ICER Draft Flags High Cost of New Hypertension Drug Class

A new class of blood pressure drugs lowers systolic blood pressure about as effectively as existing options, but the costs exceed the clinical benefit, according to a draft evidence report from the Institute for Clinical and Economic Review (ICER).¹ Cost-effectiveness ratios for aldosterone synthase inhibitors (ASIs) to treat hypertension reach as high as $2.08 million per quality-adjusted life year (QALY) gained compared with a cheap generic alternative.

The report evaluates baxdrostat (Baxfendy; AstraZeneca) and lorundrostat (Mineralys Therapeutics), the first drugs in a class called ASIs, which lower blood pressure by reducing the body's production of aldosterone. Baxdrostat was approved in May 2026 after a stumble 3 years earlier when the data from the phase 2 HALO trial (NCT05137002) missed the primary end point of change from baseline in mean seated systolic blood pressure after 8 weeks of treatment.^2,3 In the phase 3 BaxHTN trial (NCT06034743), on which the approval was based, the drug met all primary and secondary end points.⁴ Lorundrostat has an FDA action date of December 22, 2026.

ICER assessed the drugs for patients with treatment-resistant hypertension and for those whose blood pressure remains above goal despite taking multiple medications.¹ These populations together account for more than 12.5 million US adults, by ICER's estimate. The findings were released August 12, 2026, which marks the midpoint of ICER's 8-month evaluation process and are not final.

Comparing the New Drugs Clinically

In network meta-analyses, both baxdrostat and lorundrostat produced statistically significant reductions in systolic blood pressure (SBP) compared with placebo, in line with older add-on therapies such as spironolactone (Aldactone; Pfizer), eplerenone (Inspra; Pfizer), and amiloride (Midamor; Merck). But neither ASI showed a statistically significant advantage over existing generics when it came to lowering SBP, and the credible intervals were wide enough to leave open the possibility of meaningful differences in either direction, according to the report.

ICER rated the evidence comparing baxdrostat with lorundrostat as “insufficient” across all patient populations studied, meaning there is not enough data yet to judge whether one drug outperforms the other. Compared with spironolactone, eplerenone, or amiloride, both ASIs were considered “promising but inconclusive,” which reflects their potential for better tolerability compared with older agents. For instance, mineralocorticoid receptor antagonists, such as spironolactone and eplerenone, are often limited by adverse effects, including hyperkalemia and gynecomastia.

Currently, there is a lack of long-term outcomes data for baxdrostat and lorundrostat, and neither drug has been shown to reduce cardiovascular events, kidney disease, or mortality, all of which are outcomes that the older comparators already have established evidence for, the report noted.

Why Do the Drugs Fall Short on Cost-Effectiveness?

The added health benefit for the ASIs is small enough that these drugs would cost payers far more per patient than achieving a similar gain with the existing, less expensive generics. Using a wholesale acquisition cost of $10,950 per year for baxdrostat and an identical placeholder price for lorundrostat since it is not yet approved, ICER calculated incremental cost-effectiveness ratios ranging from $833,000 to $2.08 million per QALY gained relative to the older generics. That far exceeds the $50,000 to $150,000 per QALY range commonly used as a value benchmark. By contrast, spironolactone, eplerenone, and amiloride cost as little as $43 to just over $1000 annually.

At baxdrostat's base-case price, only about 2% of eligible patients could be treated before crossing the $821 million potential budget-impact threshold that ICER uses to flag when a new therapy could strain health system budgets and trigger the need for pricing or access interventions. Baxdrostat would need steep discounts to reach a more favorable value-based price: at a $50,000-per-equal-value life-year threshold, ICER estimated baxdrostat's price would need to fall to roughly $1100 to $1200 a year, compared with its current $10,950 list price.

A Disproportionate Impact on Black Patients

Despite the steep price tag, ICER's equity analysis found Black Americans could benefit disproportionately from effective ASI treatment. Nearly half of US adults live with hypertension, but prevalence is highest among Black Americans, at 57.8%, compared with the overall population. Using a Health Improvement Distribution Index, ICER calculated that Black Americans could see roughly 20% greater impact from effective blood pressure treatment than the general population as a result of the higher disease burden among the population and longstanding barriers to blood pressure control.

The finding echoes a growing body of research on hypertension disparities, including data showing that fragmented ambulatory care is linked to a substantially higher likelihood of uncontrolled, treatment-resistant hypertension among older Black adults and evidence that neighborhood-level deprivation compounds racial gaps in hypertension prevalence and control.^5,6

ICER's Review Timeline Moving Forward

ICER's draft report is now open for public comment through September 9, with a revised evidence report expected around October 1.¹

The independent Midwest Comparative Effectiveness Public Advisory Council will vote on the report's key questions at a virtual public meeting on October 29, a step that typically shapes the policy recommendations and any updated price benchmark that appear in ICER's final report.

References

1. Aldosterone synthase inhibitors for hypertension: effectiveness and value. Draft evidence report. Institute for Clinical and Economic Review. August 12, 2026. Accessed August 14, 2026. https://icer.org/wp-content/uploads/2026/08/ICER_Hypertension_Draft-Report_For-Publication_081226.pdf
2. Baxfendy approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension. News release. AstraZeneca. May 18, 2026. Accessed August 14, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/Baxdrostat-MNR-2026.html
3. Caffrey M. HALO misses end point, but optimism remains for baxdrostat in resistant hypertension. AJMC^®. March 5, 2023. Accessed August 14, 2026. https://www.ajmc.com/view/halo-misses-end-point-but-optimism-remains-for-baxdrostat-in-resistant-hypertension
4. Baxdrostat demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with hard-to-control hypertension in the BaxHTN phase III trial. News release. AstraZeneca. August 30, 2025. Accessed August 14, 2026. https://www.astrazeneca-us.com/media/press-releases/2025/Baxdrostat-demonstrated-statistically-significant-and-clinically-meaningful-reduction-in-systolic-blood-pressure-in-patients-with-hard-to-control-hypertension-in-the-BaxHTN-Phase-III-trial.html
5. Colvin CL, Safford MM, Muntner P, Colantonio LD, Kern LM. Health care fragmentation and blood pressure control among adults taking antihypertensive medication. Am J Manag Care. 2022;28(3):108-115. doi:10.37765/ajmc.2022.88837
6. Bonavitacola J. Association found between neighborhood deprivation, hypertension. AJMC. August 23, 2024. Accessed August 14, 2026. https://www.ajmc.com/view/association-found-between-neighborhood-deprivation-hypertension