The pharmaceutical company Amgen has again sued Colorado over a state board\u2019s decision to place a price cap on the blockbuster rheumatoid arthritis drug Enbrel.<\/p>\n
The Colorado Prescription Drug Affordability Review Board placed the price cap on the drug last month<\/a> and set it at $600 for a standard weekly dose \u2014 about $31,000 per year but still almost 50% less than what patients and insurers paid for a yearly dose on average in Colorado in 2023. The board, also known as the PDAB, is one of the centerpieces of Gov. Jared Polis\u2019 approach to reducing health care costs through stronger government regulation.<\/p>\n Amgen said the price cap, which is formally called an upper payment limit, is unconstitutional and will cause the company financial damage.<\/p>\n \u201cAmgen will suffer substantial, irreparable harm as a result of Colorado\u2019s imposition of an upper payment limit on Enbrel,\u201d the company writes in its lawsuit, which was filed in U.S. District Court in Denver on Thursday. The company is represented by attorneys based in Colorado and in Washington, D.C., with the firm King & Spalding.<\/p>\n Amgen reported making<\/a> more than $3.3 billion in Enbrel sales worldwide last year. But that number has been shrinking in recent years \u2014 it was over $4 billion in 2022 \u2014 due in part to what Amgen has described in financial reports as declining net sales prices.<\/p>\n The company sued the state previously<\/a> while the PDAB studied the possibility of imposing a price cap on Enbrel. A federal judge dismissed that lawsuit in April<\/a>, saying that the company had not at that time shown it would likely suffer harm from the PDAB\u2019s actions.<\/p>\n Now that a price cap has been set, Amgen has essentially refiled the same lawsuit with a few changes.<\/p>\n The lawsuit alleges that the price cap and the process the PDAB used to set it violate the U.S. Constitution\u2019s supremacy clause and commerce clause, as well as the due process protections of the 14th Amendment. Specifically, the lawsuit claims that Colorado\u2019s price cap conflicts with federal patent authority and that the state is trying to regulate economic activity that occurs outside of Colorado. The lawsuit also alleges that the PDAB\u2019s decision-making lacked \u201cmeaningful standards,\u201d making it arbitrary.<\/p>\n Amgen did not refile a claim that the price cap interferes with Medicare\u2019s pricing authority after the PDAB clarified that its price caps do not apply to purchases by federal health programs.<\/p>\n There is one other thing that is different this time around: the judge. Amgen\u2019s first lawsuit was heard by U.S. District Court Judge Nina Y. Wang, who was appointed to the bench by President Joe Biden. This time, the case has been randomly assigned to U.S. District Court Judge Daniel D. Domenico, the only federal trial judge in Colorado to have been appointed by President Donald Trump.<\/p>\n The first hearing in the case will occur before a magistrate \u2014 a lower-level judge who often handles preliminary matters in complex civil cases. That hearing isn\u2019t scheduled until January.<\/p>\n The price cap on Enbrel isn\u2019t set to go into effect until January 2027.<\/p>\n Type of Story: News<\/p>\n Based on facts, either observed and verified directly by the reporter, or reported and verified from knowledgeable sources.<\/p>\n","protected":false},"excerpt":{"rendered":"The pharmaceutical company Amgen has again sued Colorado over a state board\u2019s decision to place a price cap…\n","protected":false},"author":3,"featured_media":357670,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[122319,210,1060,174267,174268,174269,11825,67,132,68],"class_list":{"0":"post-357669","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-colorado-division-of-insurance","9":"tag-health","10":"tag-medication","11":"tag-phrma","12":"tag-prescription-drug-affordability-board","13":"tag-prescription-drug-costs","14":"tag-prescription-drugs","15":"tag-united-states","16":"tag-unitedstates","17":"tag-us"},"share_on_mastodon":{"url":"","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/357669","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=357669"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/357669\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/357670"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=357669"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=357669"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=357669"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}