AstraZeneca\u2019s newly approved, first-in-class hypertension drug Baxfendy does not clear the bar for effectiveness relative to its price, according to the Institute for Clinical and Economic Review (ICER), a U.S. non-profit drug price watchdog.<\/p>\n
In a draft\u00a0report<\/a> (PDF), ICER concludes Baxfendy is too expensive\u00a0to meet traditional cost-effectiveness measures. For its assessment, ICER used a wholesale acquisition cost (WAC) of $900 for a supply of 30 Baxfendy tablets, adding up to an annual cost before discounts and rebates of $10,800.<\/p>\n The WAC, or ‘list price,’ of a drug does not represent what patients ultimately pay at the pharmacy counter.\u00a0<\/p>\n ICER also used the same price as a placeholder to assess Mineralys Therapeutics\u2019 investigational treatment lorundrostat, which carries the same mechanism of action as Baxfendy and is up for an FDA decision in December. ICER came to the same conclusion that Mineralys\u2019 aldosterone synthase inhibitor (ASI) does not measure up.<\/p>\n \u201cAt their current WAC-based price and placeholder price, the incremental cost-effectiveness ratios for baxdrostat and lorundrostat were well above commonly used cost-effectiveness thresholds,\u201d ICER wrote.<\/p>\n While acknowledging the limitations of cross-trial comparisons, ICER added that their analysis could not differentiate whether \u201cone agent has superior blood pressure lowering over the other.\u201d<\/p>\n ICER wrote that the health benefits of baxdrostat or lorundrostat are \u201cpromising but inconclusive\u201d compared to those for generic blood pressure medicines such as spironolactone, eplerenone and amiloride. Baxfendy was approved by the FDA in May of this year to be used with other antihypertensive therapies in patients with high blood pressure that can\u2019t be adequately controlled.<\/p>\n In its report, ICER also said that questions remain about the \u201clong-term effects of ASIs,\u201d and their efficacy and safety in subgroups, specifically those with chronic kidney disease.<\/p>\n Neither company immediately responded to a request for comment.<\/p>\n The approval of Baxfendy was backed by results from a phase 3 trial which showed that it helped curb blood pressure at statistically significant and clinically meaningful levels in patients who were already taking two or more hypertension meds. At week 12 of the study, a 2 mg dose of Baxfendy helped reduce patients\u2019 blood pressure on average by nearly 10 mmHg when adjusted for placebo. The reduction in mean seated systolic blood pressure in the trial\u2019s placebo cohort clocked in at 5.8 mmHg.\u00a0<\/p>\n AZ leadership has pegged<\/a> the peak sales potential of Baxfendy at $5 billion, with the medication expected to play a role in the company achieving its goal to reach annual sales of $80 billion<\/a> by 2030. AZ acquired Baxfendy in a $1.3 billion buyout of its developer CinCor Pharma in 2023.<\/p>\n","protected":false},"excerpt":{"rendered":"AstraZeneca\u2019s newly approved, first-in-class hypertension drug Baxfendy does not clear the bar for effectiveness relative to its price,…\n","protected":false},"author":2,"featured_media":102876,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[20662],"tags":[11153,29324,43159,20701,43158,43160,10253],"class_list":["post-102875","post","type-post","status-publish","format-standard","has-post-thumbnail","category-astrazeneca","tag-astrazeneca","tag-fierce-pharma-homepage","tag-high-blood-pressure","tag-hypertension","tag-icer","tag-mineralys-therapeutics","tag-pharma"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@UnitedKingdom\/117089068816288913","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/102875","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/comments?post=102875"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/102875\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media\/102876"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media?parent=102875"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/categories?post=102875"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/tags?post=102875"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}