This R&D Briefing presents data from HTADock, an ongoing CIRS benchmarking study that collects publicly available data on new active substances (NASs) appraised by key international HTA agencies.

This CIRS R&D Briefing reviews EMA oncology approvals from 2018 to 2023 and their first HTA outcomes and timelines across seven key EU jurisdictions. The agencies involved in this study are:

  1. French Haute Autorité de Santé (HAS)
  2. German Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)
  3. Irish National Centre for Pharmacoeconomics (NCPE)
  4. Zorginstituut Nederland (ZIN)
  5. Polish Agencja Oceny Technologii Medycznych i Taryfikacji (AOTMiT)
  6. Portuguese Autoridade Nacional do Medicamento e Produtos de Saude (INFARMED)
  7. Swedish Tandvårds & läkemedelsförmånsverket (TLV).

The insights derived from this research form an essential component of CIRS’s ongoing commitment to advancing regulatory and HTA policies and processes. They act as an important baseline for measuring the impact of Joint Clinical Assessment (JCA) under the EU HTA Regulation, which is now in play for oncology products and ATMPs, and will gradually be rolled out to cover all centrally authorised products by 2030.

If you have any questions or comments on this briefing, please get in touch with Dr Tina Wang: twang@cirsci.org