Coverage and Cardioprotective Benefits of PCSK9 Take Center Stage at the American College of Cardiology Meeting.

Abstract

With news breaking at the American College of Cardiology’s Annual Scientific Session that evolocumab lowered cardiovascular events compared with placebo but did not reduce deaths in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), the debate about the place of PCSK9 (proprotein convertase subtilisin–kexin type 9) inhibitors in practice and their high price is unlikely to end soon. The highly anticipated results showed a 15% reduction in cardiovascular events, and results from a sister trial showed no increase in neurocognitive problems, providing much needed information for clinicians using this drug in their practices. But the results, which were less favorable than many hoped, are unlikely to resolve the ongoing challenges posed by the high cost of this class of drugs and the reticence of payers to cover it. “This drug presents challenges to the health system,” said Harlan Krumholz, MD, SM, a cardiologist and health policy researcher at Yale University. “It is effective, but not miraculous. The benefit will seem substantial to some and modest to others, like many preventive interventions, but, in this case, there is the added issue that the cost is high.” Data showing that PCSK9 inhibitors evolocumab and alirocumab could slash low-density lipoprotein levels led to US Food and Drug Administration approval for both drugs in 2015. But the drugs, which are approved for patients with familial hypercholesterolemia or high-risk …