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Impact of health insurance coverage for Helicobacter pylori gastritis on the trends in eradication therapy in Japan: retrospective observational study and simulation study based on real-world data
  1. Shinzo Hiroi1,2,
  2. Kentaro Sugano3,
  3. Shiro Tanaka4,
  4. Koji Kawakami1
  1. 1 Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan
  2. 2 Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan
  3. 3 Department of Medicine, Jichi Medical University, Tochigi, Japan
  4. 4 Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan
  1. Correspondence to Dr Koji Kawakami; kawakami.koji.4e{at}


Objectives To explore the prevalence of Helicobacter pylori infection in Japan and the trends of its eradication therapy before and after the changes of the insurance coverage policy, first started in 2000, and expanded to cover H. pylori-positive gastritis in 2013. The impacts that the changes brought were estimated.

Methods In this retrospective observational study and simulation study based on health insurance claims data, product sales data and relevant studies, individuals who received triple therapy (amoxicillin, clarithromycin, proton-pump inhibitors or potassium-competitive acid blockers) were defined as the first-time patients for H. pylori eradication in two Japanese health insurance claims databases (from approximately 1.6 million and 10.5 million individuals). Each sales data of eradication packages and examination kits were used to estimate the number of H. pylori-eradicated individuals nationwide. The prevalence of H. pylori infection, including the future rate, was predicted using previous studies and the estimated population trend by a national institute. Cases completed prior to the policy change on insurance coverage were simulated to estimate what would have happened had there been no change in the policy.

Results The numbers of patients first received eradication therapy were 81 119 and 170 993 from two databases. The nationwide estimated number of patients successfully eradicated was approximately 650 000 per year between 2001 and 2012, whereas it rapidly rose to 1 380-000 per year in 2013. The estimated prevalence of infection in 2050 is 5%, this rate was estimated to be 28% and 22% if the policy changes had not occurred in 2000 and 2013, respectively.

Conclusions The impact of policy changes for H. pylori eradication therapy on the prevalence of infection was shown. The results suggest that insurance coverage expansion may also reduce the prevalence in other countries with a high prevalence of H. pylori infection if the reinfection is low.

  • health insurance
  • helicobacter pylor
  • helicobacter pylori eradication
  • helicobacter pylori-positive gastritis

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  • Contributors SH, KS and KK contributed to the concept and design of the study. SH contributed to acquisition of data. SH contributed to the analysis. SH, KS and ST contributed to interpretation of data. SH, KS, ST and KK contributed to the writing of the manuscript and critical revision of the manuscript. All authors approved the final version of the manuscript. KK is the guarantor of the article.

  • Funding This study was sponsored by Takeda Pharmaceutical.

  • Competing interests SH is an employee of Takeda Pharmaceutical. KS received research grants from Eisai, Daiichi Sankyo Pharma and Takeda Pharmaceutical. He also received lecture fees from Astellas Pharma, Fujifilm and Takeda Pharmaceutical. ST has no personal interests to declare. KK received research funds from Dainippon Sumitomo Pharma, Olympus, Stella Pharma, Medical Platform, Novartis Pharmaceutical, Bayer and Maruho; honorarium from Astellas, Daiichi Sankyo Pharma, Taisho Pharmaceutical, Eisai, Novartis Pharmaceutical, Mitsubishi Tanabe Pharma, Takeda Pharmaceutical and Sanofi; consulting fees from Olympus, Kyowa Hakko Kirin, Kaken Pharmaceutical and Otsuka Pharmaceutical. There are no patents, products in development or marketed products to declare, relevant to those companies.

  • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

  • Ethics approval This study was approved by Ethic Committee, Kyoto University Graduate School and Faculty of Medicine (R0126-1). This study was exempted from obtaining individual informed consent based on Ethical Guidelines for Medical and Health Research Involving Human Subjects by Ministry of Education, Culture, Sports, Science and Technology, and Ministry of Health, Labour and Welfare.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.

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