Japan plans to introduce Health Technology Assessment (HTA) in 2018 after a two-year trial period. Japan currently requires HTA for certain innovative products which may have a large budget impact. Through this trial implementation, the government can examine the criteria of applicable products, the necessary infrastructure to conduct and evaluate HTA, the quality of data content, and localization to meet the current Japanese reimbursement and pricing scheme. However, the pharmaceutical industry in Japan is still puzzled by this introduction. The aim of this study is to visualize the issues and implementation challenges of HTA in Japan through a survey of the pharmaceutical industry.

A semi-structured nineteen-item questionnaire was designed and the survey was conducted through face-to face or phone interviews. Answers were summarized after the interview and confirmed with the respondents via e-mail. The survey focused on pharmaceutical companies which develop new innovative products.

The differences between Japanese and non-Japanese pharmaceutical companies were observed in terms of HTA staff expertise and experience, the source of HTA data, and relationships with external vendors. Many respondents stated that a sufficient number of HTA professionals in Japan is critical to implement HTA, and raised a concern that the same public experts who are involved in HTA preparation may also review HTA submissions. Although companies are generally pessimistic about HTA for pharmaceutical pricing, they also have some positive views that HTA may be used as an indicator to enable stakeholders to understand product value. Many are unsure about the link between HTA and pharmaceutical prices.

If HTA is implemented for an extended number of products, a shortage of experts may cause delays of HTA review and appraisal processes. Consequently, product launch and patient access will be delayed. Practical timing of HTA review and appraisal after product launch could affect the results of re-pricing.