Amgen reported long-awaited positive outcomes data for its PCSK9 inhibitor, Repatha, which it believes will help make the case for the drug to payers.
The data, released Friday at the American College of Cardiology’s annual conference, showed the drug reduced the risk of heart attack and stroke by 27% and 21%, respectively, but it did not reduce the risk of death. The drugmaker also said it would offer payers an option to refund the cost of Repatha for patients who have a heart attack or stroke while taking the cholesterol-lowering injection in exchange for removing what it calls “access barriers.”
“Now that Repatha has proven a meaningful reduction in cardiovascular events, we expect payers to remove onerous barriers and help appropriate patients get access to Repatha,” Joshua Ofman, Amgen’s SVP of global value, access, and policy, said in a statement.
However, at a list price of $14,500 per year of treatment, there are still doubts about Repatha’s chances at widespread adoption. There are concerns around the commercial potential of the drug, which has failed so far to meet analysts expectations, Credit Suisse analyst Vamil Divan wrote in an investor note.
Dr. Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes, took to Twitter to say that although the refund “sounds great,” it only applies to heart attacks and strokes, which were reported in only 4.9% of patients participating in the outcomes trial. “So tiny savings,” he tweeted.
The FDA approved Repatha in 2015 for patients who need their cholesterol lowered beyond what statins can provide. The drug is also approved to treat patients with two rare diseases: heterozygous familial hypercholesterolemia and homozygous familial hypercholesterolemia, as well as patients with heart disease who require additional lowering of LDL cholesterol.
Both Repatha and its primary competitor, Sanofi and Regeneron’s Praluent, were approved in 2015 with much fanfare from analysts, which gave the drugs blockbuster estimates as high as $3 billion per year. The drugs have yet to hit anywhere near those lofty projections: Praluent generated $111 million in sales last year, while Repatha brought in $141 million.