Enbrel drugmaker sues over Colorado's potential price cap, says prescription drug board is unconstitutional

DENVER — A drugmaker whose product could be the first subjected to a price cap in Colorado is suing to throw out the state board that deemed its medication unaffordable.

In February, the Colorado Prescription Drug Affordability Board ruled the arthritis drug Enbrel was unaffordable for patients in the state. It was the first time any state in the country made such a declaration, and set up a months-long process to determine whether the board should set a ceiling on what Colorado patients and pharmacies pay for that drug.

Enbrel costs patients and their insurers more than $46,000 per year, the board found, and it won’t have generic competition until at least 2029. Patients use it for four types of arthritis and two other conditions where the immune system attacks the body’s tissues.

The lawsuit, filed in U.S. District Court in Denver on Friday by drugmaker Amgen and two of its subsidiaries, alleges the board wasn’t only wrong to find Enbrel unaffordable, but that the Colorado law that created the panel is unconstitutional and should be overturned by the courts.

Vince Plymell, a spokesman for the Colorado Division of Insurance, which oversees the board, on Monday said the agency would not comment on the lawsuit.

The Prescription Drug Affordability Board previously considered the cystic fibrosis drug Trikafta and the HIV combination pill Genvoya, but declared them affordable. It also will assess the autoimmune disease drugs Stelara and Cosentyx.

Amgen’s lawsuit argues that the board’s actions conflicted with federal law, which grants a period when drugmakers can exclusively market their products under patents at whatever price they like. The complaint also said the process of declaring a drug unaffordable didn’t include sufficient safeguards to ensure due process and to make sure that any price included an adequate profit margin for the drugmaker.

“Congress struck a deliberate balance in the pharmaceutical arena — allowing those who develop innovative new drugs, and who can be expected to invest in new innovations, to benefit from market exclusivity for a specific and defined period while encouraging price competition thereafter,” the lawsuit said.

California-based Amgen also alleged that the statute that created the board was written broadly enough that it could apply to transactions outside Colorado, or even the federal Medicare program. Medicare is pursuing its own drug negotiations through a separate process.

“Colorado may not directly regulate a sale that occurs in another state simply because the product may eventually make its way into Colorado,” the lawsuit said.

Priya Telang, communications manager for the Colorado Consumer Health Initiative, said the group’s staff is still examining the lawsuit, but had expected Amgen to file one in the months after the board chose to consider a payment limit for Enbrel.

“It’s a well-known tactic to protect their products and excessive profits,” she said.