D.”

The lack of focus on T1D screening means evidence of beta cell autoimmunity, which may be present for years before symptoms occur, is often missed in the early stages. Around 80–90% of insulin-producing beta cells are destroyed in a typical T1D patient by the time they are diagnosed with the disease. Such clear early warning signs means T1D would be a good candidate for screening – especially considering that there is no question that the prevalence of T1D is increasing. As of 2019, the number of diagnosed prevalent cases of T1D across the eight major markets* was 3.3 million. GlobalData expects that number to grow to 3.9 million by 2030 at an annual growth rate of 1.47%.

Khangaonkar continues: “T1D is a worldwide issue, and its increasing prevalence should be a concern. Currently, the US Preventive Services Task Force (USPSTF) only recommends blood glucose screening for prediabetes and type 2 diabetes (T2D) in adults. There are no blood glucose screening recommendations for children and adolescents, nor is there an antibody screening recommendation to identify early T1D across all ages.”

One issue in the US is that antibody screening panels can be quite costly and are typically not reimbursed for patients unless they meet the task force screening criteria.

Khangaonkar adds: “Payers interviewed by GlobalData noted that screening will ultimately only be reimbursed once preventative screening is incorporated into the USPSTF as a recommendation. US KOLs interviewed by GlobalData have suggested that the only thing keeping physicians from screening the population at large is that there is not an effective prevention therapy.

“Meanwhile, screening for T1D has still not become a part of routine clinical practice across the EU, and typically only occurs in children whose family members have T1D and are participating in a clinical trial. According to EU KOLs, screening will not penetrate routine clinical practice until a preventative treatment is approved.”

This Diabetes Awareness Month, the White House issued a proclamation in which they recommitted themselves to finding a cure for diabetes, and called on Congress to give Medicare the power to negotiate prescription drug prices like insulins, especially for companies that do not face competition.

Khangaonkar continued: The diabetes space is dominated by Eli Lilly, Novo Nordisk and Sanofi. This year, Viatris’ Semglee – a biosimilar of Sanofi’s long-acting insulin glargine Lantus – saw its inclusion in some formularies and this should create price competition. However, this is not nearly enough to address the impact insulin prices have on diabetes management. Further, GlobalData has forecast that insulin glargine and other long-acting insulins will decrease in use over the next 10 years as more patients switch to insulin pump treatments that use rapid insulins.”

* 8MM: the US, France, Germany, Spain, Italy, the UK, Japan and Canada