1. Characteristics Associated with Inclisiran Initiation in Outpatient Physician Clinics.
- Author
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Ballantyne, Christie M, Van Anglen, Lucinda J, Varisco, Tyler J, Graham, Timothy E, Iteld, Bruce J, Serota, Harvey, McElligott, Sean, and Niu, Xiaoli
- Subjects
ANTILIPEMIC agents ,CONFERENCES & conventions ,TREATMENT effectiveness ,PHYSICIANS ,DRUG utilization ,OUTPATIENT services in hospitals - Abstract
Inclisiran is a novel RNA agent that prevents production of PCSK9 protein, thus lowering concentrations of PSCK9 and LDL-C. It is administered subcutaneously twice yearly, potentially reducing burden of administration in comparison to PCSK9 monoclonal antibodies (mAbs). Despite this advantage, earlier studies have found that prior authorization requirements complicate inclisiran approval in outpatient settings. Understanding patient characteristics associated with the timely initiation of inclisiran is crucial to care coordination and successful therapy nitiateon. This study aimed to identify clinical and demographic characteristics associated with successful initiation of inclisiran in outpatient infusion clinics. This was a retrospective, longitudinal cohort study of patients referred for treatment with inclisiran between February and July 2022 at 23 infusion centers in eleven states. Patients were followed until they received their first dose of inclisiran or until the time of noted non-initiation. Individuals still awaiting approval as of November 2022 were censored at that time. The Kaplan Meier method was used to estimate median time to initiation. Overall, 234 patients were referred for inclisiran initiation. The majority (55.1%) were female, 56.9% were Medicare beneficiaries, and the median age was 69 (IQR: 64-74) years. In total, 73% were referred with a primary diagnosis of atherosclerotic cardiovascular disease (ASCVD) and 5.6% with heterozygous familial hypercholesterolemia (HeFH). Through July 2022, 112 (47.9%) have successfully initiated treatment and 20 (8.6%) are pending for approval. Median time to initiation was 30 (IQR: 17-88.5) days and median time to non-initiation was 70 (IQR: 36-105). Payer denial and inability to pay contributed to 47.1% of all non-initiations. Of those who initiated treatment, 51.8% were previously treated with PCSK-9 mAbs, 65.2% had documented statin intolerance, 31.3% were prescribed concurrent statin therapy, and 31.3% were prescribed concurrent ezetimibe. Median Elixhauser comorbidity score was 6.0 (IQR: 0-14.5) with 72.3% and 34.8% having hypertension or diabetes, respectively. Median baseline LDL-C was 135 (IQR: 96-175) mg/dL. Compared to non-initiators, initiators were notably older (70.5±0.83 vs. 66.7±0.85, a higher proportion were male (61.2% vs 43.8%) and Medicare beneficiaries (52.9% vs 27.8%). Inclisiran is an accessible treatment option for patients with ASCVD and elevated LDL-C. Medicare beneficiaries were more likely to be successfully initiated due to favorable prior authorization policies. Future work will focus on measuring adherence to inclisiran and real-world effectiveness among those who successfully initiate therapy. Yes Novartis Pharmaceuticals Corporation [ABSTRACT FROM AUTHOR]
- Published
- 2023
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