On Friday 17th March the much expected results of study on Repatha, Amgen’s drug were pubblished.
Surely the news that Amgen Inc.’s cholesterol-lowering drug Repatha it significantly reduced the chance that a high-risk patient would have a heart attack or a stroke and not just reduce levels of LDL cholesterol was good news.
However the cost of it will be an issue as statins are available as cheap generics while the new drug have a list price of $14,523 a year. So far
insurance companies have been reluctant to pay for the drug without having evidence that it protected high-risk patients from heart attacks and strokes.
The investors however were apparently disappointed by the results and Amgen’s shares fell by 6% (also stocks of Regeneron, which sells a competing drug, Praluent were down), assuming that insurers would continue to restrict access to the drug, in part because it did not show a benefit in overall death rates from cardiovascular causes.
Stronger trial data might have helped Amgen force PBMs ( harmacy benefit managers) to accept the reality of Repatha’s high price.
Dr. Harlan Krumholz, a Yale cardiologist called the study “a solid outcomes trial” and said “we should celebrate” as it showed the drug is capable of reducing risk. However according to him the problem was the expectetion
agreed that given the expense of the drug, the results raise questions about what it is worth and who should get it.
The problem, he said, was that expectations were running so high. “There was a lot of hubris about how pushing LDL down to 30 would eliminate heart disease,” he said, but it did not.
For cardiologists, the study was a crucial test of a long-held hypothesis: the lower the level of cholesterol in the blood, the better.
On its side, the company says that its drug is worth the price and that by preventing heart attacks and strokes, it will also prevent the costs associated with treating patients with worsening conditions.
However the drug would need to be taken for life, and the bill for its widespread use could potentially be huge