Presentation (CTI)

OBJECTIVES: Key challenges in evidence generation for Medical Technology (MedTech) include collection of long-term real-world evidence (RWE), country-specific and economic data. This can undermine payer confidence in pricing and reimbursement (P&R) decision-making. To address this, various early access schemes (EAS) across Europe provisionally fund novel MedTech to enable structured generation of RWE to inform P&R decision-making. Here, we assess existing EASs for MedTech across Europe, providing a summary of key findings, with a specific focus on England and Wales. The aim is to offer targeted recommendations on how to leverage the National Institute for Health and Care Excellence (NICE) EAS to support evidence generation and facilitate more streamlined reimbursement pathways.
METHODS: Desk research was conducted to map the availability and requirements of EASs across Europe. Further UK-specific insights were obtained through attendance at NICE masterclasses and from NICE experts. These, combined with our MedTech experience, informed our NICE-focused recommendations for developers.
RESULTS: Of the EASs that exist across Europe, Germany (DiGA, NUB), France (PECAN, Forfait Innovation), and the England and Wales (NICE early-value assessment [EVA] program) have the most established and influential schemes. These frameworks all support evidence generation and early engagement with payers, making them highly relevant for MedTech developers.Leveraging our UK MedTech experience, we outline how developers can effectively engage with the NICE pathway. To maximise selection chances, developers should register with NICE’s Innovation Service early and engage clinicians who can nominate technologies. They must also define their technology’s role in the NHS care pathway, demonstrate cost savings or efficiencies, and develop clear value propositions to support dialogue with decision-makers.
CONCLUSIONS: EASs offer a strategic route to reduce time-to-reimbursement while addressing evidence gaps. Success with NICE depends on early engagement, aligning evidence plans with NHS needs, and clearly demonstrating system value.