New Drug Lowers Heart Attack Risk
Evan Douglas | March 21, 2017, 0:46
New Drug Lowers Heart Attack Risk
The results have also been published in the New England Journal of Medicine. They cost more than $80,000 for a course of treatment, but the drugs essentially cure a debilitating disease and they had no competition. The medicine lowers down the bad LDL cholesterol. Nissen and a few other doctors pondered if LDL levels so low could be unsafe.
As for safety, "patients who achieved the lowest levels of LDL, the lowest quartile, saw levels of 19 or less", Levy said, "and the safety profile in those patients was also pristine".
Sabatine said he would like to see Repatha tested in other high-risk patients, such as those with type 2 diabetes, which could substantially increase the market.
"Insurance companies are going to act like insurance companies, which in this case, probably means they'll want to see risk reductions of 20% minimum, maybe more like 25%", said Salim Syed, biotech analyst at Mizuho Securities.
To compensate, Amgen had the FOURIER study analyzed to look at the Repatha benefit starting at one year, focused on just heart attacks and strokes - the two adverse outcomes doctors care most about.
The offer isn't completely unprecedented.
Hard numbers are hard to come by in the US health care system.
Peter Bach, for instance, director of the Center for Health Policy and Outcomes at Memorial Sloan-Kettering, emphasized that the number of CV events prevented would be too small for payers to save much money. =============================== How do insurance companies decide what medicines to pay for and when to pay for them?
"It sounds like the patient gets harmed and the payer has its financial risk reduced", said New York-Presbyterian Hospital/Weill Cornell Medical Center cardiologist Cam Patterson.
One major barrier is its high cost - it has a U.S. list price of $14,000 a year per patient.
Still, Elliott Levy, Amgen's senior vice president of global development, said the study results were "about as good a result as you can get".
The patients in the study were already consuming statins and yet their risk was decreased further with the help of this the new therapy.
But the evolocumab benefit was driven by a reduction in heart attacks, revascularization, and stroke, with no difference in mortality, or hospitalization for unstable angina, or worsening heart failure. Rind also was not involved in the study. On average, participants in the Fourier study were 69 years old and more than two-thirds were taking moderate statins to lower cholesterol.
And the FDA approved evolocumab, made by Amgen in Thousand Oaks, California, only for certain patients, such as those with a hereditary condition that causes extremely high levels of LDL.
The standard treatment for cholesterol, other than diet and exercise, is a generic statin, which costs $250 a year.
"There are an terrible lot of people with really quite high cholesterol out there and we'll probably need more than one drug to get their levels down". However, it has been created to target a protein in the liver with the name PCSK9.
Repatha shots are given once or twice in a month while patients take statins regularly.
Given its price, doctors aren't likely to give Repatha to everyone with high cholesterol, Patterson said.
Amgen, though, clearly believes Repatha can meet expectations.
But they were approved only for those with a genetic condition that means they have dangerously high cholesterol, and people with heart disease who can not cope with the side effects of statins. Almost all were taking modest or large doses of statins. However, there are some deus which are prescribed to the patients with high levels of cholesterol but the cost of some them are really high. At one year, there was a 16% relative risk reduction for the combination of cardiovascular death, heart attack and stroke. It is an editorially independent program of the Henry J. Kaiser Family Foundation.