Enbrel drugmaker Amgen sues over Colorado’s potential price cap

A drugmaker whose product might be the primary subjected to a value cap in Colorado is suing to throw out the state board that deemed its treatment unaffordable.

In February, the Colorado Prescription Drug Affordability Board dominated the arthritis drug Enbrel was unaffordable for sufferers within the state. It was the primary time any state within the nation made such a declaration, and arrange a months-long course of to find out whether or not the board ought to set a ceiling on what Colorado sufferers and pharmacies pay for that drug.

Enbrel prices sufferers and their insurers greater than $46,000 per yr, the board discovered, and it gained’t have generic competitors till a minimum of 2029. Sufferers use it for 4 varieties of arthritis and two different circumstances the place the immune system assaults the physique’s tissues.

The lawsuit, filed in U.S. District Court docket in Denver on Friday by drugmaker Amgen and two of its subsidiaries, alleges the board wasn’t solely unsuitable to search out Enbrel unaffordable, however that the Colorado regulation that created the panel is unconstitutional and ought to be overturned by the courts.

Vince Plymell, a spokesman for the Colorado Division of Insurance coverage, which oversees the board, on Monday stated the company wouldn’t touch upon the lawsuit.

The Prescription Drug Affordability Board beforehand thought of the cystic fibrosis drug Trikafta and the HIV mixture capsule Genvoya, however declared them inexpensive. It additionally will assess the autoimmune illness medicine Stelara and Cosentyx.

Amgen’s lawsuit argues that the board’s actions conflicted with federal regulation, which grants a interval when drugmakers can completely market their merchandise beneath patents at no matter value they like. The grievance additionally stated the method of declaring a drug unaffordable didn’t embody enough safeguards to make sure due course of and to guarantee that any value included an enough revenue margin for the drugmaker.

“Congress struck a deliberate stability within the pharmaceutical area — permitting those that develop revolutionary new medicine, and who might be anticipated to put money into new improvements, to learn from market exclusivity for a particular and outlined interval whereas encouraging value competitors thereafter,” the lawsuit stated.

California-based Amgen additionally alleged that the statute that created the board was written broadly sufficient that it may apply to transactions outdoors Colorado, and even the federal Medicare program. Medicare is pursuing its personal drug negotiations via a separate course of.