Comparative evidence for EU HTA

The implementation of the new European Health Technology Assessment (EU HTA) process represents a fundamental turning point for health technology developers (HTDs), HTA bodies, payers and patients. Joint Clinical Assessments (JCAs) aim to streamline HTA efforts across EU Member States and ultimately accelerate patient access to innovative medicines. Since clinical guidelines, care pathways and standard of care treatments vary across EU Member States, HTDs will need to submit extensive comparative evidence to cover all relevant Populations, Interventions, Comparators and Outcomes (PICOs). As such, the new EU HTA process entails a paradigm shift from single indirect treatment comparisons (ITCs) to large ITC programs which cover all comparative evidence requirements in a comprehensive, well-planned, analytically robust and rapidly updatable way, and can also serve ITC requirements beyond the EU.

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Regulatory and Reimbursement Success with External Comparators

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