Insulin has long been unaffordable for many people in the United States, even though the cost to produce most insulin vials remains between $3 and $6. Over the past few decades, prices have skyrocketed, with “the Big Three” insulin manufacturers, Eli Lilly, Novo Nordisk, and Sanofi, controlling nearly all of the U.S. insulin market and raising prices in lockstep. Thanks to persistent advocacy and legal action, we have won a significant victory in holding intermediaries accountable for practices that drove up insulin costs.

Since the 1990s, insulin prices in the U.S. have increased by more than 1200%, while production costs have stayed low. The January 2021 Grassley/Wyden report stated that insulin manufacturers “lit the fuse on skyrocketing prices by matching each other’s price increases step for step rather than competing to lower them.” This hyper-consolidation and anti-competitive behavior disproportionately affected low-income and minority Americans.

To address this, T1International partnered with the American Economic Liberties Project (AELP) in 2021 to launch the “Investigate Insulin Now” campaign. We called on the Federal Trade Commission (FTC) to open a formal investigation into the insulin manufacturers.

Our advocacy began with a complaint letter backed by petition signatures in March 2021. We engaged media, collected public comments, and submitted both written and video testimonies to the FTC hearing in September 2021. By April 2022, the FTC was seeking public input on how pharmacy benefit managers (PBMs) affect drug affordability. This meant that the investigation shifted from just manufacturers to instead intermediaries, but by 2023, the FTC had launched a non-public investigation into both insulin manufacturers and intermediaries, which led to enforcement action in the summer of 2024.

The FTC lawsuit targeted the three major PBMs in the U.S.: CVS Caremark, Express Scripts, and OptumRx, and their affiliated PBM Group Purchasing Organization (GPO). A GPO is different from a PBM because a PBM negotiates with drug manufacturers for insurers while a GPO aggregates purchasing power to negotiate discounts outside of just drugs for more than just insurances; for example, products and services for hospitals and clinics. The complaint alleged these intermediaries engaged in anticompetitive and unfair rebating practices, which inflated insulin prices, limited access to cheaper alternatives, and shifted costs to patients who rely on insulin to survive. While the lawsuit did not directly pursue antitrust action against the Big Three insulin manufacturers, it focused on how the intermediaries manipulated the system to drive up costs.

In December 2024, T1International received a subpoena for the case due to our previous engagement. With pro bono legal support from ZwillGen, we were able to fully comply.

The major victory came in February 2026, when the FTC reached a settlement with Express Scripts. The settlement requires the company to change its business practices, increase transparency, and save patients up to $7 billion on out-of-pocket drug costs over ten years. Notably, the company’s stock price was unaffected, signaling that this change prioritizes patient access without harming corporate profitability.

While this settlement is significant, there is still room for improvement. Some formulary restrictions and copay caps do not cover all patients or all insulin types. T1International and AELP submitted detailed recommendations to the FTC to expand coverage and ensure broader patient impact. The cases against Caremark and Optum are ongoing, and several state and institutional investigations into insulin pricing remain active.

“The FTC settlement proves that accountability works when advocates push for it,” said Kristen, T1International’s Federal Working Group Co-lead. “This settlement is a major step toward making insulin accessible for everyone who needs it.”

More work remains, including settlement of the other two intermediaries named in the case. And this case sets a precedent for future efforts to increase competition in the market and reign in drug prices.

Insulin affordability in the U.S. has long been a crisis, but this victory demonstrates that change is possible. Together, advocacy groups, allies, and regulators can ensure that lifesaving medicines are available to the people who need them most.