November 3, 2023

Washington D.C., November 3, 2023 – Breakthrough T1D is the leading global type 1 diabetes, or T1D, research and advocacy organization. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. 

T1D is an insidious autoimmune disease that strikes children and adults and is fatal without lifelong insulin therapy. Insulin affordability, particularly the cost to the person with diabetes, is a priority for our community because consistent access to insulin means life or death. Breakthrough T1D is committed to a future where everyone, regardless of insurance status, has the choice of the insulin products that work best for them and can access that insulin at an affordable cost. The continued focus by CMS on insulin affordability is critical to ensure this happens. 

While inclusion of two insulin products in the negotiation process may lower out of pocket costs for those using these products, we are concerned that the way insulin was included will create confusion among people with diabetes and potentially result in access challenges. Let me explain. The coupling of Fiasp Insulin and Novolog Insulin in the negotiation process may negatively impact access and coverage. These products have separate FDA approvals and are considered separate products by patients and health care providers because people with diabetes have different experiences and outcomes with each of these insulins.  

It is important that people with diabetes and their healthcare teams be able to choose the insulin and diabetes devices that work best for them because the evidence is clear. This choice leads to better glycemic control which reduces the incidence of short- and long-term diabetes complications. Given this importance of choice among many types of insulin, it is essential that CMS ensure the coupling of these distinct products for purposes of negotiation does not reduce access to either of these insulins, or to other insulin products, for Medicare enrollees. We encourage CMS to further clarify how Part D sponsors are to cover these insulin products while ensuring neither product is inappropriately excluded from a formulary. 

As we celebrate the 100th anniversary of the discovery of life saving insulin winning a Nobel Prize this year, we again thank CMS for its continued focus on the vital issue of insulin affordability. We stand ready to continue our work with CMS to ensure that people with T1D have affordable access to all FDA-approved insulins.