LAUSR

See Article by Doshi et al In this issue of Circulation: Cardiovascular Quality and Outcomes , Doshi et al1 raise the issue of whether the prior authorization (PA) program requirements are particularly excessive for the proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) drug class. The authors report on the burden of the PA process for PCSK9i using a unique proprietary database that includes detailed information on PA requirements for 3872 public and private insurance plans. They found that there were greater PA requirements for PCSK9i than for other brand name cardiometabolic drugs used as comparators (ezetimibe, liraglutide). Although it is often expected that government bureaucracy exceeds that in the private sector, this study found that in contrast, it was the non-Medicare plans that had 3× to 11× more fields required for PA form completion than comparator drugs. In particular, health insurance exchange plans established by the Affordable Care Act had the highest burden of criteria to fulfill the PA submission process. A high-burden PA process may be related to high rates of rejection for submitted PCSK9i prescriptions because other studies have reported that commercial payers also had the lowest PA approval rates.2,3 Why are we examining the intricate details of the PCSK9i PA process and high rejection rates? The reason is clear—simply put, these drugs are expensive and at a level not previously seen for a drug with this potentially large of a market. This is the elephant in the room. Cost-effectiveness analyses of PCSK9i have not been favorable. Multiple studies using a variety of sensitivity analyses and approaches all suggest that annual PCSK9i costs must be reduced by 60% to 70%, down to $4000 to $5000 …