13 June 2017 - Newly released clinical trial data show expected reductions in stroke and heart attack, but mortality benefit assumed in original cost-effectiveness analysis not found.
Following release of new clinical evidence in March 2017, the Institute for Clinical and Economic Review (ICER) has developed a New Evidence Update to its 2015 review of the comparative clinical effectiveness and value of PCSK9 inhibitors for management of high cholesterol. The comparative clinical effectiveness portion of the update is now available.
The update covers new information issued since the 2015 ICER report on PCSK9 inhibitors, including an analysis of recently-released evidence from the FOURIER trial of evolocumab. These results showed that evolocumab combined with statins is effective in reducing the incidence of cardiovascular events such as heart attack and stroke, but did not show a statistically significant reduction in cardiovascular mortality. The cost-effectiveness analysis in ICER’s 2015 review had assumed a mortality benefit that was not found in the FOURIER study.