Features June 2017 Issue

PCSK9 Drugs Emerging as Strong Cholesterol-Lowering Agents

Recent research touts the effectiveness of PCSK9 inhibitors, but their price may remain an obstacle for many people.

Since the cholesterol-lowering drugs PCSK9 inhibitors were first approved by the U.S. Food and Drug Administration (FDA) two years ago, there has been considerable curiosity about just how effective they can be, and whether they will be affordable for the average consumer.

An answer to questions about the impact of PCSK9 inhibitors on cholesterol was provided earlier this year at the American College of Cardiology Scientific Sessions conference. In short, the PCSK9 inhibitor evolocumab (Repathaź) performed quite well in a two-year study involving more than 27,000 patients. Those taking the drug in addition to standard statin therapy experienced a 25 percent reduction in cardiovascular death, heart attack and stroke after the first year.

Clogged Artery

© Skypixel | Dreamstime.com

Cholesterol plaque forms inside arteries, narrowing the flow of blood. Cholesterol-lowering drugs, such as statins and PCSK9 inhibitors, slow that formation.

But what was even more striking was just how much the drug helped lower the LDL (“bad”) cholesterol levels in the study participants. The average LDL level at the start of the study was 92 mg/dL. By the end, the average was around 30 mg/dL. And those who started out in the lowest LDL group—an average of 74 mg/dL—saw a reduction down to 22 mg/dL.

“Any time you see a drug given on top of statins that reduces morbidity and mortality to that degree, it’s a big deal,” says Steven Nissen, MD, chairman of the Department of Cardiovascular Medicine at Cleveland Clinic. “We’ve had statins for 30 years, so we know how they work. We’re still learning about these new drugs. One thing that came out of this study was that the benefit is a lot more in the second year than the first.”

Drugs’ Cost Limits Availability

Despite all the encouraging study results, one undeniable fact is keeping evolucumab and another PCSK9 inihibitor, alirocumab, out of reach for most consumers. The drugs, which must be injected either every two weeks or once a month, cost about $14,000.

There has been some movement among insurers to cover PCSK9 inhibitors for a select group of patients. Evolucumab, for instance, is approved by the FDA for use in patients with atherosclerosis or very high cholesterol, and who cannot get their LDL cholesterol under control with aggressive statin therapy and lifestyle changes.

But many U.S. insurers aren’t ready to cover the costs of PCSK9 inhibitors. At issue is whether the added benefit of a drug like evolocumab is deemed worthy of coverage. Insurers appear to believe that statin therapy usually provides sufficient LDL reduction. Cardiologists know that they can save lives and delay events such as heart attack and stroke in patients by prescribing PCSK9 inhibitors. Conversations between healthcare providers and policy makers are ongoing.

Dr. Nissen says that these issues will be worked out by all the parties involved in the months and years ahead. He’s encouraged that these drugs will eventually become common add-ons to statin therapy, in part based on research like that presented at the conference. “I do believe this study is going to move the needle,” he says. “More people will become eligible for this drug. The most important thing is that we know lowering LDL levels cuts the risk of heart attack, stroke and cardiovascular death, and we know how to get patients to those levels.”

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