ICER says Merck & Co.’s sotatercept in PAH cost-effective up to $36,200

15 Nov 2023
firstwordpharma.com
Clinical ResultPhase 3AcquisitionLicense out/inNDA
Merck & Co.’s sotatercept would be cost effective for pulmonary arterial hypertension (PAH) if priced between $18,700 and $36,200 per year, according to an analysis by the Institute for Clinical and Economic Review (ICER). The review comes ahead of an FDA approval decision on the activin signalling inhibitor, which is due by March 26 next year.
David Rind, ICER’s chief medical officer, said “current evidence suggests that sotatercept has fewer side effects and improves short-term outcomes, but we have some uncertainties about long-term efficacy and safety.” The analysis raised concerns over sotatercept’s efficacy in sicker populations, and in those with connective tissue disease, as well as the durability of effect.
The submission to the FDA is based on data from the Phase III STELLAR trial, which showed that when added to background therapy, sotatercept demonstrated significant improvement over placebo on the main goal of exercise capacity as measured by six-minute walk distance (6MWD) at 24 weeks, as well as on eight of nine secondary outcome measures.
“In the absence of longer-term data, we necessarily have uncertainties about sotatercept’s effects on mortality and concerns about as-yet-undetected adverse effects,” ICER stated. The research institute concluded “we have moderate certainty of a small to substantial net health benefit, with a high certainty of at least a small net health benefit” for Merck’s therapy.
Sotatercept was the key drug in Merck's $11.5-billion acquisition of Acceleron Pharma in 2021 and is the subject of a licensing agreement with Bristol Myers Squibb.
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