PCSK9 Inhibitors: Economics and Policy.

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors substantially reduce low-density lipoprotein cholesterol, but it is presently unclear whether they also reduce mortality. The list prices of PCSK9 inhibitors in the United States (>$14,500 per year) are >100× higher than generic statins, and only a small fraction of their higher cost is likely to be recovered by prevention of cardiovascular events. The projected cost effectiveness of PCSK9 inhibitors does not meet generally accepted benchmarks for good value in the United States, but their value would be improved by substantial price reductions. For individual patients, the high out-of-pocket costs of PCSK9 inhibitors may impede access and reduce long-term adherence. The budgetary impact of PCSK9 inhibitors would be very large if all potentially eligible patients were treated, which poses dilemmas for policymakers, payers, and society.