The Institute for Clinical and Economic Review (ICER) on Monday, July 21, posted an evidence report on Intercept Pharmaceuticals’ obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH).
ICER CMO David Rind in a statement said the review concluded there was much uncertainty about OCA.
“Although we do not know the reasons for the FDA decision, ICER’s review of OCA concluded that the potential cardiovascular risks of therapy led to uncertainties about whether treatment would be beneficial or harmful in many patients,” he said.
Among the key findings presented by ICER, researchers found that the treatment could reduce progression to cirrhosis, but that “the magnitude of this benefit is uncertain.”
To read the evidence report, click here.