Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study

Sakata, Yukinori; Matsuoka, Toshifumi; Ohashi, Satoshi; Koga, Tadashi; Toyoda, Tetsumi; Ishii, Mika

doi:10.1007/s40801-019-0150-8

Cited by 8 publications

(9 citation statements)

References 7 publications

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“…The identified data sources are shown as examples in Table 1 . Each data source has its strengths and limitations [ 27 – 31 ].…”

Section: Resultsmentioning

confidence: 99%

“…The MHLW, a ministry of the Japanese Health Government, implemented the MID-NET system and intended that it would become a major data source for PMS studies [ 6 , 38 ]. In addition, by comparing MDV dataset analysis with their prospective PMS study, Sakata et al demonstrated that large-scale database analysis with MDV Database could be useful in long-term drug safety assessment; these authors also mentioned that using a database decreased the time needed to complete a PMS study and was relatively inexpensive [ 31 ]. Data related to exposure to a new medicinal product is very limited in EHRs at the time when planning a PMS study but is collected and added to EHRs at medical institutions and then collated into large-scale integrated databases over time.…”

Section: Discussionmentioning

confidence: 99%

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Characterization and selection of Japanese electronic health record databases used as data sources for non-interventional observational studies

Wakabayashi

Eitoku

Suganuma

2021

BMC Med Inform Decis Mak

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Background Interventional studies are the fundamental method for obtaining answers to clinical questions. However, these studies are sometimes difficult to conduct because of insufficient financial or human resources or the rarity of the disease in question. One means of addressing these issues is to conduct a non-interventional observational study using electronic health record (EHR) databases as the data source, although how best to evaluate the suitability of an EHR database when planning a study remains to be clarified. The aim of the present study is to identify and characterize the data sources that have been used for conducting non-interventional observational studies in Japan and propose a flow diagram to help researchers determine the most appropriate EHR database for their study goals. Methods We compiled a list of published articles reporting observational studies conducted in Japan by searching PubMed for relevant articles published in the last 3 years and by searching database providers’ publication lists related to studies using their databases. For each article, we reviewed the abstract and/or full text to obtain information about data source, target disease or therapeutic area, number of patients, and study design (prospective or retrospective). We then characterized the identified EHR databases. Results In Japan, non-interventional observational studies have been mostly conducted using data stored locally at individual medical institutions (663/1511) or collected from several collaborating medical institutions (315/1511). Whereas the studies conducted with large-scale integrated databases (330/1511) were mostly retrospective (73.6%), 27.5% of the single-center studies, 47.6% of the multi-center studies, and 73.7% of the post-marketing surveillance studies, identified in the present study, were conducted prospectively. We used our findings to develop an assessment flow diagram to assist researchers in evaluating and choosing the most suitable EHR database for their study goals. Conclusions Our analysis revealed that the non-interventional observational studies were conducted using data stored local at individual medical institutions or collected from collaborating medical institutions in Japan. Disease registries, disease databases, and large-scale databases would enable researchers to conduct studies with large sample sizes to provide robust data from which strong inferences could be drawn.

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“…The identified data sources are shown as examples in Table 1 . Each data source has its strengths and limitations [ 27 – 31 ].…”

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Characterization and selection of Japanese electronic health record databases used as data sources for non-interventional observational studies

Wakabayashi

Eitoku

Suganuma

2021

BMC Med Inform Decis Mak

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“…It has been suggested that severe neutropenia could be more pronounced in east Asian populations, which is particularly reflected in the use of eribulin as a late-line treatment [ 28 ]. Indeed, an incidence rate of 57.4% for grade 4 neutropenia was observed in eribulin users in South Korea, and up to two-thirds of eribulin users had neutropenia in Japan [ 16 , 18 ].…”

Section: Discussionmentioning

confidence: 99%

“…Although another phase III trial, Study 301, failed to demonstrate the superiority of eribulin over capecitabine in terms of overall survival (OS) or progression-free survival (PFS) [ 8 ], a post hoc analysis reported a significant OS benefit for eribulin among MBC patients with human epidermal growth factor receptor 2 (HER2) negative tumors [ 9 ]. Since the U.S. Food and Drug Administration’s (FDA) approval of eribulin in November 2010, real-world evidence of eribulin has been investigated in various countries and among different ethnicities [ [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] ]. However, there has been a paucity of real-world studies that included comparative agents in their study design.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and healthcare costs of eribulin versus capecitabine among metastatic breast cancer patients in Taiwan

Yang

Kuo

2021

The Breast

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Objective To compare the real-world effectiveness and costs of eribulin to those of capecitabine in patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. Methods This study extracted data from the Health and Welfare Database in Taiwan to identify MBC patients, and then eribulin and capecitabine users were matched at a 1:1 ratio by age, residential region, Charlson Comorbidity Index score, and molecular subtype of BC cell. The overall survival (OS) and time-to-treatment discontinuation (TTD) curves were plotted using the Kaplan–Meier method. Healthcare utilization and costs between the two groups were compared. Results A total of 24,550 MBC patients were identified, and 298 patients were enrolled in each group after matching. The median OS was 11.8 months for eribulin (95%CI: 11.5–13.5 months) and 15.2 months for capecitabine (95%CI: 15.3–17.9 months; HR = 1.7, p < 0.0001). The median TTD was 4.0 months for eribulin and 6.6 months for capecitabine (HR = 1.6; p < 0.0001). No significant difference was found between the two groups in patients with >4 prior chemotherapy agents (OS: HR 1.1, 95%CI 0.8–1.5; TTD: HR 1.2, 95%CI 0.9–1.7). The total healthcare costs per patient during the treatment period were NT$580,523.8 for eribulin versus NT$497,223.8 for capecitabine (p < 0.0001), and total medication costs were NT$438,335.8 and NT$348,438.4 (p < 0.0001), respectively. Conclusion Although eribulin showed an attenuated effect in the real-world setting in Taiwan, it may serve as an alternative for capecitabine in a heavy pretreated population. The total healthcare and medication costs were found to be higher with eribulin treatment.

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“…Many research articles have utilized the MDV database to describe a wide range of outcomes, such as treatment patterns, prevalence, and adherence. [20][21][22][23][24][25][26][27][28][29][30] submit your manuscript | www.dovepress.com…”

Section: Study Design and Data Sourcementioning

confidence: 99%

Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database

Matsumoto¹,

Tsuchiya

Hirano³

et al. 2021

CEOR

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Purpose Infliximab, which was approved in 2002, had its first biosimilar launched in 2014 across Japan. However, the penetration rate of this biosimilar remains unclear given the limited data regarding its current clinical use throughout Japan. This study was conducted to describe the current clinical characteristics of patients receiving infliximab and the penetration rate of the reference infliximab and/or biosimilar infliximab using a Japanese administrative claims database. Patients and Methods This retrospective, descriptive study utilized the Japan Medical Data Vision database, a nationwide hospital-based database. Data on patients receiving infliximab recorded from April 2008 to March 2019 were extracted from the database. Patient characteristics of the reference and biosimilar infliximab groups and penetration rates according to fiscal year, target diseases diagnosis, and subsidy for intractable diseases were examined. Results A total of 9735 patients were extracted for analysis, among whom 92% (n=8950) and 8% (n=785) received only reference infliximab and its biosimilar, respectively. Both groups exhibited similar clinical characteristics. The biosimilar penetration rate increased from 0.8% in 2014 to 22.5% in 2018, with overall penetration rates throughout the period according to diagnosis (with or without subsidy) being 14.4% (with, 4.1%; without, 16.4%), 4.7% (with, 3.7%; without, 10.6%), 5.7% (with, 4.5%; without, 13.5%), and 7.5% (with, 4.4%; without, 8.2%) for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriasis, respectively. Conclusion Biosimilar infliximab is prescribed for patients with similar characteristics to reference infliximab. Despite the increasing penetration rates according to target disease, they remain much lower among patients receiving subsidy for intractable disease than among those who do not.

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Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study

Cited by 8 publications

References 7 publications

Characterization and selection of Japanese electronic health record databases used as data sources for non-interventional observational studies

Characterization and selection of Japanese electronic health record databases used as data sources for non-interventional observational studies

Effectiveness and healthcare costs of eribulin versus capecitabine among metastatic breast cancer patients in Taiwan

Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database

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