It’s Official: Evolocumab Gains Claim for CVD Event Reduction

On the basis of the FOURIER trial, the FDA says evolocumab is now indicated for reducing the risk of MI, stroke, and revascularization.

It’s Official: Evolocumab Gains Claim for CVD Event Reduction


(UPDATED) The US Food and Drug Administration (FDA) has permitted new labelling claims for evolocumab (Repatha, Amgen), making it the first PCSK9 inhibitor to be indicated for the prevention of cardiovascular events.

With the expanded indication, which was based on the results of the FOURIER trial, evolocumab is now approved for reducing the risk of MI, stroke, and coronary revascularization in adults with established cardiovascular disease.

In FOURIER, a 27,564-patient clinical outcomes study, adding evolocumab to statin therapy reduced the combined risk of hospitalization for unstable angina, coronary revascularization, MI, stroke, or cardiovascular death by 15% when compared with placebo. Treatment with evolocumab individually decreased the relative risk of MI by 27%, the risk of stroke by 21%, and the need for coronary revascularization by 22%.

Evolocumab has been available since 2015, when the drug was approved for lowering LDL cholesterol levels in patients with heterozygous or homozygous familial hypercholesterolemia and in those with clinical evidence of atherosclerotic cardiovascular disease.

The cost of evolocumab has been a major stumbling block for physician use, however. Both this drug and the competing PCSK inhibitor alirocumab (Praluent, Sanofi/Regeneron) are priced at more than $14,000 per year. Cost-effectiveness analyses have shown time and time again that evolocumab is not financially feasible for payers at the current list price. Earlier this summer, several experts lamented in a JAMA Cardiology editorial, for example, that the PCSK9 inhibitors “have achieved the dubious distinction of being the most expensive preventive therapies by far in the history of cardiovascular medicine.”

Ann Marie Navar, MD, PhD (Duke University School of Medicine, Durham, NC), who has previously shown that few patients prescribed PCSK9 inhibitors actually receive the medications, said it is difficult to determine if the new FDA indication will alter physician behavior. The outcomes data from FOURIER have been available since the American College of Cardiology (ACC) 2017 Scientific Sessions in March so it’s unlikely physicians would have been waiting for the FDA indication to start using evolocumab, she pointed out

“However, I do hope that the new indication, and moreover the data from FOURIER, do help drive better conversations between the manufacturers and payers to improve the process for patients to get access to the therapy,” said Navar in an email.

Seth Martin, MD (Johns Hopkins School of Medicine, Baltimore, MD), told TCTMD that he has been an “early adopter” when it comes to PCSK9 inhibitor use. “In my practice, I've already responded to the trial results and guidance from the ACC and [National Lipid Association], so the FDA indication doesn't change how I use evolocumab,” he noted in an email. “It's certainly a nice stamp of approval on the landmark FOURIER results and validation of my practice. I don't know if it will help with reimbursement issues, but certainly hope it does.”    

In a statement, Amgen Executive Vice president Anthony Hooper said the company “will continue to work with payers” so that patients who need evolocumab the most will have access to the drug.

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