Is a HTA process introduced in pharma/device pricing in Japan?
Currently 13 products are taken as trial cases. In March 7th, a brief... very brief summary of CEA results and suggestions from a temporal appraisal committee were published and further discussed in the expert committee in Chuikyo, Central Social Insurance Medical Council. [meeting materials are only available in Japanese at; www.mhlw.go.jp/stf/shingi2/0000196685.html]
Within 13 products, 2 products are decided to reduce their price at re-pricing, effective from 2018 April, Opdivor(r) and Kadcyla(r), while positive re-pricing on one product, Najuta(r). The decision was made based on the threshold of five million JPY/QALY* and 'ethical/social factors'* through the appraisal process.
*Note; both the threshold and the 'ethical/social factors' are the tentative rules specifically decided for the trial use only. They will be further discussed toward the end of 2018.
I have observed two main discussion points at the March 7th meeting; 1) CEA concept/scientific advice, and 2) Willingness to Pay.
1) CEA concept or structure development was confirmed not enough and a lack of agreement on the concept between manufacturers and the committee prior to start the actual analysis resulted discrepancy in their CEA outcomes. At the appraisal process, the decision was made based on the better outcome among the two analysis results. For the future practice, MHLW suggested a working group under Chukyo by inviting medical expert, prior to start analysis to agree on CEA concept. The suggestion was not quite accepted by some committee members, because the more closed committees means the less transparency to public and to the final decision makers.
2) Willingness to pay research has been suggested to determine the threshold, but the idea of 'price on life' has been facing persistent resistance with the ethical point of view. Having said that, some committee members noted the importance and high priority of deciding legitimate threshold to introduce CEA in pricing/re-pricing, by the end of 2018.
Despite the schedule presented to introduce new HTA system by the end of 2018, it might take more than two years to start up a partial HTA system (e.g. only for re-pricing for some products) and possibly five years to set up a complete HTA system in pricing/re-pricing in Japan. Having said that, at a raising awareness, CEA could be well accepted as a communication tool to present the value of a product to various stakeholders, from market access point of view.