OP248 A Minimum Data-Set For Left Ventricular Assist Device On Destination Therapy: Cross-Border Collaboration Pilot On Real World Data

Introduction The European Health Technology Assessment Network (EUnetHTA) Work Package 5B1, is focused on testing the levels of cross-border collaboration real world data for supporting reimbursement/pricing decision-making. Within this Package, we are conducting a pilot Left Ventricular Assist Device destination therapy in with National Institute and Care Excellence (NICE, UK), Belgian Knowledge Centre (KCE, Belgium) Italian Agency Regional Services (AGENAS, Italy). This aims to define minimum set gathering sharing high quality registry key uncertainties found at time health technology assessment (HTA). Furthermore, will assess feasibility carrying out common analysis or reusing Joint Reassessments. Methods Evidence gaps were based four national assessments. Collaborating partners responsible agreeing outcomes proposing dataset be registered. clinical experts patients rated prioritized using two round Delphi technique (not relevant, important but not critical; critical). confirm basis Spanish LVAD registry, implemented service level inform inclusion into healthcare portfolio. Results agreed upon by agencies relate safety, effectiveness, satisfaction acceptability patient cost-effectiveness, budget impact organizational impact. Expert cardiologists cardiac surgeons representing Society, among others, participated prioritization basic data. final expected December 2020. Conclusions variation definition outcome measures measuring evidence reduces utility registries HTA, making it difficult compare, link, aggregate across countries. EUnetHTA intended offer model decision-making process pricing reimbursement.