This R&D Briefing presents findings from HTADock, an ongoing CIRS metrics study that collects publicly available data on new active substances (NASs) appraised by 12 HTA agencies in Australia (PBAC), Canada (CDA-AMC and INESSS), England (NICE), France (HAS), Germany (IQWiG), Ireland (NCPE), the Netherlands (ZIN), Poland (AOTMiT), Portugal (INFARMED), Scotland (SMC) and Sweden (TLV).
The briefing examines the synchronisation of regulatory and HTA processes, key product characteristics, and includes focus sections on Project Orbis and the Access Consortium. Country-specific analyses for Australia, Canada, the UK, Ireland, France, and Europe (including PRIME products) are also presented.
Key insights from the briefing include:
- HTA Outcomes: Germany issued the highest number of first HTA recommendations in 2024, while Australia saw a notable rise in positive first HTA recommendations in 2024 compared to 2020-2023.
- HTA Timelines: Canada presented the shortest median rollout time from regulatory submission to first HTA recommendation in 2024, while Germany had the fastest HTA review time.
- Expedited Regulatory Review: In all jurisdictions, except for the Netherlands and Sweden, the median overall time from regulatory submission to HTA recommendation was shorter for products undergoing an expedited review compared to those following the standard review process.
- Parallel Submissions: Parallel regulatory/HTA submissions in Australia and Canada led to faster median rollout times compared to products submitted sequentially.
- Common Products: Eight NASs received HTA recommendations in all 12 studied countries, but outcomes and timing differed, suggesting disparities in patient access.
If you have any questions or comments on this briefing, please get in touch with Dr Tina Wang: twang@cirsci.org
