Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan

Whether or not vascular endothelial growth factor pathway inhibitors (VPIs) increase the risk of artery dissection is still unknown. This study aimed to quantitatively evaluate the possibility of artery dissection as a class effect of VPIs using nationwide real‐world data. This cohort study was conducted based on the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), which spans nearly the entire Japanese population of over 100 million individuals. We included the patients prescribed with 12 types of VPIs between 2012 and 2020. The incidence rate (IR) ratio of artery dissection for each VPI were estimated in comparison with bevacizumab, the only VPI in Japan with artery dissection listed in the package insert. Artery dissection as an outcome was targeted for acute artery dissection requiring hospitalization (including dissecting aneurysm). As a reference, a natural IR standardized by sex and age of bevacizumab‐prescribed patients was also estimated using the direct method for the general population of NDB. Of 503,342 patients, the IR of artery dissection for bevacizumab was 44.4 (/100,000 person‐years), and the adjusted IR ratios for each VPI compared with bevacizumab were consistently similar to or >1.0. The IRs for each VPI were also higher than the crude natural IR (1.66/100,000 person‐years; 95% CI: 1.59–1.73) and the standardized natural IR (2.18/100,000 person‐years; 95% CI: 1.86–2.50). Real‐world evidence suggests the risk of artery dissection as a class effect of VPIs. More attention on this risk will be necessary when using VPIs in clinical practice.

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Pathway for Meaningful Use of Claim Big Data in China: An Exploratory Study of Supporting Commercial Insurance Service with Claim Big Data (Preprint)

Huang,

Guan,

Yuan

et al. 2024

Preprint

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BACKGROUND With the development of medical information technology, China has built a national unified health insurance data information platform and formed large-scale health insurance big data. The informatization level of China's healthcare industry and the value of healthcare big data are increasing. However, the development and utilization of these data are constrained by conditions such as security compliance, business models, and mission boundaries, resulting in under-exploitation and utilization of data resources. OBJECTIVE Considering that there is a research lacuna in this area, we take the lead in exploring the path of health insurance data sharing. METHODS We clarified the objects involved and their rights and responsibilities in each link of the health insurance data service based on the basis of sorting out the existing laws and regulations, organizing the relevant participants to formulate the specification of the process of health insurance big data sharing based on the Delphi method, and formulating the pricing and revenue distribution method of health insurance data service through the cost analysis method, and taking the data service of underwriting and claim settlement for the commercial insurance company as a case study to validate this study. RESULTS A case study is conducted to verify the feasibility of the proposed method in this study and to provide a reference for future health insurance data sharing and utilization applications. CONCLUSIONS By applying the proposed approach, it is both feasible and convenient to use claim big data to support commercial insurance service.

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Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan

Cited by 4 publications

References 24 publications

PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage

PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage

Risk of artery dissection during systemic exposure to vascular endothelial growth factor pathway inhibitors

Pathway for Meaningful Use of Claim Big Data in China: An Exploratory Study of Supporting Commercial Insurance Service with Claim Big Data (Preprint)

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