The question now is whether physicians and health-care payers will consider that benefit great enough to warrant the annual price tag of roughly US$14,000.
In an effort to ease insurers’ concerns, Amgen also announced in the study’s press release that it plans to offer “additional contracting options” to USA payers that are willing to remove restrictions on accessing Repatha. Time will tell if this cynicism is justified, or if the new drugs are worth the price.
Amgen is “very confident”, Dr.
Some independent observers disagree with Amgen, and insurance companies have yet to weigh in.
It will be tough to justify a medication that costs $1,500 per month when the results may be nearly as good for generics that can be found for 1 percent of that.
“A 15% relative reduction in risk for the primary endpoint is much lower than predicted based on prior trials”. This also might suggest that the longer follow-up with the Odyssey Outcomes trial may produce a more robust result. Syed spoke to me before the Repatha FOURIER results were reported.
Unfortunately, evolocumab did not reduce a person’s overall risk of death, or their risk of dying from heart disease, noted Dr. Gregg Stone, director of cardiovascular research and education at NewYork-Presbyterian/Columbia University Medical Center.
The Fourier trial tested Repatha in patients at high risk of a cardiovascular event, a group where Amgen sees a high unmet need, with no real advances in treatment in more than a decade. Repatha and Praluent from Regeneron Pharmaceuticals Inc and Sanofi are injected either every two or four weeks. Repatha is part of class of cholesterol drugs targeting the PCSK9 protein to control cholesterol and heart-disease risk.
Last May NHS watchdog NICE approved Repatha and a similar drug called Praluent on the basis of early trials. It showed widely varying effects on LDL cholesterol levels and had no benefit for people with LDL levels below 100, although patients with higher LDL levels did see significant benefits.
Researchers report that patients treated with evolocumab had a 15 percent reduction in the risk of major cardiovascular events, defined as the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (occurring in 9.8 percent of patients treated with evolocumab vs. 11.3 percent of patients treated with placebo).
Cardiologists not involved with the study say this is a big deal but caution it may be a big disappointment to insurers reluctant to pay for the pricey drug which costs $14,000 a year. The FOURIER trial (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk) was created to determine whether evolocumab, when added to statin therapy, would reduce adverse cardiovascular events.
WASHINGTON, DC-The first late-breaking clinical trials of the American College of Cardiology 2017 Scientific Sessions started today with a mix of LDL-lowering drugs and interventional therapy in aortic valve disease. But researchers didn’t have evidence then that the drug could also protect against heart attacks or strokes.
“You have a treatment regimen that gives you on average, with an initial starting dosing regimen, a 50 percent (LDL) reduction through to nine months”, said Ray. “There’s benefit in preventing a heart attack”. The primary endpoint of the study was measured as a composite of a number of related conditions such as heart attack or stroke, or death from CVD.
“It is much more effective than statins“, said Prof Peter Sever, from Imperial College London.
This alternative analysis – not included in the NEJM publication but presented at the cardiology conference Friday – showed Repatha reduced the risk of heart attack and stroke by 33% compared to placebo, Harper said.
Get ready to negotiate, payers: Amgen has its PCSK9 outcomes data.
The inclisiran dosage that produced the best results would require a person to get an initial shot followed by a booster three months later, Ray said.