Today, the American Diabetes Association® (ADA) released its “ADA Public Policy Statement: Insulin Access and Affordability,” (Public Policy Statement) outlining both long- and short-term recommendations for improving insulin affordability. The ADA’s recommendations include increasing transparency across the entire insulin supply chain; streamlining the approval process for biosimilar insulins; lowering or removing patient cost-sharing for insulin; and increasing access to health-care coverage for all people with diabetes. The Public Policy Statement follows the “Insulin Access and Affordability Working Group: Conclusions and Recommendations,” white paper (White Paper), published May 8, 2018 in Diabetes Care. The ADA’s Chief Scientific, Medical, & Mission Officer William T. Cefalu, MD, testified on May 8, 2018, before the United States Senate’s Special Committee on Aging to share the findings and conclusions of the White Paper.

More than 30 million Americans have diabetes, and approximately 7.5 million of them rely on life-sustaining insulin, including more than 1.5 million individuals with type 1 diabetes. Insulin is a matter of life and death; there is no alternative medication that can be substituted for insulin. Of great concern to the ADA is the recent surge in insulin prices—the average price of insulin nearly tripled between 2002 and 2013. The rising cost of and access to insulin ultimately impacts everyone, particularly people with diabetes and their families, health-care providers, insurers, and employers. Current estimates demonstrate that diabetes is the most expensive chronic illness in the US, with diagnosed diabetes costing more than $327 billion in 2017, including $15 billion for insulin.

“The ADA is steadfast in our commitment to ensure every individual who needs insulin has affordable access to this critical, life-sustaining medication,” said Dr. Cefalu. “We’ve incorporated our previous work with the conclusions and recommendations from our expert Working Group to present a full slate of public policy options, and we look forward to continued dialogue with all stakeholders in the insulin supply chain to implement viable, long-term solutions to this important and expensive issue that ultimately affects us all.”

A recent survey by the ADA also confirmed that individuals who face high out-of-pocket costs for insulin are not adhering to their diabetes care plan by either rationing or forgoing insulin doses to reduce costs. Insulin is critical to maintaining appropriate blood glucose levels and reducing the risk of serious complications, such as cardiovascular disease, blindness, kidney disease, amputation, and death. When insulin is not taken appropriately, the risk of complications increases.

The Public Policy Statement is the latest milestone in the ADA’s Make Insulin Affordable strategic initiative, which launched in November 2016, and includes a petition that has been signed by nearly 350,000 individuals, to date. The Insulin Access and Affordability Working Group (Working Group) was convened by the ADA’s Board of Directors in the spring of 2017. The Working Group’s findings, as detailed in the White Paper, confirmed there is a lack of transparency throughout the insulin supply chain, making it difficult to fully understand each entity’s profits or their ability to impact the final cost. The White Paper addressed other important factors impacting insulin costs, including the regulatory framework for developing biosimilar insulins, prescribing patterns of providers, and the role of formulary decisions in determining which medications, including insulin, are covered and at what out-of-pocket cost to the individual.

“The ADA has been advocating for improved access to affordable and quality health care for years,” said LaShawn McIver, MD, MPH, Senior Vice President of Government Affairs, Advocacy, & Community Integrated Health at the ADA. “We look forward to continuing to work with policy makers to help us achieve the necessary changes that will reduce the financial burden, improve health outcomes, and protect our nation’s most vulnerable populations from dangerously high insulin costs. It’s a matter of life and death.”