The European health technology assessment (HTA) landscape has undergone a fundamental transformation with the implementation of the European Regulation on Health Technology Assessment (EU 2021/2282) and the introduction of Joint Clinical Assessments (JCAs).
Our whitepaper looks at what it actually takes to build a defensible evidence package, from comparative evidence without randomization, to preserving scarce patient data in RWE analyses, to demonstrating that evidence generated in one country holds up across the whole EU.
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