Amgen has its long-awaited approval to tout Repatha as a cardiovascular prevention tool. On the basis of a massive CV outcomes trial unveiled in March, the FDA blessed the cholesterol drug to fend off heart attacks, strokes and coronary revascularization surgeries in patients with heart disease.
In that trial, called Fourier, Repatha reduced heart attack risks by 27%, stroke risks by 21% and coronary revascularizations by 22%, Amgen says. With the FDA approval, Repatha becomes the first in its class of pricey new cholesterol drugs to boast the indication.
Now, Amgen hopes the distinction can help it grow sales and market share. "[I]t's now more important than ever that appropriate patients obtain access to Repatha in order to avoid preventable heart attacks and strokes," commercial chief Anthony Hooper said in a statement. "We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine."
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But while Amgen will work to make the most of its new nod, Bernstein analyst Ronny Gal isn't as enthusiastic. “We still do not expect much commercial impact," he wrote in a note on Monday.
Since launching Repatha in 2015, Amgen has struggled to win over payers reluctant to foot the bill for the drug, whose retail price is $14,000 per year, but far less with rebates and discounts. After the Fourier data were unveiled, some payers said the new approval would make some difference to their coverage decisions, but analysts were skeptical that the size of the CV benefit would be enough to make the cost worthwhile.
Controversial price watchdog ICER, or the Institute for Clinical and Economic Review, said the drug and its direct rival Praluent should be discounted by 60% or more to be cost effective, for instance.
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But Amgen has rolled out its own economic analyses, including an August report based on the mash-up of Fourier data and real-world numbers. That analysis showed Repatha is cost-effective at $9,669 per year or less—an amount consistent with what's generally paid after rebates and discounts, Amgen said at the time.
Another set of data could soon make an impact on Repatha, as well; it's expected yet this year or early next. Sanofi and Regeneron have conducted their own CV outcomes study, with the results potentially giving either company a competitive edge. But ICER has said it believes CV benefits are a classwide effect, so Repatha could benefit from that data too.