Treatment Patterns Among Early Inclisiran vs Anti–PCSK9 mAbs Users: A Retrospective Analysis of US Claims Databases

Abstract

Study Funding

This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ. The funding source was involved in study design, data analysis, drafting, and approval of this abstract.

Background/Synopsis

Adherence to treatment remains an obstacle in achieving low-density lipoprotein cholesterol (LDL-C) targets. Inclisiran is a small-interfering RNA that targets PCSK9 messenger RNA and is approved as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia to reduce LDL-C in the US. It is administered subcutaneously by an HCP, again at 3 months and then twice yearly. Real-world studies assessing treatment patterns of inclisiran are limited.

Objective/Purpose

This study assessed adherence and persistence at 12 months among patients who newly initiated inclisiran, alirocumab (every 2 weeks or 1/month) or evolocumab (every 2 weeks or 1month).

Methods

This retrospective, observational study utilized the US Komodo Health database from 1/1/21–8/31/23. Komodo Health is a longitudinal database that captures 330 million patients in the US from open and closed databases. Patients were ≥18 years, had 12 months of continuous enrollment before and after the index date and a first claim for inclisiran, alirocumab, or evolocumab between 1/1/22–8/31/22. Adherence was measured by the proportion of days covered (PDC): number of days covered by the drug divided by the 12-month observational period. Discontinuation was defined as a gap of >60 days for alirocumab and evolocumab, and >90 days for inclisiran between the last day of days’ supply and the start of the next prescription. Days of supply (DOS) for inclisiran was assumed to be 92 days for the 1st dose and 183 days for the subsequent doses. Sensitivity analysis was performed by extending DOS by 30 and 90 days for inclisiran to reflect the flexibility in dosing schedule.

Results

A total of 852 patients were included in the inclisiran cohort; 8,878 patients in alirocumab and 27,171 in evolocumab cohort. Mean (SD) PDC at 12-month was 0.77 (0.28), 0.68 (0.33) and 0.67 (0.33) for inclisiran, alirocumab and evolocumab, respectively. The proportion of patients who discontinued the therapy was 31.6%, 44.8% and 45.3%; mean (SD) time to discontinuation was 133.52 (71.32), 119.22 (79.99), and 113.7 (80.41) days, respectively. When DOS for inclisiran was extended by 30 or 90 days, mean PDC was 0.82 (0.25) and 0.90 (0.20), respectively; discontinuation was 22.9% and 19.8% and time to discontinuation was 135.5 (37.4) and 183.1 (10.0) days, respectively.

Conclusions

Inclisiran had significantly higher adherence and lower rates of discontinuation vs. anti-PCSK9 mAbs at 12-month after initiation. Convenient dosing of inclisiran may be an option for patients who requires additional LDL-C lowering.