Presentation (CTI)

OBJECTIVES: Access to medicines in European countries is currently unequal, with some HTA agencies receiving earlier submissions than others. The HTA Regulation, implemented for oncology products in January 2025, strives to improve timely access to medicines across Europe. This study aims to baseline the submission trend to oncology medicines in Europe prior to JCA implementation.
METHODS: The regulatory approval dates were extracted from EMA reports from oncology NASs approved between 01-Jan-2018 to 31-Dec-2023. The HTA submission dates were extracted or requested for France, Germany, Ireland, Netherlands, Poland and Sweden. The submission gap is defined as EMA approval date to HTA submission date, median time and variability with 25^th and 75^th percentiles were calculated.
RESULTS: The EMA approved 231 NASs between 2018 and 2023, 72 were oncology NASs (31%). Three countries showed a submission gap of less than 2 months, France, Germany and Ireland, with 33, 40 and 60 days respectively. While the remaining 3 countries’ median submission gaps exceeded 5 months. The variability of the submission gap was also analysed, and France and Germany presented narrower ranges (29 to 69 days, 26 to 138 days, respectively) compared to the rest. Wider ranges were observed in the other 4 countries such as Netherlands, showing the widest range from 116 to 535 days. Factors that may affect submission strategy such as company size, conditional and accelerated EMA approvals were also explored.
CONCLUSIONS: Our analysis demonstrated that a high proportion of EMA approvals between 2018 and 2023 were oncology products. The submission gap and variation of this gap is considerably different between countries, with France and Germany demonstrating quicker time to submission. These results will provide a useful baseline to compare if the regulation leads to an improvement in submission gaps across Europe.