Эксперты ICER сочли новый препарат AstraZeneca от гипертонии слишком дорогим для своей эффективности

AstraZeneca’s 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. In a draft report (PDF), ICER concludes Baxfendy is too expensive to 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. The WAC, or 'list price,' of a drug does not represent what patients ultimately pay at the pharmacy counter. ICER also used the same price as a placeholder to assess Mineralys Therapeutics’ 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’ aldosterone synthase inhibitor (ASI) does not measure up. “At 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,” ICER wrote. While acknowledging the limitations of cross-trial comparisons, ICER added that their analysis could not differentiate whether “one agent has superior blood pressure lowering over the other.” ICER wrote that the health benefits of baxdrostat or lorundrostat are “promising but inconclusive” 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’t be adequately controlled. In its report, ICER also said that questions remain about the “long-term effects of ASIs,” and their efficacy and safety in subgroups, specifically those with chronic kidney disease. In response, an AZ spokesperson pointed out that millions of people in the U.S. do not have their blood pressure under control despite being on multiple medications. “Aldosterone synthase inhibitors, including Baxfendy, represent the first new innovation in hypertension management in more than two decades. Baxfendy offers patients clinically meaningful blood pressure reductions supported by a robust body of scientific evidence, and we are continuing to support access to this new therapy for patients across the U.S.," the spokesperson added. 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’ blood pressure on average by nearly 10 mmHg when adjusted for placebo. The reduction in mean seated systolic blood pressure in the trial’s placebo cohort clocked in at 5.8 mmHg. AZ leadership has pegged 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 by 2030. AZ acquired Baxfendy in a $1.3 billion buyout of its developer CinCor Pharma in 2023.