In April 2019, Japan formally introduced health technology assessment (HTA) and, more specifically, a cost-effectiveness analysis, to inform healthcare decision making, mainly when it comes to the pricing of new technologies. This article provides an overview of this new policy, which was implemented formally after a pilot program. In the fiscal year (FY) 2012, discussions on cost-effectiveness assessments were initiated in Japan. After 7 years of deliberations, a cost-effectiveness assessment was implemented formally in April 2019. In Japan, the cost-effectiveness analysis has been used to inform price adjustments of healthcare technologies, although it has not yet been used for decision making on insurance coverage. Selection criteria were established because not all drugs and medical devices could be evaluated owing to a shortage of experts. Exclusion criteria have also been applied to prevent access restriction. The scope of the evaluation's price adjustment target is limited to part of the product price. If the cost per quality-adjusted life-year (QALY) threshold falls below U5 million per QALY, the price adjustment rate changes stepwise according to the cost per QALY. In addition to price reduction, a priceraising scheme has also been implemented for scenarios where products are evaluated to be highly cost-effective and innovative. This article describes the first formally implemented HTA system in Japan. Although it is too early to make any conclusions about its effect, the Japan-specific context makes this system unique. To fully understand the opportunities and challenges of the new system, it is vital that Japan accumulates experience with this system and develops human resources in health economic evaluation.
BackgroundClient reminders are known to increase cancer screening attendance rates. However, there are significant costs associated with them, and their effect by population size is unknown.MethodsIn 2007 and 2008, the Japanese Government surveyed breast and cervical cancer screening in every municipality in Japan. From the results, we selected all 1,464 municipalities that carried out both screening types. We examined whether changes in screening attendance rates between 2007 and 2008 were associated with client reminders, number of public health nurses per 100,000 population, financial strength index, and 2007 attendance rates for different population sizes. We then calculated cost-effectiveness estimates of client reminders by population size and screening type.ResultsClient reminders were associated with increased attendance rates in populations <100,000. For populations of 50,000–100,000, there was a 2.76% increase in breast cancer screening (95% CI: 0.41, 5.11), and a 2.25% increase in cervical cancer screening (95% CI: 0.89, 3.61). The incremental cost per additional attendance was higher in populations <50,000 than in populations of 50,000–100,000 (breast, $100 versus $54; cervical, $149 versus $67 respectively).ConclusionsClient reminders for breast and cervical cancer screening increased attendance rates in smaller municipalities in Japan.
ObjectivesAdvances in health care due to the development and introduction of new drugs and medical devices have brought considerable benefits to people and patients in terms of upgraded quality of life and extended years of survival. However, some are concerned that the very advancement of health care would increase further the inflation of national healthcare costs. In response to these concerns, Japan's Central Social Insurance Medical Council (“Chuikyo”) began in 2012 to examine how cost-effectiveness evaluation might be applied to the national health insurance system, and has been working toward establishing a system for its usage.MethodsCost-effectiveness evaluation was adopted on a trial basis in fiscal year (FY) 2016, targeting seven drugs and six medical devices. Analyses and re-analyses were performed by manufacturers and a public expert organization, respectively. Based on these analyses, a cost-effectiveness evaluation expert organization conducted an overall assessment (“appraisal”). Results of the evaluation were used to adjust the prices of the target items.ResultsFollowing the trial adoption of cost-effectiveness evaluation, price adjustments were performed for three items in April 2018. Meanwhile, a decision was also made to examine seven items for which technical requirements were identified due to differences in the understanding of analysis methods between involved parties.ConclusionsThe Chuikyo will examine how to meet the newly identified technical requirements and discuss specific details with regard to establishing a system that incorporates cost-effectiveness evaluation. The Chuikyo plans to reach a conclusion by the end of FY 2018.
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