Amgen’s (NASDAQ:AMGN) new cholesterol treatment, called Repatha, can cut patients’ stubbornly high cholesterol, but comes at a high price. Repatha is approved to lower LDL, or “bad,” cholesterol by blocking a bodily protein called PCSK9. A new study shows that the cholesterol-cutting drug succeeded in lowering patients’ risk of cardiovascular issues in a clinical trial.
In a two-year trial on more than 27,000 patients with heart disease, Amgen’s drug cut the risks of a bad outcome by 15 percent. A bad outcome was defined as heart attack, stroke, hospitalization for chest pain, placement of a stent, or death. The participants of the study were men and women who had exhausted all other options for lowering their cholesterol.
It was widely expected that Repatha would cut that bundle of cardiovascular problems by 20 percent. In a survey conducted by analysts at Leerink, about half of the respondents said they expected a median improvement of 20 percent on the trial’s primary endpoint. Looking at death rates alone, there was no significant difference between the two groups. Amgen’s stock fell roughly 7 percent after the data became public.
The results of the study were published in The New England Journal of Medicine on Friday and were presented at the American College of Cardiology’s annual meeting. The study cost about $1 billion and was paid for by Amgen.
Amgen’s discussions with payers and pharmacy benefit managers over the price of the drug have been contentious. Many of them have balked at the drug’s roughly $14,000-a-year list price. Repatha’s list price doesn’t account for the customary discounts and rebates, which average around 30 percent across the industry.
Amgen has long complained that insurers are rejecting prescriptions for Repatha. Insurers and benefit managers rejected more than three-fourths of prescriptions that physicians wrote for Repatha before the new data came out. To be approved by insurers, doctors have to submit documentation proving that patients have an inherited disorder that leads to dangerously high LDL levels, or that their high cholesterol has continued despite two rounds of statin therapy.
Dr. Sean Harper, Amgen’s head of R&D said Repatha’s ability to reduce the risk of expensive hospitalization more than justifies its price. Amgen has agreed to refund the cost of Repatha if patients suffer a heart attack or stroke while taking the drug. Dr. Joshua Ofman, Amgen’s senior vice president of value, access, and policy, said, “We want to put our money where our mouth is. We stand by our product, and we’re willing to take risks around outcomes.”