In many areas of health care, insurers are increasingly tying reimbursement to patient outcomes to promote accountability for care. However, biopharmaceuticals have largely been divorced from these efforts, despite their growing use and high costs. This model must change for 2 reasons. First, there is a wave of new biopharmaceuticals to treat common, costly chronic diseases; second, there is uncertainty about their real-world efficacy. Without new pricing models, insurers and manufacturers will remain at odds about reimbursement, leaving physicians and patients stuck in the middle.
Perhaps nowhere is this issue more salient than with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, a new class of monoclonal antibody lipid-lowering therapies. Two PCSK9 inhibitors—alirocumab and evolocumab—have been approved for treatment of patients with atherosclerotic cardiovascular disease (ASCVD) or familial hyperlipidemia with suboptimally controlled low-density lipoprotein cholesterol (LDL-c) levels despite maximally tolerated lipid-lowering therapy (1). PCSK9 inhibitors reduced LDL-c levels by 50% to 75% in clinical trials (2), and a meta-analysis suggests that they may reduce major adverse cardiovascular events by up to 50% (3).
Authors: DP Goldman, A Jena, et al
Source: Annals of Internal Medicine
Publication Year: 2016