Diabetes Device Reimbursement in the EU - 5 Schäfer

The reimbursement landscape for new and innovative diabetes devices in Europe is very heterogeneous and nontransparent, with each country employing different mechanisms, pathways, and requirements. This article provides an overview of how diabetes device reimbursement works in the outpatient setting in the five major European Union markets (France, Germany, Italy, Spain, and the United Kingdom; the EU-5). It will be of particular interest to manufacturers of innovative devices. Markets are first categorized as either a centralized or a regionalized reimbursement decision-making system, and implications for device reimbursement are explored. In the second part, specific requirements and success factors for wide reimbursement in the EU-5 are analyzed in detail. Gaining early acceptance by the main influencers (key opinion leaders and payers) is the first step. Equally important is the provision of convincing evidence, be this clinical, health–economic (cost-effectiveness), or a demonstration of cost savings (budget impact). In some countries, local usage data may be a requirement as well. Lastly, as payers’ willingness to pay stems directly from their perceived value of a device, a key success factor and a necessary precondition for manufacturers is to set the right price. J Diabetes Sci Technol 2013;7(4):1084–1092 REIMBURSEMENT for Diabetes Society Introduction The reimbursement landscape for new and innovative diabetes devices in Europe is heterogeneous, not very transparent, and in constant flux. Any company that seeks to obtain reimbursement for a new device will soon discover that each country has its own mechanisms and pathways, and despite the laws and official reimbursement guidelines, requirements are often vague and success factors far from obvious. This article aims to clear the confusion and provide an overview of how diabetes device reimbursement works in the EU-5: France, Germany, Italy, Spain, and the United Kingdom. We will focus on reimbursement in the outpatient setting because most diabetes devices, such as blood glucose monitoring devices, insulin pumps, and insulin needles, are designed for patients to use at home. To do this, we first categorize the markets according to their reimbursement systems—either with central or regional reimbursement decision making—and explore the implications when applying for device reimbursement. In the second