Presentation (CTI)

OBJECTIVES: Following European regulatory approval, pharmaceutical companies must navigate diverse national health technology assessment (HTA) and pricing systems, alongside strategic launch sequencing decisions. This leads to variation in patient access timelines, translating into inequities whereby patients in different countries experience different delays in accessing the same therapies. This study assessed cross-country variation in time to market access and characterised patterns across countries to quantify the extent of these inequities.
METHODS: A retrospective analysis was conducted using product-level data from the GlobalData POLI (price intelligence) database. Branded medicines receiving European Medicines Agency (EMA) approval between 2020 and 2025 were included. Time to market access was defined as the number of days from EMA approval to the first recorded national pricing milestone. Countries included were Belgium, France, Germany, Italy, the Netherlands, Poland, Portugal, Spain, Sweden, and the UK. Median time to pricing was compared across countries using distributional statistics.
RESULTS: Substantial variation in “time to pricing” was observed across countries. Median time to pricing was lowest in the UK (163 days) and France (287 days), followed by Portugal (340 days), Italy (415 days), Spain (548 days), Germany (568 days), Sweden (545 days), and Belgium (551 days). The longest timelines were observed in Poland (787 days) and the Netherlands (999 days), representing a more than six-fold difference between the fastest and slowest markets.
CONCLUSIONS: Variation in access timelines persists across European markets, translating into substantial inequities in the timing of patient access to therapies. While initiatives such as Joint Clinical Assessments (JCAs) aim to harmonise elements of HTA, their impact on timelines remains uncertain. Countries with shorter timelines, such as the UK, may continue to diverge from EU markets, although structured JCA timelines could reduce variability depending on subsequent national decision-making. Overall, unequal delays are likely to persist, with implications for equity and patient outcomes across Europe.