PCSKI9 inhibitors need a 62% lower price tag to make them affordable

It’s well-established that cholesterol-lowering PCSK9 inhibitors (PCSK9i) are a pricey addition to any heart patient’s medication regimen, climbing to more than $14,000 per year at retail value and $5,000 in out-of-pocket costs—but they are effective.

Taking PCSK9i drugs, in addition to a regimen of statins, has been proven to reduce the probability of adverse cardiovascular events in at-risk patients and lower low-density lipoprotein (LDL) cholesterol dramatically. New information from the Further Cardiovascular Outcomes Research with PCSK9 Inhibitors in Subjects with Elevated Risk (FOURIER) trial indicated that adding a PCSK9i known as evolocumab to a cardiovascular patient’s statin routine reduced rates of major adverse cardiovascular events per year by 15 percent and lowered LDL cholesterol by 59 percent.

The cost of evolocumab is still a concern—reaching $14,300 per year—but the FOURIER trial sheds light on how effective the medication is, and whether it’s worth the high price tag, Khurram Nasir, MD, MPH, and colleagues wrote in a JAMA Cardiology report.

“Recent studies assessing cost-effectiveness over a lifetime of treatment at current drug prices have shown that PCSK9i drugs were expensive from a health system perspective and were above the societal threshold of $100,000 per quality-adjusted life-year,” the authors wrote.

Nasir and his team used a Markov model to complete a cost-effectiveness analysis of statin regimens alone and statin regimens with added PCSK9 inhibitors. They found the incremental cost-effectiveness ratio of the latter to be $337,729 per quality-adjusted life-year, as calculated with 2016-value American dollars.

For 86 percent of private payers, the authors wrote in their report, the addition of PCSK9i to statin therapies alone resulted in a negative return on investment. Nasir and colleagues calculated that, since adding PCSK9i to statin therapy resulted in a price three times the commonly accepted willingness-to-pay threshold, manufacturers would need to reduce the price of PCSK9 inhibitors by 62 percent, to $5,459 per year.

Until these prices are reduced, the researchers wrote, PCSK9 inhibitors will be financially unviable for cardiac patients.

“Our study provides critical insights on the break-even price for private payers, which is extremely relevant for the U.S. private, multipayer insurance market,” they wrote. “Our findings suggest that even greater discounts will be necessary for PCSKI9i to be a financially sound investment for insurers. Because private payers might face the majority of the up-front investment but only a fraction of the long-term benefits, extensive deliberations are needed to identify the right financial incentives to overcome access barriers to these emerging interventions.”