German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

Dilip Patel, Nneka Onwudiwe, Angela Borghouts-de Ruijter, Paolo Morgese and Matias Olsen at the Advanced Therapies Congress in London, 2025 (Norstella)

Real-world data (RWD) and real-world evidence (RWE) have the potential to help support companies in demonstrating the value of novel therapies to payers in Europe, particularly in the gene therapy space where trial evidence might be more limited than usual. But according to company executives speaking at the Advanced Therapies Congress held in London, UK, this week, many health technology assessment (HTA) bodies are either unable or unwilling to use this type of data.

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