Module 1 2021

28/06/2021

HTA

Japan will introduce a new HTA based on cost effectiveness

Trials to roll out new HTA are being assessed

Greater Emphasis on Cost-effectiveness

Not clear how new HTA will be included in NHI price calculation

Watch the space!

Distribution to third parties is not allowed

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Sakigake Designation

Criteria : - Medical products for diseases in urgent need of innovative that will be developed and filed (NDA) first in Japan - Prominent effectiveness (i.e. radical improvement compared to existing therapy) is expected based

Benefits :

- Priority consultation - Substantial pre-application consultation - Priority review - PMDA Project manager

Distribution to third parties is not allowed

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21