Japan will implement a new HTA process from April 2019, following a successful pilot project begun in April 2016. However concerns have been raised regarding the extent to which this complies with industry good practice as set out by ISPOR’s HTA Taskforce.
The new HTA process will include medical drugs and devices, and will exclude products used solely for rare diseases (where there are no current treatments), or used solely for paediatric diseases. The standard assessment route will use a QALY threshold of JPY5million, after which price premiums will be progressively reduced (by up to 90%) until the threshold of JPY10million. The special assessment route, for products with rare disease, paediatric or anti-cancer indications, will use QALY thresholds that are 50% higher. There is industry concern that these thresholds could significantly cut profit margins.
There is also concern that Japan’s HTA process does not meet ISPOR’s ‘governance, framing and scoping’ requirements, as current guidelines are not sufficiently clear regarding:
- Pre-assessment meetings
- How to submit evidence
- How the evidence will be analysed
- How the evidence will be shared with companies in order to resolve issues quickly
An additional worry with this version of Japan’s HTA process is that it does not meet ISPOR’s ‘contextualisation’ requirements; there is no patient engagement and analyses appear to centre around ICER results.
Despite the concerns he raises, Adrian Towse highlights the potential opportunities inherent in this approach:
‘It provides . . . an opportunity to explore whether forms of structured decision making, based on MCDA, can systematically capture non-QALY attributes and relevant social values and combine them within a QALY-based system. It could lead the world in doing this.’
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