Senators Introduce Bill to Establish Insulin Cap for Commercial Plans

The Improving Needed Safeguard for Users of Lifesaving Insulin Now (INSULIN) Act of 2023, a bipartisan bill that would expand a $35 out-of-pocket (OOP) cap for insulin products for Medicare to the commercial sector, was introduced to the US Senate last week.

Diabetes affects more than 37 million Americans and is one of the most expensive chronic conditions in the nation, costing America a combined total of $327 billion annually. Additionally, a report from the Health Care Cost Institute found that nearly 9% of patients with private insurance paid an average of $403 per month for their insulin in 2019.

High insulin costs have resulted in many patients with diabetes rationing their insulin or stopping treatment, which can lead to devasting health consequences, including nerve and vision damage, amputations, and kidney and cardiovascular disease.

A $35 OOP cap for Medicare Part D plans was originally established in the Inflation Reduction Act (IRA). However, the provision for the cap to apply to commercial plans was eliminated from the IRA in order for it to pass through the Senate and become law.

During his first State of the Union address in March 2022, President Joe Biden urged congressional leaders to “cap the cost of insulin at $35 a month so everyone can afford it.” Biden had originally intended to have the measure passed as part of his Build Back Better initiative but it was removed from that bill as well.

The INSULIN Act was cosponsored by Senators Susan Collins (R, Maine) and Jeanne Shaheen (D, New Hampshire), cochairs of the Senate Diabetes Caucus. The bill would include all FDA-approved insulin products, including biosimilar insulins (Semglee, Rezvoglar) and authorized generic insulins (Lyumjev, Basaglar), which are not officially classified as biosimilars in the United States.

“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 Collins and Shaheen in a joint statement.

The news comes after major players in the insulin space—namely Eli Lilly and Company, Novo Nordisk, and Sanofi—announced that they will lower the OOP costs of their respective insulin drugs to $35. Additionally, a report from HHS revealed that if the IRA had been implemented in 2020 rather than in 2022, beneficiaries enrolled in Part D plans could have saved a total of $734 million, averaging to about $500 per member.

“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….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,” commented Lisa Murdok, chief advocacy officer at the ADA.

The INSULIN Act has 3 main objectives:

• Require group and individual market health plans to waive any deductible and limit cost sharing to no more than $35 or 25% of list price per month for at least 1 insulin of each type and dosage form
• Mandate pharmacy benefit managers (PBMs) to pass through 100% of insulin rebates and other discounts received from manufacturers to plan sponsors to reduce incentives that encourage high list prices
• Promote generic and biosimilar competition to lower costs to patients by creating an expedited approval pathway, ensuring adequate oversight of the FDA citizen petition process, allowing Medicare Part D plans to place biosimilars on formulary immediately after market entry, and requiring a report to Congress on issues and market dynamics delaying or restricting biosimilar competition

The act would also prohibit PBMs from placing utilization management tools, such as prior authorization and step therapy requirements, on products with capped OOP costs.