Preliminary New Evidence Update

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PCSK9 Inhibitors: Preliminary New Evidence Update

This Preliminary New Evidence Update for PCSK9 inhibitor alirocumab (Praluent®, Regeneron/Sanofi) incorporates results from the ODYSSEY outcomes trial presented at the American College of Cardiology’s 2018 Scientific Session. Under ICER’s established protocols for accepting in-confidence data, an agreement with Regeneron and Sanofi allowed ICER to evaluate the new evidence and, working with a team of academic faculty from the University of California, San Francisco, to update its cost-effectiveness analyses and associated value-based price benchmarks for this drug.

Given these new outcomes data confirming a mortality benefit for alirocumab, ICER is issuing this preliminary update to help inform new pricing and coverage negotiations between manufacturers and payers. We plan to issue a final New Evidence Update for alirocumab by May 3, 2018, following the methodology and procedures defined on our website.


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