Grilli Roberto, Taroni Francesco
Department of Clinical Governance, Agenzia Sanitaria Regionale Emilia-Romagna, Bologna, Italy.
J Health Serv Res Policy. 2006 Apr;11(2):89-93. doi: 10.1258/135581906776318893.
To explore how the adoption of medical innovations challenges tax-financed health systems, drawing from the case of sirolimus eluting stents, a promising and costly innovation for percutaneous coronary interventions.
The coverage decisions for the new stents adopted in Emilia-Romagna, an Italian region, are described. The innovation was adopted through a process combining the development of clinical guidelines targeting their use to selected clinical indications, negotiation with the manufacturer for reducing price, and the organization of a registry for monitoring its patterns of utilization and assessing its effectiveness.
Overall, 17% of the 6276 patients included in the registry over a 12-month period had the new stent. Wide differences between published trials on sirolimus eluting stents and actual clinical practice emerged. The new stents were frequently (23%) used in combination with traditional bare metal stents, and for indications (acute myocardial infarction and multivessel coronary disease) never included in clinical experiments (25% and 8% of the cases, respectively). Patients' outcomes were also different, the overall rate of major adverse cardiac events being relatively higher (12%) than that shown in clinical trials.
The actions undertaken for the new stents allowed a timely, and at the same time targeted and monitored, adoption of the innovation. This experience highlights how policy decisions related to new medical products could benefit from the availability of clinical databases providing key information on how innovations are actually used and on their impact on clinical practice.
以西罗莫司洗脱支架为例，探讨医学创新的采用如何对税收资助的卫生系统构成挑战，西罗莫司洗脱支架是经皮冠状动脉介入治疗中一项前景广阔但成本高昂的创新技术。
描述了意大利艾米利亚 - 罗马涅地区采用新型支架的覆盖决策情况。该创新技术的采用过程包括制定针对特定临床适应症使用的临床指南、与制造商协商降价以及组织登记处以监测其使用模式并评估其有效性。
在为期12个月的登记期内，登记的6276名患者中，总体有17%使用了新型支架。西罗莫司洗脱支架的已发表试验与实际临床实践之间出现了很大差异。新型支架经常（23%）与传统裸金属支架联合使用，并且用于临床试验从未纳入的适应症（急性心肌梗死和多支冠状动脉疾病）（分别占病例的25%和8%）。患者的结局也有所不同，主要不良心脏事件的总体发生率相对较高（12%），高于临床试验中的发生率。
针对新型支架采取的行动使得该创新技术得以及时、有针对性且受到监测地被采用。这一经验凸显了与新医疗产品相关的政策决策如何能够受益于临床数据库的可用性，这些数据库提供了有关创新技术实际使用方式及其对临床实践影响的关键信息。
