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A cardiologist asks: How much is too much to pay for a promising drug?

The advertising campaign suggests Amarin has an agenda. By going directly to patients through advertising that does not mention the cost, the implication is that the cost is irrelevant.

This undated photo provided by Amarin in November 2018 shows a capsule of the purified, prescription fish oil Vascepa. On Friday, Dec. 13, 2019, U.S. regulators approved expanded use of the medication for preventing serious heart complications in high-risk patients already taking cholesterol-lowering pills.
This undated photo provided by Amarin in November 2018 shows a capsule of the purified, prescription fish oil Vascepa. On Friday, Dec. 13, 2019, U.S. regulators approved expanded use of the medication for preventing serious heart complications in high-risk patients already taking cholesterol-lowering pills.Read more

There is a new advertising campaign for a high-priced medication that has caused me an ethical dilemma.

You may have seen a television ad about Vascepa, which in a recent study called REDUCE-IT was able to decrease the chance of having a heart attack or other cardiac event by 25%. This finding applied specifically to people who have high triglycerides (a kind of fat in the blood), have lots of risk factors for heart disease, and who are already taking a statin medication to lower their cholesterol. When this study came out in 2018, it was huge news as this was the first time that a kind of fish oil has been proven to lower cardiac risk.

The company that makes Vascepa, called Amarin, has priced it at about $355 a month.

This is not an outlier. In cardiology, the cholesterol lowering drugs Repatha and Praluent came under pressure because they were so expensive. Most formularies have restricted their use, and the prices have started to come down.

The case of Vascepa seems different. There has been a move by Amarin to promote its product by distinguishing it from its competitors. Unfortunately, there are hundreds of brands of fish oil available both by prescription — including generics — and over the counter.

This has become a little nasty, as I experienced several weeks ago when I wrote an article for The Inquirer, in which I cited Vascepa as one of the top 10 advances in cardiology in 2019, called it a type of fish oil, and mentioned cost as a concern.

I received many emails similar to the one below, seemingly coordinated, almost to the word.

Mr Becker,

Perhaps you should read the study you cited in your cardiologist piece (REDUCE-IT). Vascepa is not a brand of fish oil.

It is a new chemical entity.

The form of EPA in Vascepa occurs in nature as much as plutonium occurs in nature. In other words, it doesn't.

As a journalist, you should have some sort of responsibility to the readers to be truthful.

I do have a responsibility to readers. The truth is Vascepa is derived from fish oil. It is icosapent ethyl, 100% EPA. EPA (Eicosapentaenoic acid) and DHA (Docosahexaenoic acid) are called omega 3 fatty acids. These are the two main active ingredients in fish oil, and most preparations are 50/50 DHA/EPA. It looks like the EPA component in Vascepa may be especially effective in lowering cardiac risk.

The problem: the cost, which is significantly higher than other prescription or over-the-counter brands on the market. I have prescribed Vascepa many times since the REDUCE-IT trial was published, and most times the insurance companies have denied it as there were other generic medications available that the insurance company decided were equivalent. Many patients have told me that at $355 a month, they will not pay.

Who is accountable? Is it Amarin, which set the price high? The insurance companies that do not want to pay for it despite evidence that it works? The doctors who may be reluctant to prescribe it or fight to get it for their patients no matter what the cost? Or the patients who are not willing to pay for it?

The advertising campaign suggests to me that Amarin has an agenda. By going directly to patients through advertising that does not mention the cost, the implication is that the cost is irrelevant. They offer coupons to defray the cost to help, but this is not the answer as people over age 65 are excluded (the deal doesn’t work with Medicare).

Why is it so expensive? After all, it is a pure form of fish oil, not plutonium. The cost of conducting a large trial such as REDUCE-IT is high, in the hundreds of millions. The company needs to be able to recover its costs while the drug is on patent. It should be able to make a profit. How much is too much?

This brings me back to my ethical question. Should I be fighting to help patients get this particular brand of medication because a large study suggests it may be better for people with heart disease and high triglycerides, no matter what the cost? I do not know the right answer. But, as more and more highly priced drugs come on the market, we will need to come up with a better strategy than expensive advertising campaigns.

David Becker is a frequent Inquirer contributor and a board-certified cardiologist with Chestnut Hill Temple Cardiology in Flourtown, Pa. He has been in practice for 25 years.