New US Cholesterol Guidelines Hit PCSK9s Hard On Pricing, Value
Already outdated? The latest ACC/AHA guidelines say at mid-2018 list prices, PCSK9 injectables are of low value, but the costs have plummeted since then.
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Amarin won't seek approval in the EU until later this year, but doctors there are encouraged to consider Vascepa for patients with high triglycerides despite statin therapy. Also, PCSK9 inhibitor guidelines were solidified for very high risk patients.
ODYSSEY Outcomes data added to US label for Praluent; update includes claim for reduced cardiovascular incident risk and trial data indicating an all-cause mortality benefit.
Data may pave way for inclusion in heart disease treatment guidelines, ACC spokesperson says.