Drug company Amgen sues Colorado over price-fixing prescription drug board

Amgen, the multinational pharmaceutical company that makes the arthritis drug Enbrel, has sued Colorado over state boards’ efforts to cap the drug’s price.

In a lawsuit filed Friday in U.S. District Court in Denver, Amgen argues that the Colorado Prescription Drug Affordability Board’s actions are unconstitutional because they conflict with federal laws and because they violate due process rights . The company is seeking not only to overturn the boards’ recent decisions on Enbrel, but also to repeal major parts of the law creating the board.

We have significant concerns with the Colorado Prescription Drug Affordability Board’s decision to move forward with its flawed policy and process, Amgen said in a statement. There is no legal basis for the actions of the Boards or for the casual process during the review period.

A spokesman for the Colorado Division of Insurance, which hosts the affordability board, said they could not comment on pending litigation.

Colorado lawmakers, backed by Gov. Jared Polis, created the Prescription Drug Affordability Board, or PDAB, in 2021 with the goal of reducing prescription costs. The board has the ability, after extensive review, to set so-called upper payment limits, basically price caps for drugs it deems unaffordable.

Its first prescription drug reviews prompted outcry from patient groups worried that price caps would cause their needed drugs to be pulled from the Colorado market. But last month, the board voted unanimously to declare Enbrel unaffordable, setting in motion a roughly six-month process to assess whether it would become the first state to put a price cap on a prescription drug.

Enbrel is an injectable drug used to treat rheumatoid arthritis and other conditions. According to Amgen, its list price is $1,762.34 per 50 mg dose, meaning a full year of treatment for some patients could top $90,000. But Amgens’ patient assistance programs mean that almost no patient pays the list price out of pocket. Insurance companies pick up the vast majority of the bill, even for patients who don’t receive financial aid.

Amgen reported that it earned about $3.7 billion from worldwide sales of Enbrel in fiscal 2023, down 10% from a year earlier.

In its lawsuit, Amgen argues that Colorado’s PDAB law violates the Supremacy Clause of the US Constitution by seeking to override federal patent laws.

To incentivize the immense risk-taking and investment required to discover and develop new medical treatments, Congress has established a carefully calibrated intellectual property regime that rewards pharmaceutical innovation with a period of market exclusivity and the ability to charge prices that allow more investment and innovation. during that period, the lawsuit says.

Amgen says the law could also interfere with Medicare’s ability to control its pricing decisions. And the company also argues that the law seeks to regulate transactions that occur outside of Colorado in violation of the Constitutions Commerce Clause.

Finally, Amgen argues that the Colorado law is too vague and leaves too much fine print for the PDAB to decide, creating due process violations. That doesn’t give drugmakers a meaningful opportunity to be heard and doesn’t protect them from wrongful deprivations of their property, the suit claims.

The lawsuit has been assigned to U.S. District Court Judge Nina Y. Wang, who was appointed to the bench by President Joe Biden in 2022. Amgen is asking Wang to overturn the PDAB’s authority because deals with patented drugs, federal health care programs and -State transactions. It also seeks an order preventing the PDAB from enforcing its decisions on Enbrel.

The state has not yet filed a response to the lawsuit.

Priya Telang, a spokeswoman for the Colorado Consumer Health Initiative, which supported the creation of the PDAB, called the lawsuit “unfortunately expected.”

“It is a known practice that drug companies demand to protect profits and excessive prices,” Telang wrote in an email. “In this case, it’s just another example of those benefits over patients, regardless of the harmful impact that high-cost drugs have on those patients.”


United States District Court: look Amgen v. Colorado Prescription Drug Affordability Review Board. Source Link

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