For years, medical researchers have hoped that a burgeoning class of cholesterol drugs targeting a protein called PCSK9 could be the next generation of blockbuster treatments.
So if the data looked good, why did shares of Amgen fall?
Separately, Repatha cut heart attacks by 27 per cent and stroke by 21 per cent. “You have to make some real decisions about whether to stay on it”. Therefore, in order to find out if the claims held some truth, a study was conducted to note the effects of this new drug sponsored by Amgen, the maker of Repatha. An estimated 75% of prescriptions written for Repatha are rejected. Sales of Repatha totalled $141 million past year.
Insurance companies reluctant to pay for the drug may now have to reassess the situation after the results of the current study have been published. If the drug does not perform, net prices will go down.
Amgen implicitly acknowledged the cost-effectiveness issue by stating that the company “will offer additional contracting options in the U.S.to payers willing to remove access barriers”.
“These results, I think, will mean the guidelines are adjusted slightly, but unless the price comes down it won’t mean we give it to anyone by any means”, said Professor Naveed Sattar, a metabolic medicine expert of the University of Glasgow, according to The Daily Mail. In an exploratory analysis, the relative risk reduction for fatal and nonfatal heart attack or stroke was 19% in the first year (P = 0.003) and 33% beyond the first year (P 0.00001). The top line here is that for this population, it is going to be hard to justify the cost of these [PCSK9] medicines for the magnitude of the risk reduction, Weiss added. ( AMGN ) on Friday reported positive results from its Repatha cardiovascular outcomes study, dubbed FOURIER. “The open question was, ‘Does this way of lowering [cholesterol] reduce risk of coronary heart disease, ‘” says Sekar Kathiresan, a cardiologist at the Massachusetts General Hospital in Boston and the Broad Institute in Cambridge, Massachusetts, who was not involved in the study. Patients took either statins alone, or Repatha with their statins.
Furthermore, he noted, the drug was more effective at preventing the most serious events.
Repatha cut by 20 percent the combined risk of having either a heart attack, stroke or a heart-related death.
Given these findings, researchers at the American College of Cardiology believe that it could convince more people to start taking the cholesterol drug.
“Just like in statin trials the benefit appeared to grow over time”, said Dr. Marc Sabatine, the study’s lead researcher, who presented the data at the American College of Cardiology scientific meeting in Washington.
But while an accompanying editorial in the journal called it a “landmark study”, others expected a greater reduction in risk for its cost. The primary endpoint was the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.
Patients on the trial, who continued to take statins, were chosen to randomly receive either injections of evolocumab – 140 mg twice a month, or 420 mg once a month – or placebo injections.
Dr 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. After one year, that risk reduction rose to 25%.
After about two years, Repatha, used along with statins, reduced LDL from a median of 92 to 30.
They found that for every 200 patients treated with monthly Repatha injections for roughly two years, three fewer people would suffer a heart attack, stroke or heart-related death.
“However, the trial was stopped early after only 2.2 years of average follow-up”, Sir Nilesh said. Most importantly, he feels better, he says, and his doctors recently informed him that his cholesterol is now better than normal.