Cardiologist Talks About Value of Monoclonal Antibody Evolocumab

A leading cardiologist and supporter of a monoclonal antibody that works to slash “bad” cholesterol spoke Wednesday at the Academy of Managed Care Pharmacy’s Managed Care & Specialty Pharmacy Annual Meeting held April 23-26, in Boston, Massachusetts, to discuss evolocumab's value and how it is being underutilized despite a December labeling change by the FDA.

Seth J. Baum, MD, FAAC, FACPM, FAHA, FNLA, FASPC, president of the American Society for Preventive Cardiology, talked about evolocumab (Repatha) at the Science and Innovation Product Theater, sponsored by Amgen, maker of Repatha. In “Understanding the Value of Repatha,” Baum made sure the audience understood the significance of the expanded indication.

Evolocumab, first approved in 2015, is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor and blocks the PCSK9 enzyme, preventing its ability to stymie the liver from filtering low-density lipoprotein (LDL) cholesterol out of the blood. PCSK9 inhibitors can reduce LDL cholesterol by up to 60%.

The approval was first limited to high-risk patients and those with genetic conditions that cause high cholesterol. With the expanded indication, “it is no longer mandatory to try statins,” said Baum. Statins are still the first line of treatment, but payers should stop emphasizing how many trials of statins a patient must go through before being permitted to try evolocumab, he said. Instead, patients should be treated according to their risk.

Baum said evolocumab is indicated for prevention of cardiovascular events in adults with established cardiovascular disease to reduce the risk of heart attack, stroke and coronary revascularization. The secondary indication is for primary hyperlipidemia where the drug, as an adjunct to diet alone or in combination with other lipid-lowering agents like statins, can treat adults with primary hyperlipidemia to reduce LDL cholesterol.

Current guidelines advise lowering LDL cholesterol to below a target of ≤70 mg/dL. But despite treatments with maximum statin therapy, 80% of adults with established cardiovascular disease are not achieving that goal, he said.

In addition, about 7.6% of patients with cardiovascular disease and LDL choleseterol levels greater than 70 mg/dL treated with statins experience a recurring event annually. Of those, 3.2% have a revascularization, 2.3% have a heart attack and 2.1% have a stroke, Baum said.

Baum also reviewed results from the FOURIER trial, which were released late last year. The greatest effect was seen when the drug was started on patients who had had a qualifying cardiovascular event within the prior 2 years. In other words, treat early and aggressively, Baum said.

Baum also referred to the valuation studies that have been done on evolocumab or other drugs by places like the Institute of Clinical and Economic Research or payers, who think the treatments should be priced less. In his view, the reports will depend on what criteria are being used at the outset (inputs) and in addition, real-word events will always have more data than clinical trials. Valuation reports that reflect only clinical trials may not reflect all factors, he said.

"Real-world data gives a much better sense of the value of the medication," Baum said.