{"id":1064208,"date":"2026-07-02T17:45:29","date_gmt":"2026-07-02T17:45:29","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/1064208\/"},"modified":"2026-07-02T17:45:29","modified_gmt":"2026-07-02T17:45:29","slug":"judge-blocks-colorado-price-cap-on-the-prescription-drug-enbrel","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/1064208\/","title":{"rendered":"Judge blocks Colorado price cap on the prescription drug Enbrel"},"content":{"rendered":"<p class=\"has-drop-cap wp-block-paragraph\">A federal judge has temporarily blocked Colorado\u2019s <a href=\"https:\/\/coloradosun.com\/2025\/10\/07\/prescription-drug-affordability-board-enbrel-upl\/\" rel=\"nofollow noopener\" target=\"_blank\">first-in-the-nation price cap<\/a> on a specific prescription drug, saying that it likely runs afoul of legal precedent and federal patent law.<\/p>\n<p class=\"wp-block-paragraph\">The ruling is a blow to Gov. Jared Polis and his administration\u2019s efforts to lower drug costs through tougher regulation, and it raises questions about the ongoing operations of the state\u2019s Prescription Drug Affordability Board, the body that imposed the cap.<\/p>\n<p class=\"wp-block-paragraph\">The preliminary injunction issued Wednesday involves a price cap placed on the prescription drug Enbrel, which treats rheumatoid arthritis and other autoimmune conditions. The affordability board, which is known as the PDAB, placed a cap on that drug after determining it was unaffordable. Enbrel\u2019s wholesale cost <a href=\"https:\/\/doi.colorado.gov\/sites\/doi\/files\/documents\/Enbrel%20UPL%20graph%20packet%20%28PUBLIC%20COPY%29.pdf\" rel=\"nofollow noopener\" target=\"_blank\">is about $96,000 per patient per year<\/a>, though, after discounts and rebates, most patients and insurance companies combined pay about $58,000 per patient per year.<\/p>\n<p class=\"wp-block-paragraph\">The PDAB set the price cap, which was scheduled to go into effect in 2027, at around $31,000 per year. The pharma company Amgen, which manufactures Enbrel, sued, arguing that the cap undermines federal patent law and would cause the company economic harm.<\/p>\n<p class=\"wp-block-paragraph\">The injunction blocks the cap from taking effect while the lawsuit is debated. It was issued by Chief Judge Daniel D. Domenico of the U.S. District Court in Denver.\u00a0<\/p>\n<p class=\"wp-block-paragraph\">\u201cSince under binding Federal Circuit precedent, caps on the price of patented drugs like Enbrel are preempted by federal law, Amgen\u2019s motion must be granted,\u201d wrote Domenico, who was appointed to the bench by President Donald Trump and who <a href=\"https:\/\/www.coloradopolitics.com\/2026\/06\/24\/trumps-10th-circuit-nominee-declines-to-name-2020-election-winner-defends-immigration-decisions\/\" rel=\"nofollow noopener\" target=\"_blank\">is currently up for a promotion<\/a> to the 10th Circuit Court of Appeals.<\/p>\n<p><img loading=\"lazy\" data-recalc-dims=\"1\" decoding=\"async\" width=\"1024\" height=\"663\" data-attachment-id=\"377537\" data-permalink=\"https:\/\/coloradosun.com\/amgen\/\" data-orig-file=\"https:\/\/i0.wp.com\/newspack-coloradosun.s3.amazonaws.com\/wp-content\/uploads\/2024\/03\/AP23136569782364.jpg?fit=1024%2C663&amp;ssl=1\" data-orig-size=\"1024,663\" data-comments-opened=\"0\" data-image-meta=\"{&quot;aperture&quot;:&quot;0&quot;,&quot;credit&quot;:&quot;AP&quot;,&quot;camera&quot;:&quot;&quot;,&quot;caption&quot;:&quot;FILE - This photo shows signage outside the Amgen headquarters in Thousand Oaks, Calif on Nov. 9, 2014. Federal regulators are suing to block biotech drug developer Amgen\\u2019s more than $26 billion deal for Horizon Therapeutics. The Federal Trade Commission said Tuesday, May 16, 2023, that the deal, announced last December, would give Amgen unfair leverage to block competition for Horizon medications. (AP Photo\/Mark J. Terrill, File)&quot;,&quot;created_timestamp&quot;:&quot;1415545465&quot;,&quot;copyright&quot;:&quot;Copyright 2016 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistribu&quot;,&quot;focal_length&quot;:&quot;0&quot;,&quot;iso&quot;:&quot;0&quot;,&quot;shutter_speed&quot;:&quot;0&quot;,&quot;title&quot;:&quot;Amgen&quot;,&quot;orientation&quot;:&quot;0&quot;}\" data-image-title=\"Amgen\" data-image-description=\"\" data-image-caption=\"&lt;p&gt;This photo shows signage outside the Amgen headquarters in Thousand Oaks, Calif on Nov. 9, 2014. (AP Photo\/Mark J. Terrill, File)&lt;\/p&gt;&#10;\" data-large-file=\"https:\/\/i0.wp.com\/newspack-coloradosun.s3.amazonaws.com\/wp-content\/uploads\/2024\/03\/AP23136569782364.jpg?fit=780%2C505&amp;ssl=1\" src=\"https:\/\/www.europesays.com\/uk\/wp-content\/uploads\/2026\/07\/AP23136569782364.jpg\" alt=\"\" class=\"wp-image-377537\"  \/>This photo shows signage outside the Amgen headquarters in Thousand Oaks, Calif on Nov. 9, 2014. (AP Photo\/Mark J. Terrill, File)<\/p>\n<p class=\"wp-block-paragraph\">The precedent Domenico cited <a href=\"https:\/\/law.justia.com\/cases\/federal\/appellate-courts\/cafc\/06-1593\/06-1593o-2011-03-27.html?__cf_chl_f_tk=U1DAYTICG_SOn0XmietkYy5.wNKohxmCDZZgF9_T6DI-1782964478-1.0.1.1-uQQpMztgWiED2.H6TJgZZQkRUv3G33jy.l5lcVToDuA\" rel=\"nofollow noopener\" target=\"_blank\">involved a similar effort<\/a> by the District of Columbia to impose price controls on patented prescription drugs. In that case, the appellate court ruled that the price controls were preempted by federal patent law, which essentially engages in a trade-off with drug companies. To encourage research, development and innovation, the law grants drug companies a monopoly on their drugs for a period of time to allow the companies to charge whatever they want and recoup their R&amp;D costs.<\/p>\n<p class=\"wp-block-paragraph\">Domenico said that precedent directly applies to Amgen\u2019s lawsuit.<\/p>\n<p class=\"wp-block-paragraph\">\u201cColorado\u2019s attempt to rebalance Congress\u2019s patent system is preempted by federal law,\u201d he wrote.<\/p>\n<p class=\"wp-block-paragraph\">The state argued against the injunction by pointing to the pharmaceutical industry\u2019s famously complicated pricing system \u2014 which is so confusing that even Domenico expressed bafflement <a href=\"https:\/\/coloradosun.com\/2026\/06\/05\/amgen-drug-price-cap-lawsuit-pdab\/\" rel=\"nofollow noopener\" target=\"_blank\">during a hearing last month<\/a>. Essentially, the state\u2019s attorneys argued that Amgen couldn\u2019t show it would be harmed by the price cap, since it\u2019s possible the hit would be absorbed by others along the supply chain, such as distributors or pharmacies.<\/p>\n<p class=\"wp-block-paragraph\">But Domenico rejected that argument, at least in deciding the preliminary injunction.<\/p>\n<p class=\"wp-block-paragraph\">Addressing the argument by the state\u2019s attorneys, Domenico wrote: \u201cThey are right that the system is convoluted, confusing, and often counterintuitive. But it is not necessary to unravel the entire system to understand that, as a result of Colorado\u2019s cap, Amgen will receive less money from its wholesalers and will fare more poorly in negotiations with other purchasers in Colorado and elsewhere.\u201d<\/p>\n<p class=\"wp-block-paragraph\">The PDAB is a major component of Polis\u2019 efforts to lower healthcare costs, and the board moved methodically over more than four years to establish a process for reviewing drugs before ultimately setting the price cap on Enbrel. While other states <a href=\"https:\/\/www.multistate.us\/insider\/2025\/5\/15\/pdabs-and-upls-what-they-are-and-why-they-matter-for-drug-pricing-policy\" rel=\"nofollow noopener\" target=\"_blank\">have also created PDABs<\/a>, Colorado\u2019s was the first to impose a cap, which is known formally as an upper payment limit.<\/p>\n<p class=\"wp-block-paragraph\">The price cap on Enbrel was the only one Colorado\u2019s PDAB had issued so far, but it is in the process of studying caps on two other drugs, Stelara and Cosentyx, both of which treat autoimmune inflammatory conditions. Wednesday\u2019s ruling throws that work into question. While Stelara <a href=\"https:\/\/www.fiercepharma.com\/special-reports\/top-10-drugs-losing-us-exclusivity-2025\" rel=\"nofollow noopener\" target=\"_blank\">is now off-patent<\/a>, Cosentyx <a href=\"https:\/\/clival.com\/blog\/15-biologics-are-going-off-patent-2025-to-2029\" rel=\"nofollow noopener\" target=\"_blank\">still enjoys U.S. patent protections<\/a>.<\/p>\n<p class=\"wp-block-paragraph\">A spokesperson for the Colorado Division of Insurance, which oversees the PDAB, declined to comment citing the pending litigation.<\/p>\n<p class=\"wp-block-paragraph\">A consumer advocacy group that has backed the PDAB criticized the ruling.<\/p>\n<p class=\"wp-block-paragraph\">\u201cThis is a step backwards for Colorado and consumers,\u201d Adam Fox, the deputy director of the Colorado Consumer Health Initiative, said in a statement. \u201cDrugs don\u2019t work if people cannot afford them and this is yet another example of pharmaceutical companies throwing their weight around to keep their prices high and squeeze all the money they can from consumers.\u201d<\/p>\n<p class=\"wp-block-paragraph\">Amgen released a statement saying it was pleased with the decision.<\/p>\n<p class=\"wp-block-paragraph\">\u201cWe appreciate the court\u2019s careful consideration and remain confident in our position as the case moves forward,\u201d the statement read.<\/p>\n<p class=\"wp-block-paragraph\">The preliminary injunction issued Wednesday will remain in place at least until Amgen\u2019s underlying lawsuit is resolved, which could take months if not longer.<\/p>\n<p> Type of Story: News<\/p>\n<p>Based on facts, either observed and verified directly by the reporter, or reported and verified from knowledgeable sources.<\/p>\n","protected":false},"excerpt":{"rendered":"A federal judge has temporarily blocked Colorado\u2019s first-in-the-nation price cap on a specific prescription drug, saying that it&hellip;\n","protected":false},"author":2,"featured_media":1064209,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[4315],"tags":[176510,105,284563,4326,176512,176513,13683,16,15],"class_list":["post-1064208","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-colorado-division-of-insurance","tag-health","tag-jared-polis","tag-medication","tag-prescription-drug-affordability-board","tag-prescription-drug-costs","tag-prescription-drugs","tag-uk","tag-united-kingdom"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/116851633737270771","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/1064208","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=1064208"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/1064208\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/1064209"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=1064208"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=1064208"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=1064208"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}