title: Obtaining reimbursement in France and Italy for new diabetes products.
abstract: Manufacturers launching next-generation or innovative medical devices in Europe face a very heterogeneous reimbursement landscape, with each country having its own pathways, timing, requirements and success factors. We selected 2 markets for a deeper look into the reimbursement landscape: France, representing a country with central decision making with defined processes, and Italy, which delegates reimbursement decisions to the regional level, resulting in a less transparent approach to reimbursement. Based on our experience in working on various new product launches and analyzing recent reimbursement decisions, we found that payers in both countries do not reward improved next-generation products with incremental reimbursement. Looking at innovations, we observe that manufacturers face a challenging and lengthy process to obtain reimbursement. In addition, requirements and key success factors differ by country: In France, comparative clinical evidence and budget impact very much drive reimbursement decisions in terms of pricing and restrictions, whereas in Italy, regional key opinion leader (KOL) support and additional local observational data are key.
authors.affiliation: InsuLine Medical GmbH, Mannheim, Germany.
authors.forename: Elmar
authors.initials: E
authors.lastname: Schaefer
authors.affiliation: Simon-Kucher & Partners, Cologne, Germany Gerald.Schnell@simon-kucher.com.
authors.forename: Gerald
authors.initials: G
authors.lastname: Schnell
authors.affiliation: Simon-Kucher & Partners, Cologne, Germany.
authors.forename: Jessica
authors.initials: J
authors.lastname: Sonsalla
mesh_terms: D015190:Blood Glucose Self-Monitoring / Q000191:economics / Q000295:instrumentation; D003365:Costs and Cost Analysis; D003657:Decision Making; D003920:Diabetes Mellitus / Q000097:blood / Q000191:economics* / Q000628:therapy*; D004864:Equipment and Supplies / Q000191:economics*; D005602:France; D006801:Humans; D007332:Insulin Infusion Systems / Q000191:economics; D007558:Italy; D012051:Reimbursement Mechanisms / Q000458:organization & administration / Q000639:trends; D017216:Telemedicine / Q000191:economics / Q000295:instrumentation; D035703:Therapies, Investigational / Q000191:economics / Q000295:instrumentation*
keywords: France; Italy; clinical evidence; market access; medical devices; price; reimbursement; reimbursement requirements; reimbursement system