As the EU HTAR moved from policy text to operational reality there are immediate implications for pharmaceutical and biotech companies, starting with the expansion of Europe’s Joint Clinical Assessment (JCA).
The EU HTAR is now applicable for the first wave of products—oncology medicines and advanced therapy medicinal products (ATMPs)—leading to structural changes to the way clinical evidence is planned, generated, synthesised, and presented for European market access. This requires new, mandatory pan-European evidence to run in parallel with European Medicines Agency (EMA) regulatory timelines which, in turn, demands a level of anticipatory readiness that most organisations haven’t yet built.
Our latest whitepaper discusses the challenges of ensuring EU HTAR readiness, including the role of AI as decision-making infrastructure, how to prepare evidence for multiple population, intervention, comparator, and outcome (PICO) scenarios, and the structural limits of traditional, manual approaches.
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