How Cost-Effectiveness of Cholesterol-Lowering Drugs Impacts New Guidelines

In the second installment of this series, Michael Miller, MD, professor of cardiovascular medicine at the University of Maryland School of Medicine, discusses the cost-effectiveness of PCSK9 inhibitors. He explains how the costs of PCSK9 inhibitors impact cholesterol therapy guideline recommendations and he also discusses how costs affect how PCSK9 inhibitors are used in practice.

Transcript:

First Report Managed Care:  How does the cost effectiveness of PCSK9 inhibitors impact cholesterol therapy guideline recommendation, and how does that affect how PCSK9 inhibitors are used in practice?

Dr Miller:  I think you're looking at high-risk individuals, and it was an analysis done at the American Heart in the ODYSSEY trial. This was using the PCSK9 inhibitor, alirocumab.

What they found was that if you bring the level down, the number down to treat...The number, for example, I think it was somewhere between $5,000 and $8,000, in that high-risk group who had an LDL above 100 despite statin therapy, then it would be viewed as a cost-effective strategy.

At $15,000, it's not viewed as cost effective, but if it's brought down below that, which I understand the company is now doing, if you bring it down to about $8,000 give or take, then it's viewed to be more cost effective.

First Report Managed Care:  Can you comment a little more about the ODYSSEY outcomes results and what you think the overall impact might be for the future?

Dr Miller:  Yeah. ODYSSEY took patients that had an experience in acute coronary syndrome and then monitored them. They were all placed on statin therapy, and on top of the statin, a half of group received active PCSK9 inhibitor.

What the ODYSSEY found was that it met its primary endpoint with a 15 percent reduction in cardiovascular events, so that was actually a pretty important cut-point.

It also showed some benefit, in secondary studies, of survival. In secondary analysis, not as a primary analysis, but a secondary analysis. Interestingly, they found was, the benefit was primarily shown in individuals that started off with a baseline LDL of greater than 100.

You got the most bang for your buck if your LDL was greater than 100, rather than if you started like with an LDL of 50, or 60, or 70. That suggests that the patient group more likely to benefit with the use of this therapy were those high-risk patients, on top of the statin, who had an LDL of at least 100.

First Report Managed Care:  How does the value equation for PCSK9 inhibitors differ for different groups of patients, for example those of higher cholesterol levels or greater cardiovascular risk?

Dr Miller:  The studies, to date, with the PCSK9 inhibitors have focused in those with established disease, in other words, reducing recurrent events. We don't have a whole lot of data on patients in primary prevention.

By and large, the studies show benefit in people with established disease. We prescribe them in patients that have genetically high LDL because of their very high risk of a first event. It's used as a high-risk primary prevention if they have familial hypercholesterolemia, but by and large, it's also now used on those patients who have an LDL that is still elevated.

The guidelines now will recommend if you have a high risk of disease, you could use a PCSK9 inhibitor if your LDL is above 70.

I think we're going to see a lot more patients that will be on this therapy if you cannot get their LDL levels down with a statin, or we will see a lot of patients that have some degree of statin intolerance, that they can't get their LDL levels down effectively because of that reason, and will need a PCSK9 inhibitor.

First Report Managed Care:  Amgen announced last month that they were lowering their price of Repatha. Do you foresee more drug companies to lower their cost in the future, following the announcement from Amgen?

Dr Miller:  The injectable, the monoclonal antibodies, perhaps. These are very expensive to make. These are much more expensive than pills, these injectables, though it is true that you only need to use the injections once or twice a month.

The medicines company has another injectable that only needs to be used, I think, every three to six months, so that would even be less numbers of injections needed over the course of a year.

If they do lower the price, as they said they're going to do, to $5,000 to $8,000 a year, that, I think, will, in this class of agents, make things a whole lot more competitive.

In pill form, if you look at a medicine like VASCEPA that's currently about $250 a month, that's only $3,000 a year. Even if the PCSK9s go down to $6,000 or $8,000 a year, it's still going to be significantly less than the PCSK9 inhibitor.