Abstract 12945: Six-Month Adherence Among Early Inclisiran Initiators vs. Anti-PCSK9 mAbs Users: A Retrospective Analysis of US Claims Databases

Introduction: Poor adherence with statins is an obstacle in achieving LDL-C targets for patients with atherosclerotic cardiovascular disease (ASCVD). Inclisiran is a first-in-class, long-acting, small-interfering RNA approved as an adjunct to diet and maximally tolerated statin for adults with ASCVD or heterozygous familial hypercholesterolemia who require additional LDL-C lowering. It is initially administered subcutaneously by an HCP, again at 3 months and then twice yearly. Real-world studies assessing adherence of inclisiran are limited.

Hypothesis: This study evaluated treatment adherence at 6 months for patients who newly initiated inclisiran, alirocumab (every 2 weeks or 1/month) or evolocumab (every 2 weeks or 1/month) since 2022.

Methods: This retrospective, observational study utilized the US Komodo Health database from 1/1/21 - 2/8/23. Komodo Health is a nationally representative longitudinal database that captures 330 million patients in the US from open and closed administrative databases. Patients were aged ≥18 years, had 12 months of continuous enrollment (CE) before the index date, 6 months CE after the index date and a first claim for inclisiran, alirocumab, or evolocumab in the identification period (1/1/22 - 10/31/22). Adherence was defined as the proportion of days covered (PDC): the number of days covered by the drug divided by the observational period (6 months after index date). Poor adherence was defined as PDC <80%.

Results: A total of 981 patients had ≥6 months of CE after the index date and were in the inclisiran cohort;11,330 patients were in the alirocumab cohort and 30,515 in the evolocumab cohort. Mean (SD) 6-month adherence was highest for inclisiran at 0.85 (0.22) followed by 0.72 (0.30) for alirocumab and 0.70 (0.30) for evolocumab. The proportion of patients with high adherence (PDC ≥0.8) was 69.9% for inclisiran, followed by 51.0% for alirocumab and 48.6% for evolocumab. Of patients in the inclisiran cohort (n=981), 70.9% received a second dose with a mean time of 90.9 (32.0) days between doses.

Conclusions: Early evidence post launch shows patients initiating inclisiran had higher adherence vs anti-PCSK9 mAbs. Inclisiran is a new option for patients with ASCVD who may have difficulty reaching their LDL-C target.