Senators Shaheen, Collins Introduce Bipartisan INSULIN Act to Cut Insulin Costs for Millions More Americans

**Shaheen-Collins legislation follows their initial announcement to release legislation that would comprehensively address the soaring costs of the lifesaving drug, and it is supported by leading diabetes advocacy organizations.**

**Shaheen and Collins co-chair the Senate Diabetes Caucus and have led legislation to address insulin costs & invest in diabetes research for more than a decade.**

(Washington, DC) – U.S. Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME), co-chairs of the Senate Diabetes Caucus, introduced their bipartisan legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023, on Thursday, which would comprehensively address the skyrocketing costs of insulin, removing barriers to care and making it more accessible for millions more Americans.

The INSULIN Act would directly address the root problems in the insulin market causing high list prices, while simultaneously extending vital patient protections, fostering competition and broadening access to needed insulin products.

“Access to insulin is a financial burden for many Americans who rely on it to survive. Keeping this medication within their reach is literally a matter of life and death, which is why we’ve long led action in the U.S. Senate to cut costs and why we’re redoubling our efforts through the INSULIN Act to comprehensively address the scope of this problem,” said Shaheen and Collins. “We are encouraged by the proactive steps taken by private companies, but that is a drop in the bucket on action that is needed to lower prices across the board and keep them there. Our legislation would address structural issues in the insulin market, create policies to foster more competition and expand access to insulin medications. This bill is the product of continued negotiations, with input from advocates, lawmakers and experts. Americans living with diabetes and the ones who love them cannot wait any longer for Congress to act – the time is now. We are calling on Senate leadership to bring this bill to the floor for consideration as swiftly as possible. Democrats and Republicans both want to address this problem and our legislation presents the best option for the Senate to make good on that commitment.”

“The American Diabetes Association (ADA) has been the leading advocate for limiting cost-sharing for insulin, and we are proud to endorse the bipartisan INSULIN Act,” said Lisa Murdock, Chief Advocacy Officer at the ADA. “This legislation takes important steps to immediately improve access and reduce costs for patients. While also getting to the root of the problem by making sure rebates stop inflating the price of insulin, biosimilar insulins can come to market more quickly, which will allow insurers to make these more affordable options available to patients. The ADA urges Congress to act right away to pass the INSULIN Act.”

“JDRF is thankful that Senators Jeanne Shaheen and Susan Collins are continuing their bipartisan fight to make insulin more affordable for the millions of Americans who need it to survive. Their bill, the INSULIN ACT, contains several provisions that JDRF has supported for years. JDRF supports this legislation and encourages all members of the Senate to support it as well,” said Aaron J. Kowalski, Ph.D, JDRF Chief Executive Officer.

“People with type 1 diabetes depend on insulin to stay alive since their bodies cannot produce this hormone. Privately-insured individuals with diabetes cannot wait any longer for Congress to take action to address their insulin costs,” said Joshua J. Joseph, M.D., M.P.H., Endocrine Society Clinical Affairs Core Committee Chair. “We are pleased to endorse this comprehensive legislation, which will make insulin more affordable for those who rely on it.”

More than 37 million Americans live with diabetes, including an estimated one in every three seniors. The disease is one of the leading causes of death in the United States, claiming over 100,000 lives in 2021. It is also one of the most expensive chronic conditions in the nation, costing Americans a combined total of $327 billion per year. The rising cost of insulin presents a barrier to care for a number of Americans living with diabetes. Out-of-pocket costs increase with list prices, and for people without insurance, the costs are too often untenable. According to the Health Care Cost Institute, nearly 9 percent of patients with private insurance paid an average of $403 per month for their insulin in 2019.

The INSULIN Act of 2023 would:

1. Limit out-of-pocket costs for patients with diabetes by ensuring that group and individual market health plans must waive any deductible and limit cost-sharing to no more than $35 or 25% of list price per month for at least one insulin of each type and dosage form. 
1. Pharmacy benefit managers (PBMs) would be prohibited from placing utilization management tools – prior authorization, step therapy, etc. – on products with capped out-of-pocket costs.
2. Mandate PBMs pass through 100% of insulin rebates and other discounts received from manufacturers to plan sponsors, reducing perverse incentives in the insulin market that encourage high list prices and helping patients in the form of reduced premiums.  
3. Promote generic and biosimilar competition to lower costs to patients by: 
1. Creating a new expedited FDA approval pathway for biologic drugs lacking adequate biosimilar competition, similar to FDA’s current Competitive Generic Therapies pathway. This will improve the timeliness of resolving regulatory barriers slowing down market entry of lower cost products; 
2. Ensuring adequate oversight of the Food and Drug Administration’s (FDA) citizen petition process, easing approval of generic and biosimilar drugs;
3. Allowing Medicare Part D plans to place biosimilar drugs on formulary immediately after entering the market, identical to other generic drugs; and, 
4. Requiring a report to Congress on issues and market dynamics delaying or restricting biosimilar insulin competition.

Bill text of the INSULIN Act is available here.

As co-chairs of the Senate Diabetes Caucus, Shaheen and Collins have led action in the U.S. Senate to advance priorities that will lower the costs of insulin, invest in treatment and prioritize diabetes research.  They have consistently held insulin manufacturers, insurers and pharmacy benefit managers accountable for the skyrocketing cost of life-saving insulin. Last month, Shaheen and Collins commended drug manufacturers Lilly, Novo Nordisk and Sanofi’s actions to lower their list prices for their insulin products.

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