Both Johnson & Johnson and Amarin scored preliminary wins in July when two of their cardiovascular drugs were deemed cost-effective by an influential U.S. price watchdog. A follow-up report released Thursday backs up those findings—but there’s a catch.
The Institute for Clinical and Economic Review (ICER) unveiled its final evidence report on J&J’s Xarelto and Amarin’s Vascepa, finding both drugs hit the group’s cost-effectiveness standards when used as add-on treatments for CV disease.
It’s a win for both drugs, but particularly for Vascepa, which is awaiting an FDA advisory committee hearing on a major label expansion.
But the positive guidance came with a caveat: ICER admitted the drugs were cost-effective but said the U.S. healthcare system couldn't afford to cover the many thousands of patients who'd be eligible.
In an “access and affordability alert," ICER said the drugs “may be difficult for the health system to absorb over the short term without displacing other needed services or contributing to rapid growth in health care insurance costs that threaten sustainable access to high-value care for all patients.”
Citing a survey from a physician meeting, ICER said doctors considered using Xarelto in 30% or more of eligible U.S. patients. But by the group's calculations, based on annual costs, only 6% of those patients could be treated before busting payers' budgets. Xarelto is FDA-approved as an add-on to aspirin to reduce the risk of serious heart problems, heart attack and stroke in people with coronary artery disease.
Vascepa would be even more popular, ICER said. “[C]linical experts at the meeting stated they believe the majority of eligible patients would want to be on” Vascepa. But only 4% of patients could be treated without crossing a budgetary red line, the watchdog said.
Amarin said ICER's guidance "understates the true value of Vascepa" and argued that the group's alert put undue scrutiny on a drug it had already found cost-effective.
"We do not believe that a limit should be set on the use of a cost-effective therapy," the company said in an email. "If the group is looking for societal cost savings, there are many therapies which they have deemed not to be cost-effective which seem more deserving of attention."
The drugmaker said it intended to present a separate cost-effectiveness analysis for Vascepa at the American Heart Association Scientific Sessions in November in Philadelphia.
A spokesperson for J&J could not be reached for comment.
For Amarin, the alert takes a bit of shine off a drug looking at a bright future with a major label expansion in the offing.
The FDA plans an advisory committee meeting Nov. 14 to review Amarin’s application to add a cardiovascular risk-reduction indication to Vascepa’s label. The label decision was initially set for Sept. 28, but an approval will likely wait until December.
Amarin said the committee would sift the results of Vascepa’s Reduce-It outcomes trial, which showed the drug cut the risk of CV events by 26% in patients with abnormally high triglycerides compared with placebo. Those trial results, unveiled in October 2018, were touted as a “landmark” achievement for Vascepa and a potential sign of a blockbuster drug in the making.
Vascepa sales have been on the up and up since those results were released in October, with Amarin pocketing $100.4 million in the second quarter—a 91% increase over the same period in the previous year.