KEY IDEA: Amarin feels that adding salespeople might be the answer to make Vascepa a blockbuster. They are also ramping up TV ads in support but will it make a difference?
Amarin’s CEO John Thero said a doubled salesforce was almost in place and ready to capitalize on the FDA’s label expansion of Vascepa in December to include a risk reduction of cardiovascular events in patients with abnormally high triglycerides. But that’s not the answer.
The FDA approved Vascepa as an add-on to statins to reduce the risk of cardiovascular events in patients with elevated triglycerides who have either established CV disease or diabetes with two additional CV risk factors.
The expanded approval for prevention of events including heart attacks and strokes isn’t quite as broad as Amarin hoped. Payers may embrace the drug for its relatively low cost and ability to prevent costly cardiac events. Still, the fact that it could reach tens of millions of patients and cause a near-term jump in spending may lead them to throw up barriers to access.
The real problem, however, maybe convincing cardiologists. About one in five American adults take fish oil capsules, often because they have been told it can help prevent a heart attack or even treat coronary artery disease. People also take it for other reasons, such as arthritis and depression. Eating enough fish is hard to do, so many doctors’ advice has always been to take the pill and get the same benefits.
A study, in JAMA Cardiology, went even further. This meta-analysis (a review of all large fish oil trials done to date) showed no payback of any kind in preventing heart attacks, strokes, or heart-disease-related death in the more than 77,000 high-cardiac-risk individuals who participated in 10 large clinical trials.
Bottom line: Without evidence that they prevent heart attacks in those with no history of heart disease, or prevent further problems in high-risk individuals, it is hard to support the routine use of this supplement.
In addition, there are several prescription fish oils. Some are now generic, have the advantage of being approved by the U.S. Food and Drug Administration, are rich in DHA and EPA, and are purified. They are often not covered by many prescription plans and can be expensive.
The real test, however, is whether insurance companies will make Vascepa readily available with a low copay. Right now Medicare patients could pay over $200 a month for Vascepa.
With all these non-prescription sales of fish oil sales are soaring. Sales are up in double digits. To consumers, OTC fish oil may be a shorter way to get the benefits of fish oil without going to their doctor’s office.