Amgen’s arthritis blockbuster Enbrel already owns an undesirable spot on the list of 10 drugs eligible for the first round of Medicare pricing negotiations. Now, the company is fighting back against a move in Colorado that aims to cap the med’s price at the state level.
In a recently filed lawsuit in Colorado federal court, Amgen is challenging a vote from the state’s newly created Prescription Drug Affordability Review Board. The board plans to subject the drug to an “upper payment limit,” local newspaper the Colorado Sun reports.
The board has deemed Enbrel’s price to be “unfavorable." But in its complaint (PDF), Amgen called the board's determination an “unconstitutional” violation of due process and federal law.
The panel of five governor-appointed members was formed through a state act. It initially selected 604 meds to review in June, then narrowed the list to just five drugs in August.
Only three of the panel members were present at the February final vote to select Enbrel for upper payment limits. The vote will result in a 180-day rulemaking process to land on the specific amount of the limit.
Then, the new price regulation would take effect six months following that ruling.
Amgen claims the process violates the U.S. Constitution in four ways. For one, the board’s governance does not exclude patented drugs, which the company says steps on patent laws by taking away the incentives that come with patent protection. Enbrel’s patents protect it from biosimilar competition through 2029.
Plus, the act that created the board is at odds with the Fourteenth Amendment’s due process clause, Amgen says. That's because there's no listed standard that must be applied when setting an upper payment limit.
The company’s third and fourth complaints concern the applicability of payment limits to federal payers and transactions that occur outside of the state.
All in all, Amgen has “significant concerns with the Colorado Prescription Drug Affordability Board’s decision to move forward with its flawed policy and process,” a spokesperson said in an emailed statement, adding that there "is no legal basis for the Board’s actions or haphazard process throughout the review period.”
Amgen set Enbrel’s list price at $1,762.34 per 50 mg dose, meaning a full year of treatment for some patients could come out to more than $90,000 before any rebates or discounts. The company reported $3.65 billion in 2023 sales of the med, a 10% decline from 2022.
As for the Medicare pricing negotiations under the Inflation Reduction Act, Amgen recently submitted a counteroffer to the government’s initial pricing offer on Enbrel. Once the back-and-forth wraps up in August, the prices will be published in September and take effect in 2026.