Impact of specialty pharmacist involvement on patient access to PCSK9 inhibitors

Abstract

Background: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are novel antilipemic agents commonly associated with barriers to access for patients. They are indicated as adjunctive therapy for the treatment of heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, and atherosclerotic cardiovascular disease needing additional low-density lipoprotein cholesterol (LDL-C) lowering. On average, annual therapy costs total approximately $14,000 per year. Due to high cost and specific indications, rates of prescription coverage denial are high for patients prescribed these medications with approximately 50% of prescriptions ultimately being rejected.Objectives: The purpose of this study is to demonstrate the impact of specialty pharmacist involvement on patient access to PCSK9 inhibitors.Methods: This was a retrospective study of patients over the age of 18 who were prescribed a PCSK9 inhibitor by a Medical University of South Carolina (MUSC) provider, with additional training in lipid management or cardiology, from 1 January to 30 June 2017. Patients were excluded if they were actively enrolled in a clinical trial at the time of PCSK9 inhibitor prescribing, or they were pregnant or lactating.Results: A total of 76 prescription orders were included in the analysis. The results were divided into three categories and compared to industry standards via chi-squared goodness of fit tests. Overall, 34/38 (89.5%) prescriptions were eligible to be filled at MUSC, statistically significantly higher than the expected 30.9% overall fill rate (p < .001). Additionally, 50/57 (87.7%) of prescriptions requiring a prior authorization (PA) and sent to MUSC received approval, statistically significantly higher than the expected 47.29% approval rate (p < .001). Lastly, 28/31 (90.3%) of patients received medication and a PA, statistically significant compared to 65.3% expected (p = .003). Regarding clinical outcomes, 35/38 patients (92.1%) in the MUSC eligible fill group did not have an unplanned cardiovascular-related emergency department visit or admission.Conclusions: As specialty pharmacy continues to grow and diversify, costly medications, like PCSK9 inhibitors, will continue to require added steps to obtain them. In this study, dedicated specialty pharmacists increased patient access to PCSK9 inhibitors by 58.6% compared to expected. This not only demonstrated improved quality of care, but also positive impacts on clinical outcomes, especially in patients who maintain the continuum of care through the health system.