5. Application of Japanese Claims Database to Pharmacovigilance Activity in Pharmaceutical Industry; Analysis on Cancer Incidences and Usage of Anticancer Agents

Abstract

EGFR inhibitor-associated rash：future directions for management and investigation outcomes from ／ the HER1／EGFR inhibitor rash management forum. Application of a Japanese insurance claims database to pharmacovigilance activities in pharmaceutical industry was discussed. Using a commercially available insurance claims database, incidences of several cancers, the number of patients who were administered anticancer agents, and possible adverse effects were studied. Cancer incidences obtained from the database were virtually equivalent to those from a traditional survey program. The number of cancer patients included in the database with one million beneficiaries, were a few thousands a year. Disorders in epithelial-derived tissue were observed more frequently in lung cancer patients after the initiation of EGF tyrosine kinase inhibitor therapy than after platinum-based therapy, suggesting possible candidates of adverse effects of the EGF tyrosine kinase. We concluded that an estimation of disease incidence and selecting candidates of adverse events with the claims database is theoretically possible. And the database is also applicable to pharmacovigilance fields. （Jpn J Pharmacoepidemiol 2012；17(2） ：145-153)

Prevalence, incidence, and medications of narcolepsy in Japan: a descriptive observational study using a health insurance claims database

“…The size of the corporations and occupations/industries were however unknown because this information was not disclosed by the data provider for the protection of personal information. Not many people aged 65 years or older were included in the database, and people aged 75 years or older were not included; however, children and adolescents, who may develop narcolepsy, are included [ 20 ], enabling us to examine pediatric narcolepsy in a large study population. Second, diagnosis records of narcolepsy extracted from the health insurance claims database were entered for billing purposes and, as aforementioned, may not reflect actual diagnoses, which may have influenced estimates of prevalence and incidence and medication use.…”

“…As the JMDC database includes records of the insured dependents, young individuals in whom narcolepsy onset is typically found (< 30 years old) [ 2 , 3 ], are included in the database. Additionally, the proportions of teens and young adults aged < 30 years old included in the JMDC database population are higher than those in the general population [ 20 ]. Long-term treatment patterns can also be examined with these data because individual medical and treatment history from multiple medical services can be traced, unless an insured employee withdraws from the employment-based health insurance program.…”

Inventory of real‐world data sources in Japan: Annual survey conducted by the Japanese Society for Pharmacoepidemiology Task Force

“…A full list of responses is available on the website of the Japanese Society for Pharmacoepidemiology (https://www.jspe.jp/committee/020/0210/). We received information for eight hospital databases: the National Hospital Organization Clinical Data Archives (NCDA), 10 4DIN Research Network, the Real‐World Data (RWD) database, Life Data Initiative (LDI), 11 Medical Information Database Network (MID‐NET), 12 Medical Data Vision (MDV), 13 JMDC (the former name was Japan Medical Data Center) hospital‐based database, and the National Clinical Database (NCD) 14,15 ; six insurer‐based databases: the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), 16 the JMDC payer‐based database, 17 Cross Fact, JammNet, MDV, and DeSC Healthcare (DeSC) database 18 ; four pharmacy‐based databases: Cross Fact, IQVIA National Prescription Audit (NPA) database, the Nihon Chouzai Pharmacy Claims database, and PFR; and two “other” databases: the National Health and Wellness Survey and PatientsMap.…”

Do Age-related Differences in the Incidence of Mumps Deafness Reflect a True Difference or a Misclassification of Mumps Deafness?

“…3 The Japanese Medical Data Center (JMDC) database is based on employment-based health insurance claims, and it mainly covers the population younger than 65 years. 4 The database contained 5.5 million subjects as of June 2018, 1 and accounted for about 6.1% of the total population of Japan younger than 65 years. 5 Based on a sentinel surveillance rate of 6%, there should be 26,860 to 81,360 cases of pediatric mumps annually.…”