Fish-Oil Heart Medicine Is Rarest of Drug Breakthroughs

(Bloomberg Opinion) -- When medical breakthroughs are announced, they often affect a surprisingly small number of people, or at least initially. A growing share of new drugs these days are targeting rare diseases or niche patient groups, and their impact is further restricted by price. 

Monday’s results from Amarin Corp.’s test of purified fish oil Vascepa in people at risk for heart diseases are an exception — and one more likely than any recent drug outcome to affect the average person reading this column.

Vascepa was shown to reduce the risk of cardiovascular events like heart attack or stroke by 25 percent in high-risk patients, much more than analysts hoped for, and without side effects. Add to that its relative cheapness, and it’s a result that could affect millions, change how heart disease is approached and justify the more than tripling of Amarin’s share price Monday morning. In fact, it may be the rarest success of all: a breakthrough that cost-conscious, health-care gatekeepers don’t hamper, but embrace.  

Fish-Oil Heart Medicine Is Rarest of Drug Breakthroughs

It’s been easy to doubt Amarin, which has been working on this trial for the better part of a decade. The scientific rationale is there: Omega-3 fatty acids like the one Amarin is testing can reduce high triglycerides, a risk factor for cardiovascular disease. But many previous fish-oil trials have failed. Vascepa’s purity enables a higher dose without raising cholesterol, as other fish oils can. Amarin bet that focusing on high-risk patients with persistently high triglycerides would reveal the benefit of that higher dose, and was proven correct.  

Insurers already approve coverage of the drug for use by a small group of patients with very high triglicerides, but there is a strong case to be made to expand coverage more broadly. Cardiovascular disease is the leading cause of death in the U.S., and heart attacks and strokes are incredibly expensive for the health-care system. Preventing them not only saves lives, it saves money.  

Other drugmakers have tried and failed to make a similar argument with other treatments, most notably so-called PCSK9 inhibitors drugs from Amgen Inc. and Sanofi and Regeneron Pharmaceuticals Inc. These medicines are able to dramatically lower bad cholesterol beyond what older statins can manage, and can significant reduce cardiovascular events in a high-risk population. But their list price of more than $14,000 at launch has caused insurers to substantially restrict availability.

Amarin said on a Monday morning conference call that it will revisit its pricing, but right now Vascepa’s list price is about $2,400 a year,  much lower than those other drugs. That kind of price, combined with the number of people that could benefit and the size and rigor of the trial, will make aggressive restriction difficult. 

Fish-Oil Heart Medicine Is Rarest of Drug Breakthroughs

Some skepticism about previous failures and Amarin’s claims that its drug’s purity is difficult to replicate will remain, and the company didn’t disclose data on important secondary endpoints Monday. But in an industry where progress is too frequently incremental and inaccessible, this is a rare result where the real-world impact may exceed the hype. 

This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.

Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.

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