By now you’ve read the headlines about the high cost of the new cholesterol lowering drugs. We’ve been bombarded with commentary, articles and opinion pieces on these drugs and their high prices. The PCSK9 inhibitors – injectable, biologic drugs that dramatically lower LDL-cholesterol – appear to be very efficacious. But these drugs are priced at more than $14,000 per year, and will be used by patients for the rest of their lives. For someone who starts taking these drugs in their 50s, the lifetime cost could reach $400,000, rivaling the annual cost of the most expensive orphan drugs.
We have a big problem here in the U.S. Cardiovascular disease is still the number one cause of death despite the wide availability of effective medicines, such as statins. Someone in the U.S. dies every 45 seconds from cardiovascular disease – that’s 800,000 people each year.
Too many of us are still dying from cardiovascular disease. Almost 40 million people in the U.S. have elevated LDL-cholesterol levels, and we know that if you lower LDL-cholesterol in people with elevated LDL-C levels you may reduce the risk that they die from cardiovascular disease. In fact, clinical trials show that lowering LDL-cholesterol by around 40 mg/dL results in a 20 percent reduction in cardiovascular disease risk.
The biopharmaceutical industry has grown through, and been sustained by, consistent innovation. Those of us with the ideas, expertise, and resources are called to help – to innovate – to develop new therapies for people who have high LDL-cholesterol levels. PCSK9 inhibitor drugs are an amazingly innovative new class of therapy. But they are expensive and our healthcare system will struggle to bear the cost of millions of people taking these drugs for the rest of their lives.
So we need to shift our focus to cost-effective innovation. At Esperion we are developing a therapy for lowering LDL-cholesterol – bempedoic acid – currently in late stage clinical development. If approved, bempedoic acid will be a convenient, once-daily pill. It works in combination with other LDL-cholesterol lowering drugs, most of which are already generic, and will be a relatively low-cost option. This is an example of the cost-effective innovations our country needs.
It isn’t enough anymore for innovative new drugs to be efficacious, safe and well tolerated. True innovation has a new definition: the right drug, at the right price, for the right patient.