Optimal follow-up schedule for patients taking PCSK9 monoclonal antibodies in a health system: Analysis of specialty pharmacy clinical interventions

Abstract

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Purpose: The objective of this study was to determine if and when it is clinically appropriate to consider a reduction in the frequency of health-system specialty pharmacy (HSSP) clinical pharmacist assessments for patients taking a proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody (mAb) after they are deemed clinically stable on therapy.

Methods: A single-center, retrospective, observational study of adult patients on PCSK9 mAb therapy enrolled in the University of Rochester Specialty Pharmacy Cardiology Patient Management Program was performed between October 24, 2016, and April 30, 2022. The primary outcome was the number of clinical pharmacist interventions per interval within the baseline 12 months compared to 12-month intervals for up to 72 months after initiation of PCSK9 mAb therapy.

Results: A total of 368 patients on PCSK9 mAb therapy were included in the study. A significantly lower percentage of patients had more than 2 interventions during the 12- to 24-month interval (24.3%) as compared to the baseline 12-month interval (80.2%) (P < 0.001); this represented a 70% reduction in the chance of a patient requiring more than 2 interventions (relative risk, 0.30; 95% CI, 0.24-0.38). A similar trend was demonstrated in the 24- to 36-month and 36- to 48-month intervals when compared to the first year of therapy. The most commonly documented clinical pharmacist interventions were the categories of safety (29.2%), effectiveness (28.4%), and adherence (19.9%).

Conclusion: Patients beyond 1 year of PCSK9 mAb therapy required less clinical pharmacist interventions. Therefore, stable patients receiving a PCSK9 mAb may be considered for less frequent clinical assessments to allow for HSSP growth to nontraditional clinical areas.

Keywords: ambulatory care; cardiovascular disease; clinical pharmacy services; health-system specialty pharmacy; hypercholesterolemia; specialty lite.