November is Diabetes Awareness Month, and a time when communities around the world bring attention to diabetes.
According to the US Centres for Disease Control and Prevention (CDC), more than one in three adults in the US have prediabetes, equivalent to 88 million people, and 84% of these individuals do not know they have it. Left untreated, either through lifestyle changes or therapeutics, this can develop into type 2 diabetes (T2D). This year’s National Diabetes Awareness Month is focusing on prediabetes and diabetes prevention, which, for the T2D population, involves regular screening.
But screening should not be unique to the T2D population. At present, patients with type 1 diabetes (T1D) are ultimately only diagnosed once symptoms of T1D occur. By the time symptoms of the disease present themselves, 80–90% of insulin-producing beta cells will have been destroyed, but evidence of beta-cell autoimmunity through the presence of autoantibodies would have been present for many years prior.
In the US, the US Preventive Services Task Force (USPSTF) recommends blood glucose screening for prediabetes and T2D in adults aged 35 to 70 years who are overweight or have obesity. There is, however, no blood glucose screening recommendation for children and adolescents, nor is there an antibody screening recommendation to identify early T1D across all ages. Antibody screening panels can be quite costly and are typically not reimbursed for patients unless they meet the task force screening criteria. Payers interviewed by GlobalData noted that screening will ultimately only be reimbursed once preventative screening is incorporated into the USPSTF as a recommendation. Key opinion leaders (KOLs) in the US interviewed by GlobalData have suggested that the only thing keeping physicians from screening the population at large is the lack of an effective prevention therapy.
This Diabetes Awareness Month, the White House has publicly recommitted itself to finding a cure for diabetes, and called on Congress to give Medicare the power to negotiate prescription drug prices like those for insulins, especially for companies that do not face competition. The diabetes space, and in particular the insulin space, is currently dominated by Eli Lilly, Novo Nordisk and Sanofi. This year, the first interchangeable biosimilar insulin (Viatris’ Semglee, a biosimilar of Sanofi’s long-acting insulin Lantus (insulin glargine)) saw its inclusion in some formularies, which should create price competition. But this is not nearly enough to address the impact insulin prices have on diabetes management, and GlobalData has forecast that insulin glargine and other long-acting insulins will decrease in use over the next ten years as more patients switch to insulin pump treatments that use rapid insulins.
Germany has many ongoing population screening studies for testing genetic risk, as well as antibody tests for children aged two to six years, so there is an increasing trend towards catching T1D patients earlier in disease progression, prior to dysglycaemia. While earlier diagnosis is possible, 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 thus participating in a clinical trial. According to EU KOLs, screening will not penetrate routine clinical practice until a preventative treatment is approved.
It is the 100-year anniversary of the discovery of insulin, which saw the first successful treatments in a dog with diabetes in November 1921. While there have certainly been advances in treatments for T2D patients, insulin is still the only treatment that can be offered to T1D patients. Newer pipeline therapies in development can, however, make T1D easier to manage through the preservation of beta cells. The success of these therapies is contingent on treating an early-diagnosed population, which will require screening for T1D.
There is no question that the prevalence of T1D is increasing. In 2019, the diagnosed prevalent cases of T1D across the eight major markets (the US, France, Germany, Spain, Italy, the UK, Japan and Canada) were 3,307,351, and GlobalData expects this number to grow to 3,886,096 by 2030 at an annual growth rate of 1.47%. Increased screening and early treatments could be exactly what patients need to drive preventative and patient-specific care in T1D.