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CareNet, Inc. and the Department of Public Health, University of Occupational and Environmental Health, conducted a survey to “understand the background and characteristics of patients prescribed PCSK9 inhibitors for high cholesterol treatment” using receipt data from the National Health Insurance and Late-Stage Senior Citizen’s Health Care System. The results were published as an academic paper titled ” Survey of PCSK9 inhibitor prescribing status using the claim data,” and was published in a medical journal, “Journal of the National Institute of Public Health,” in December 2023.
This is a real-world data (RWD) study in which a descriptive survey was conducted to understand the background and characteristics of patients prescribed PCSK9 inhibitors for the treatment of hypercholesterolemia using receipt data from the National Health Insurance and Late-Stage Senior Citizen’s Health Care System of three municipalities where permission to use the drug was obtained.
From the six years of receipt data (April 2015 to March 2021), the group of patients for whom PCSK9 inhibitors were first prescribed during the period April 2017 to March 2020 was identified as the “PCSK9 group” (184 patients), and the same procedure was used to determine the control group as the “ezetimibe maximum tolerated dose statin combination group” (1,307 patients).
The study results revealed a higher prevalence of ischemic heart disease and a higher proportion of patients undergoing PCI surgery in the PCSK9 group compared to the ezetimibe maximum tolerated dose statin combination group during the post-index period (12 months from the date of first prescription) after initiation of treatment. During the pre-index period (12 months prior to the date of first prescription), the prevalence of ischemic heart disease and the proportion of patients undergoing PCI were higher in the PCSK9 group compared to the ezetimibe maximum tolerated dose statin group, suggesting that PCSK9 tends to be used in high-risk patients who are at increased risk for recurrent acute myocardial infarction. Accordingly, the results demonstrate that PCSK9 are more frequently prescribed for high-risk patients who face an elevated risk of recurrent acute myocardial infarction.
Additionally, 44.6% of patients discontinued PCSK9 inhibitors within one year, the period after PCSK9 inhibitor treatment was started, indicating the possibility that the financial burden of PCSK9 inhibitor treatment on the part of patients and hesitation on the part of healthcare providers to select expensive drugs for prophylactic purposes may have occurred.
Coronary artery disease is one of the major causes of death in Japan. Acute myocardial infarction occurs in approximately 74,431 people per year, and data show that approximately 27-40% of these patients have recurrent cardiovascular events within 3 years of treatment; hence, prevention of recurrent events is a critical issue in Japan, an aging society. For drugs with novel mechanisms of action (e.g., PCSK9 inhibitors), which have high potential for preventing recurrent coronary artery disease, studies such as the present one are expected to identify patients who will benefit from appropriate drug pricing and cost-effectiveness.
About the paper:
Title: Survey of PCSK9 inhibitor prescribing status using the claim data
Authors name: TOKUTSU Kei, ITO Kaoru, KAWAZOE Shigeki, FUJIMOTO Kenji, MATSUDA Shinya
Journal: Journal of the National Institute of Public Health
URL：https://www.niph.go.jp/journal/data-72-5-j72-5/
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