Schaefer Elmar, Schnell Gerald, Sonsalla Jessica
InsuLine Medical GmbH, Mannheim, Germany.
Simon-Kucher & Partners, Cologne, Germany
J Diabetes Sci Technol. 2015 Jan;9(1):156-61. doi: 10.1177/1932296814561288.
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.
在欧洲推出下一代或创新型医疗设备的制造商面临着非常多样化的报销情况，每个国家都有自己的途径、时间安排、要求和成功因素。我们选择了两个市场来更深入地研究报销情况：法国，代表一个通过明确流程进行中央决策的国家；以及意大利，该国将报销决策下放到地区层面，导致报销方式缺乏透明度。基于我们在参与各种新产品推出工作以及分析近期报销决策方面的经验，我们发现这两个国家的支付方都不会因下一代产品的改进而给予增量报销。审视创新情况时，我们注意到制造商在获得报销方面面临着具有挑战性且漫长的过程。此外，各国的要求和关键成功因素也有所不同：在法国，比较临床证据和预算影响在定价和限制方面对报销决策起着很大的推动作用，而在意大利，地区关键意见领袖（KOL）的支持和额外的本地观察数据则是关键。
