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

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 in 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.

Evaluation of a Hepatitis C Patient Management Program at a University Specialty Pharmacy.

BACKGROUND: The University of Rochester (UR) Specialty Pharmacy hepatitis C patient management program offers a unique advantage of being integrated within the same health system as the University of Rochester Medical Center (URMC) Gastroenterology and Hepatology division. OBJECTIVE: The primary purpose of this study was to assess treatment success through the incidence of achieving a sustained virological response (SVR) in patients served by the UR Specialty Pharmacy versus other nonintegrated pharmacies. METHODS: This was a single-center retrospective cohort study in adult patients of URMC Gastroenterology and Hepatology prescribed hepatitis C treatment between January 1, 2014, and July 15, 2015. The incidence of SVR, adherence, delay in therapy initiation, early treatment discontinuation, rate of attainment of viral load measurement post-therapy completion, and predictors associated with treatment outcome were assessed. RESULTS: A total of 414 patients were prescribed hepatitis C virus treatment during the study period; 137 did not initiate therapy. The rate of SVR was 93% among patients at the UR Specialty Pharmacy and 89% at nonintegrated pharmacies ( P = 0.357). Adherence to therapy was 100% and 97% at the UR Specialty Pharmacy and nonintegrated pharmacies, respectively ( P = 0.046). CONCLUSIONS: The UR Specialty Pharmacy was associated with a 93% SVR rate and significantly greater adherence compared with nonintegrated pharmacies. Larger studies are needed to determine if a significant difference in SVR exists between integrated and nonintegrated pharmacies. This study provides a framework for other institutions to justify developing integrated hepatitis C specialty pharmacy services and evaluate their success.