Colorado Enbrel price cap paused as Amgen lawsuit proceeds

A federal judge has paused the Colorado Enbrel price cap, blocking the state’s drug affordability board from enforcing a $600 weekly limit while Amgen’s lawsuit proceeds. The case matters beyond one arthritis drug because it could shape whether state boards can set payment limits for costly medicines, according to Shweta Kumar, a researcher writing in The Conversation.

Colorado is among a small group of states with a prescription drug affordability review board, and one of four whose boards can set upper limits on what state agencies, insurers and other purchasers may pay or be reimbursed for certain drugs, Kumar reported. The Colorado Prescription Drug Affordability Review Board set the Enbrel cap in fall 2025, with enforcement scheduled for Jan. 1, 2027.

Enbrel, made by Amgen, is an immunosuppressant used for rheumatoid arthritis, psoriasis and other autoimmune conditions. The board’s $600-per-week limit equals about $31,200 a year, compared with about $53,000 that the average Colorado health plan paid for the drug in 2023, according to Colorado insurance department materials cited by Kumar.

Why did the court block Colorado’s Enbrel price cap?

Chief Judge Daniel D. Domenico of the U.S. District Court granted Amgen a preliminary injunction on July 1, 2026, barring enforcement of the cap for now, according to court records described by Kumar. A preliminary injunction is not a final decision, but it keeps the payment limit from taking effect while the legal challenge continues.

Amgen argues that Colorado’s cap is barred by patent preemption. Patent preemption means a state law can be invalid if it conflicts with federal patent law under the Constitution’s supremacy clause.

Federal patent law gives patent holders a limited right to exclude others from making, using or selling an invention. Amgen contends that Colorado’s limit interferes with patent law’s purpose by reducing the returns available during that patent-protected period, Kumar reported.

Domenico treated a 2007 Federal Circuit decision striking down a Washington, D.C., drug-pricing law as controlling, according to Kumar. The judge also rejected Colorado’s argument that its rule governs only downstream payments, writing that the cap would leave Amgen with less money from wholesalers and in negotiations with purchasers.

What makes Colorado’s law different?

Kumar noted that the Colorado law applies to drugs whether or not they are patented, while the Washington, D.C., law at issue in 2007 targeted patented drugs and penalized manufacturers for excessive pricing. Colorado’s system also allows manufacturers to submit information and take part in hearings before a payment limit is set.

The dispute follows an earlier Amgen lawsuit over Enbrel that was dismissed in March 2025 by Judge Nina Y. Wang, according to Kumar. In that case, the court found Amgen was not directly regulated by the law and that any harm was too speculative because no upper payment limit had been set.

Kumar wrote that the new case raises a broader question: whether a patent gives only a right to exclude competitors, or whether it also protects a company from state rules that reduce expected profits. She pointed to other rulings allowing governments to tax, ban or pressure price reductions for patented products, as well as federal courts’ rejection of pharmaceutical industry challenges to Medicare drug price negotiation.

What happens next?

Because the case arises under patent law, any appeal would go to the U.S. Court of Appeals for the Federal Circuit, the same court that decided the 2007 Washington, D.C., case, Kumar reported. If that court does not distinguish Colorado’s law or revisit its earlier reasoning, Kumar wrote, the state’s cap may depend on intervention by the Supreme Court.

Other states are watching. Maryland, Washington and Minnesota have their own affordability review boards, and Maryland has already agreed to cap prices for Ozempic and Jardiance, according to Kumar. The outcome could determine whether those boards can do more than study drug prices and recommend policy changes.

This story draws on original reporting from Medical Xpress.