Survey of PCSK9 inhibitor prescribing status using the claim data

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  • レセプトデータを活用したPCSK9阻害薬の処方実態に関する調査
  • レセプトデータ オ カツヨウ シタ PCSK9 ソガイヤク ノ ショホウ ジッタイ ニ カンスル チョウサ

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Abstract

<p>Objectives: We conducted a descriptive survey using claim data from the National Health Insurance and the Late-Stage Senior Citizen's Health Care System of three municipalities where permission for use was obtained to understand the background and characteristics of patients prescribed PCSK9 inhibitors for hypercholesterolemia. Patients prescribed statin maximum tolerated dose and ezetimibe combination, the phase before PCSK9 inhibitor initiation on the guidelines were also extracted as reference.</p><p>Methods: Based on the claim data from April 2015 to March 2021, we defined the “PCSK9 group” as patients who were not prescribed a PCSK9 inhibitor from April 2016 to March 2017 and were first prescribed a PCSK9 inhibitor between April 2017 and March 2020. Ezetimibe with maximum-tolerated dose statin was also selected by the same procedure and defined as the “ezetimibe maximum-tolerated statin group”. We also compared the two groups in terms of lifestyle-related medications, cardiovascular events, and coronary catheter intervention (PCI) procedures observed in the 12 months before (pre-index) and 12 months after (post-index) the start date.</p><p>Results: There were 184 subjects in the PCSK9 group (mean age 74 years, 57.1% male) and 1,307 subjects in the ezetimibe maximum-tolerated statin group (mean age 71 years, 60.5% male). A comparison of the changes in medical care and treatment status before and after the index date (pre-/post-index period) showed no significant difference in the pre-index period but a higher rate of ischemic heart disease in the PCSK9 group in the post-index period (85.3% vs 76.1%, p=0.005). For PCI, the PCSK9 group had a significantly higher proportion of patients who underwent surgery than the ezetimibe maximum-tolerated statin group in both the pre-/post-index periods (pre-index period: 40.8% vs 24.0%, p<0.001; post-index period: 13.6% vs 8.1%, p=0.014), (post-index period: 13.6% vs 8.1%, p=0.014). Prescription discontinuation was observed in 44.6% of patients in the PCSK9 group but not in the ezetimibe maximum-tolerated statin group.</p><p>Conclusion: Analysis of the claim data showed that PCSK9 inhibitors were used in higher-risk patients than ezetimibe with maximum-tolerated dose statin. The rate of discontinuation of PCSK9 inhibitors was high (approximately 45%). Although a causal relationship cannot be established, it is suggested that patients may have been burdened financially by PCSK9 inhibitor therapy and providers to hesitate in using the expensive drugs for prophylactic purposes. High-cost medications for treating high cholesterol are expected to be launched shortly. Further studies to identify cost-effective patients and more appropriate drug prices are expected.</p>

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