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 significantly 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. 

Eoin Treacy's view

When Mrs. Treacy developed pancreatitis in her first pregnancy our doctor referred us to a cardiologist for her second pregnancy. At the time her triglycerides were 10 times the normal amount and labs had to recalibrate their machinery to test the levels of fats in her blood, which was separating like oil and water in the vials. He gave her a strict diet of no saturated fats and high does of cod liver oil daily for the last five months of the pregnancy. That mix of Omega 3 fats did not eliminate the hypolipidemia but it ensure she did not develop pancreatitis again. The big question for consumers is whether the $200 a month for Vascepa is that much better than simply taking fish oil supplements?

The market is voting with its feet and the shares of Amarin jumped higher today. Some consolidation is likely but it is quite rare to have a new drug with wide appeal which is also likely to have wide coverage by insurers so the breakout is likely to be sustained.