Schäfer Elmar, Schnell Gerald, Bobáková Tamara
InsuLine Medical GmbH, Mannheim, Germany.
J Diabetes Sci Technol. 2013 Jul 1;7(4):1084-92. doi: 10.1177/193229681300700433.
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.
欧洲新型和创新型糖尿病设备的报销情况非常复杂且不透明，每个国家都采用不同的机制、途径和要求。本文概述了在欧盟五个主要市场（法国、德国、意大利、西班牙和英国；欧盟五国）的门诊环境中糖尿病设备报销的运作方式。这对于创新设备制造商来说将特别有兴趣。首先将市场分为集中式或区域化报销决策系统，并探讨其对设备报销的影响。在第二部分中，详细分析了在欧盟五国广泛报销的具体要求和成功因素。获得主要影响者（关键意见领袖和付款方）的早期认可是第一步。同样重要的是提供令人信服的证据，无论是临床证据、卫生经济学（成本效益）证据还是成本节约（预算影响）证明。在一些国家，当地使用数据可能也是一项要求。最后，由于付款方的支付意愿直接源于他们对设备的感知价值，因此对于制造商来说，一个关键的成功因素和必要前提是设定合适的价格。
