Japan’s healthcare ecosystem is evolving rapidly, and understanding the dynamics of drug pricing and Health Technology Assessments (HTA) is key to grasping the future of healthcare in the Land of the Rising Sun.
Let’s delve into the current scenario:
- Escalating healthcare costs: Japan is witnessing a surge in healthcare expenditure, primarily driven by its aging population and the advent of groundbreaking regenerative medicines like gene therapy. In this era of budget constraints, HTA emerges as an additional critical tool to justify the cost of drugs.
- HTA’s emergence: Formal introduction of HTA in April 2019 was a response to the mounting economic pressure on the healthcare system. Unlike many other countries who use HTA to determine formulary access, HTA in Japan takes place after initial drug pricing, evaluating whether the premium received is warranted.
- Rigorous HTA process: The HTA process adheres to a strict timeline, with HTA dossiers submitted within 9 months after targeting a product. Detailed methodological guidelines, crafted by Japan’s official HTA organization (C2H), govern this process.
- Selective evaluation by HTA: Not all new technologies undergo HTA evaluation. Chuikyo, the Central Social Insurance Medical Council, selects products for HTA based on innovation, market size, and exceptionally high drug prices. Once selected, all products follow the same HTA route.
- Changing paradigm: Although HTA’s direct impact on drug prices is currently limited, it marks a shift from fee-for-service to pay-for-performance in healthcare policy. Justifying drug prices while considering outcomes and economic aspects becomes increasingly vital.
Preparation is key
Early preparations related to HTA elements prove advantageous, not only for HTA submissions but also for demonstrating added value. This includes identifying unmet medical needs, quantifying patient burden through patient reported outcomes (PRO), assessing indirect costs such as caregiver burden from a societal perspective, and gathering parameter information through literature reviews, real-world data (RWD), and surveys. Additionally, preparing early cost-effectiveness analysis (CEA) models in Japan is crucial to support evidence planning needs, discussions on innovation status of new technologies, and validating the model before HTA submission.
Comparing HTA guidelines: Japan vs. Europe
In the realm of Health Technology Assessments (HTA), understanding regional differences is crucial. We have compared Japanese HTA guidelines to current HTA guidelines in six countries and identified similarities and differences between Japanese and other major HTA guidelines and the outcome will be presented at the upcoming ISPOR meeting in Copenhagen.
Currently, there’s an ongoing discussion at Chuikyo regarding Lecanemab, and pricing decisions are imminent. What’s noteworthy is the inclusion of Health Economics and Outcomes Research (HEOR), focusing on aspects like caregiver burden and CEA, which is somewhat unconventional in drug pricing discussions but may herald a new trend.
Let’s keep a close watch on these developments as they reflect Japan’s commitment to balancing innovation, healthcare sustainability, and patient well-being. As the healthcare landscape continues to evolve, collaboration and adaptability will be key to ensuring optimal patient care.
Learn more on the English Methodological Guidelines for HTA here.