Health Technology Assessment in Japan: A Pharmaceutical Industry Perspective

Abstract

Although the government decided to implement HTA for the pricing scheme in 2018, a shortage of experts and researchers remains a challenge. Findings suggest HTA should not be used solely to reduce pharmaceutical spending, as the impact by the HTA implementation will be temporary and discourage innovation.

Health technology assessment in Japan: a work in progress

“…Across Sweden, Germany, France, the UK, and South Korea, for example, staffing of these authorities ranges from 125 to 2,121 individuals, with annual budgets ranging from 2.33 to 36.25 billion JPY, respectively 2 . Except for Chuikyo and C2H, Japan does not have a dedicated HTA authority, and there is concern among clinicians and industry that there is a need to strengthen HTA expertise among MHLW personnel 9,24 . A further potential concern is that lack of capacity to undertake HTAs could introduce delays to patient access to new treatment options in the future 24 .…”

“…Except for Chuikyo and C2H, Japan does not have a dedicated HTA authority, and there is concern among clinicians and industry that there is a need to strengthen HTA expertise among MHLW personnel 9,24 . A further potential concern is that lack of capacity to undertake HTAs could introduce delays to patient access to new treatment options in the future 24 . A recent analysis of 569 oncology HTAs for drugs approved in Canada, Australia, France, Germany, and the UK showed that it takes a median of 214 days from regulatory approval to a reimbursement decision 25 .…”

“…As such, there is a need to develop HTA expertise and infrastructure in the country, notably within academia, clinician settings, and industry. A survey of 21 pharmaceutical companies (including 14 domestic Japanese companies) conducted from December 2016 to March 2017 showed that although most global companies (a company that originated out of Japan but has a registered subsidiary in Japan) have dedicated HTA teams in their Japan office, few domestic Japanese companies have established HTA resources 24 . At most, domestic Japanese companies have HTA teams that are convened on an as-needed basis, and most staff who conduct HTA research are not fully qualified in disciplines such as health economics, statistics, or public health.…”

“…At most, domestic Japanese companies have HTA teams that are convened on an as-needed basis, and most staff who conduct HTA research are not fully qualified in disciplines such as health economics, statistics, or public health. In addition, the survey revealed that there is a shortage of academic experts and consultants in Japan with the expertise to conduct HTA research and analyses: this has implications for the availability of experts to conduct HTA reviews for MHLW 24 . According to the timeline for the HTA process proposed by Chuikyo in 2019, a maximum of 9 months is set for companies to conduct the analyses (including 3-6 months for prior consultation with C2H), 3 months is set for independent HTA review, and 3 months for evaluation and price determination.…”

“…In Japan, there is an abundance of clinical trial data focusing on efficacy and safety, but relatively fewer clinical trials incorporate patient-reported outcomes or quality-of-life measures that can be used to inform cost-effectiveness analyses. Of the 21 company respondents to the survey on HTA in Japan, 8 planned to collect quality-of-life data from global clinical trials and the literature, 8 planned to collect the data from local clinical trials and surveys and had established relationships with external consultants, and 5 had no plans for how quality-of-life data were to be collected 24 , suggesting that generation of quality-of-life data in Japan is still at an early stage.…”