Amgen on Monday called on a Colorado federal court to overturn the state drug affordability board’s decision to cap the price of Amgen’s blockbuster biologic Enbrel.
The California-based company said Colorado’s price controls are “unconstitutional for at least four reasons,” including that the state board does not provide “any meaningful standards” for determining why a price is considered unaffordable or how the state is setting an upper payment limit, which is expected this fall.
According to Colorado’s Prescription Drug Affordability Board drug pricing and payment dashboard, Enbrel is listed third on the state’s priority list with payments of over $72 million in 2021, the last year of data provided by the state. First approved by the FDA in 1998, Enbrel isn’t likely to see biosimilar competition until 2029.
The board previously voted on Feb. 16 that Enbrel was unaffordable for Colorado patients. A drug affordability report from the board said that patients with commercial insurance paid an average annual out-of-pocket cost of $3,980 in 2022. In data collected for the report, a little over 71% of patients and caregivers said the cost made it difficult to access.
Amgen, which first took the board to court in March, argued in its latest motion that manufacturers’ investments are not being considered by the state in setting the payment limit. Unlike at the state level, the newly created federal drug price negotiations under the Inflation Reduction Act do allow CMS to factor in how much companies invest in the medicines selected for negotiations.
“In fact, a fair rate of return is not even listed among the many factors the board is required to consider when determining whether a drug is ‘unaffordable’ and fixing an upper payment limit,” Amgen argued.
The board is also taking up Novartis’ Cosentyx and J&J’s Stelara for affordability reviews this year. Gilead’s Genvoya and Vertex’s Trikafta also made Colorado’s list. Maryland’s drug affordability board, however, is conducting studies on six different drugs to decide if there are affordability issues: Novo Nordisk’s diabetes drug Ozempic, AstraZeneca’s kidney disease drug Farxiga, Boehringer and Eli Lilly’s diabetes drug Jardiance, Lilly’s diabetes drug Trulicity, Sanofi and Regeneron’s Dupixent, and AbbVie’s Skyrizi.
Washington, Oregon and Minnesota also have PDABs setting upper limits on prices.
Amgen told the court that Colorado cannot legally set an “upper payment limit” for federal payors like Medicare or the Veterans Health Administration because “federal law preempts state laws that interfere with the federal government’s ability to control its own payment and coverage decisions.”