The latest HTADock R&D Briefing examines HTA outcomes and timelines for new active substances reviewed between 2021 and 2025 by 12 HTA agencies across Australia, Canada, Europe, and the UK. Drawing on publicly available data, the analysis explores how regulatory-HTA synchronisation, submission strategies, regulatory pathways, and national review processes influence the timing and outcomes of HTA assessments. The study provides insights into differences in access pathways across jurisdictions and highlights trends that may be relevant to HTA agencies and pharmaceutical companies.
Key findings
- Australia recorded the shortest median rollout time from regulatory submission to first HTA recommendation in 2025, followed by CDA-AMC (Canada), while Germany demonstrated the greatest consistency in rollout times between 2021 and 2025.
- HTA submission strategies varied considerably across jurisdictions. Australia, Canada, England, France, and Germany received the majority of submissions within three months of regulatory approval, whereas longer delays were observed in countries such as the Netherlands and Poland.
- Products reviewed through expedited regulatory pathways generally achieved shorter overall rollout times than those reviewed through standard pathways, highlighting the potential impact of accelerated regulatory processes on access timelines.
- Ten new active substances received first HTA recommendations in all 12 jurisdictions. Differences in outcomes and timing across countries suggest potential variation in patient access to innovative medicines.
- Anti-cancer and immunomodulatory medicines represented the largest therapeutic area assessed, accounting for 64% of products within the four most common therapeutic categories reviewed by HTA agencies.
Why this research matters
As HTA continues to play an increasingly important role in reimbursement and patient access decisions, understanding differences in HTA outcomes and timelines across jurisdictions is becoming increasingly valuable. This briefing provides a comparative analysis of 12 international HTA agencies, offering insights into review timelines, regulatory-HTA alignment, and the factors that contribute to variations in market access pathways.
The findings support ongoing discussions on efficiency, transparency, and predictability within HTA systems and contribute to the broader objectives of the CIRS HTA research programme.
