Circulation. Cardiovascular quality and outcomes | 2019
PCSK9 Inhibitors Prior Authorization.
Abstract
With rising healthcare costs, emergence of novel and expensive therapeutic options has resulted in passionate debate on strategies to guide efficient use of allocated healthcare resources. In recent years, health plans in their quest to control escalating drug costs have exponentially intensified focus on utilization management policies such as prior authorization (PA). It is not surprising that this strategy is extremely unpopular in the medical community. In a sobering American Medical Association survey, nearly 9 in 10 physicians viewed PA to have negatively impacted clinic operations and efficiency at the expense of patient care and engagement.1 Studies have suggested an average of 20 hours/ week of combined time spent by clinicians and operational staff on PA-related activities with an estimated national opportunity cost of >$31 billion for all practice interactions with health plans.2 In 2015, the cardiovascular community enthusiastically welcomed FDA approval of PCSK9i (proprotein convertase subtilisin/kexin type 9 inhibitors) as an additional add-on therapeutic option for managing cholesterol-related cardiovascular disease risk. However, the celebrations were short-lived. Despite approved labeling and support by consensus statements, nearly all public and private insurers placed requirements of PA for PCSK9i in response to the initial price tag of $14 000 per year. Subsequent lukewarm support from cost-effectiveness analyses further consolidated payers’ position.3 In the last 4 years, it is now clear that these crude cost containment strategies, though effective, have not been without unintended consequences. Insights from large national insurance datasets have suggested nearly 4 initial denials for every 5 prescriptions.4 Apart from high rejection rates, it is no secret that PA obtainment and catering to specific individual health plan requirements place heavy administrative burden on clinical practices for getting ultimate approval for nearly half of these cases. For both patients and clinicians, these barriers have been disheartening because of a lack of transparency for PA determination, especially in view of our evolving understanding that targeting the highest risk subgroups may actually be a true value proposition. While it is clear that these processes add barriers to clinical care, whether the PA rejections have consequences on patient outcomes in the real world has not been well documented. In this issue of Circulation: Cardiovascular Quality and Outcomes, Myers et al5 aim to address this specific gap in knowledge. The study highlights an important point on how access to PCSK9i translates into varying health outcomes in the real world. Myers et al using a large healthcare claims dataset, provide crude estimates of potential risk for cardiovascular adverse events in patients who were rejected for or abandoned the PCSK9i prescriptions compared with those who were approved. Circulation: Cardiovascular Quality and Outcomes