AstraZeneca’s (AZN) first-in-class hypertension drug Baxfendy does not meet cost-effectiveness standards relative to its price, according to U.S. drug price watchdog ICER.
The Institute for Clinical and Economic Review published a draft report concluding that Baxfendy is too expensive to satisfy traditional cost-effectiveness measures used in the industry.
ICER based its assessment on a wholesale acquisition cost of $900 for a 30-tablet supply, translating to an annual list price of $10,800 before discounts and rebates are applied.
The list price does not reflect what patients ultimately pay at the pharmacy counter, as rebates and insurance negotiations typically reduce the final cost significantly.
ICER applied the same placeholder price to assess lorundrostat, an investigational treatment from Mineralys Therapeutics that shares Baxfendy’s mechanism of action and faces an FDA decision in December.
The watchdog reached the same conclusion for Mineralys, finding that its aldosterone synthase inhibitor also fails to clear the cost-effectiveness bar at current pricing levels.
“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.
ICER also noted that its analysis could not determine whether “one agent has superior blood pressure lowering over the other,” citing the limitations of cross-trial comparisons.
The report described the health benefits of baxdrostat and lorundrostat as “promising but inconclusive” when compared to generic blood pressure medicines such as spironolactone, eplerenone, and amiloride.
ICER further raised concerns about the “long-term effects of ASIs” and their efficacy and safety in specific patient subgroups, including those with chronic kidney disease.
Baxfendy received FDA approval in May 2026 for use alongside other antihypertensive therapies in patients whose blood pressure cannot be adequately controlled by existing treatments.
The drug’s approval was supported by phase 3 trial results showing that a 2 mg dose reduced patients’ blood pressure by nearly 10 mmHg at week 12 when adjusted for placebo.
The placebo cohort in that same trial recorded a reduction in mean seated systolic blood pressure of 5.8 mmHg over the same period.
AstraZeneca leadership has projected peak sales potential for Baxfendy at $5 billion, with the drug expected to contribute to the company’s target of reaching $80 billion in annual sales by 2030.
AstraZeneca acquired Baxfendy through a $1.3 billion buyout of its developer CinCor Pharma in 2023, underscoring the strategic importance of the drug to its long-term growth ambitions.
Neither AstraZeneca nor Mineralys Therapeutics immediately responded to requests for comment on ICER’s draft findings.