The Institute for Clinical and Economic Review (ICER) released a draft evidence report on two new drugs for treatment-resistant hypertension, baxdrostat and lorundrostat, which found they did not lower blood pressure much more than decades-old generic drugs and are even more expensive.
Both baxdrostat and lorundrostat belong to a new drug class called aldosterone synthase inhibitors (ASIs), which lower blood pressure by reducing the body’s production of aldosterone.
Hypertension affects nearly half of U.S. adults, contributes to more than 600,000 U.S. deaths a year, and costs an estimated $219 billion annually in medical spending, according to the report.
About 7 million Americans have apparent treatment-resistant hypertension, meaning their blood pressure stays above goal despite taking three or more antihypertensive drugs at the maximum tolerated doses.
ICER noted they conduct these reviews to give payers, clinicians, and patients an independent assessment of a drug’s comparative effectiveness and fair price.
The overall draft report is planned to be revised based on public comment ahead of a vote by the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC).
To conduct this study, ICER researchers built a network meta-analysis pooling randomized, placebo-controlled trials of baxdrostat and lorundrostat, comparing the drugs with spironolactone, eplerenone, and amiloride.
ICER then built an economic model to estimate cost per quality-adjusted life year (QALY) gained for each drug against its comparators.
In patients with resistant hypertension, baxdrostat and lorundrostat reduced systolic blood pressure by about 11 mmHg and 9 mmHg versus the placebo.
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Reductions found were not statistically different from the roughly 7-to-10-mmHg reductions produced by spironolactone, eplerenone, and amiloride, though this came with much uncertainty.
ICER rated the evidence “promising but inconclusive” for both ASIs against those three generics.
On cost, ICER’s economic model used $900 for a 30-tablet supply as baxdrostat’s price, citing wholesale acquisition cost (WAC) data from Red Book.
Against spironolactone and amiloride, baxdrostat’s cost came to roughly $833,000 and $851,000 per QALY; against eplerenone, it topped $2 million.
The drugs did seem easier to tolerate over spironolactone when it came to hyperkalemia, which occurred in 10.2% of patients on the higher, 2-mg dose of baxdrostat and 2.5% of patients on lorundrostat, compared with 17.5% on spironolactone.
ICER also flagged bigger gaps in the evidence: no published trial of either drug has measured its effect on cardiovascular events, the longest baxdrostat trial ran only 26 weeks, and the trials excluded patients with advanced chronic kidney disease (CKD), a group at raised risk of hyperkalemia.
“Although there appears to be no statistically significant difference in blood-pressure lowering between agents, there were small differences (2-4 mmHg) between the ASI agents compared with eplerenone or amiloride that, if real, could over years result in clinically significant differences in outcomes,” ICER’s researchers wrote in the report.
ICER is accepting public comments on the draft through Sept. 9, and the Midwest CEPAC will vote on the report’s key questions during a virtual meeting Oct. 29.
