Judge throws out lawsuit challenging Colorado’s ability to cap prices on prescription drugs

A federal judge threw out Amgen’s lawsuit against the state board empowered to set first-in-the-nation price ceilings on prescription drugs in Colorado, finding that the maker of arthritis medication Enbrel hadn’t proven it would suffer any harm.

Colorado’s Prescription Drug Affordability Board can declare medications “unaffordable” and set an “upper payment limit,” which is the maximum amount that patients, their insurers or pharmacies could pay for a specific medication sold in the state.

U.S. District Judge Nina Y. Wang ruled Friday that a price ceiling set by Colorado wouldn’t limit what Amgen could charge for its drugs, because the company would go through wholesalers and possibly other middlemen before reaching pharmacies in the state.

Amgen sued the board in March 2024, after it declared Enbrel unaffordable for Colorado patients. The drugmaker argued not only that the board’s decision was wrong, but that the law setting up the board was unconstitutional.

Enbrel can cost patients and their insurance companies more than $46,000 per year, though patients with private insurance or Medicare Advantage paid an average of about $2,300 out-of-pocket as of 2022. The U.S. Food and Drug Administration has approved it for four types of arthritis and two other conditions where the immune system attacks the body.

A price ceiling at the patient and pharmacy level likely would decrease “upstream” prices, Wang wrote in the 19-page ruling, but California-based Amgen hasn’t proven it would suffer any loss, since the ceiling could be above what the company currently charges wholesalers.

The state’s Prescription Drug Affordability Board won’t begin the price-setting process until mid-April, and could opt not to establish a ceiling.

Amgen hasn’t said if it would refuse to sell Enbrel at a lower price in Colorado, though its statements have referenced potential problems with access to the drug. Supporters of the affordability board have argued the company is bluffing to protect its revenues, but no one will know until the board sets a price and Amgen responds.

Colorado is the first state to attempt to set a price ceiling on any drug.

A statement from Amgen said the company continues to have “significant concerns” about the possibility of a price ceiling.

“Not only is the law unconstitutional, but price controls will not meaningfully address affordability at the pharmacy counter and will instead create new access barriers for many patients,” the company said.

The Colorado Division of Insurance, which oversees the affordability board, declined to comment.

The lawsuit’s end will allow the board to move forward with setting an upper payment limit, said Isabel Cruz, policy director of the Colorado Consumer Health Initiative. Enbrel’s sticker price, before rebates, has risen more than 1,500% since 1998, she said.

“We look forward to the board’s continued efforts to meaningfully address the harms that the high cost of drugs like Enbrel have on patients. Drugs don’t work if people can’t afford them,” she said in a statement.

The board considered four other drugs in its first year. It also declared Cosentyx and Stelara, both of which have FDA approval for conditions where the immune system attacks other tissues, to be unaffordable. It deemed the cystic fibrosis drug Trikafta and the HIV drug Genvoya affordable despite high sticker prices, because patients reported insurance and discount programs kept their costs down.

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