PDF(Pubmed)
Abstract：
Despite the availability of affordable pharmaceuticals treating cardiovascular diseases (CVDs), many of the risk factors remain poorly controlled. Fixed-dose combinations (FDCs), a form of incremental innovation, have already demonstrated improvements over combinations of single medicines in adherence and hard clinical endpoints. Nevertheless, there are many barriers related to the wider use of FDCs in CVDs. Our aim was to identify these barriers and explore system-level facilitators from a multi-stakeholder perspective. Identified barriers include (i) hurdles in evidence generation for manufacturers, (ii) limited acceptance of adherence as an endpoint by clinical guideline developers and policymakers, (iii) limited options for a price premium for incremental innovation for healthcare payers, (iv) limited availability of real-world evidence, and (v) methodological issues to measure improved adherence. Initiatives to standardize and link healthcare databases in European countries, movements towards improved patient centricity in healthcare, and extended value assessment provide opportunities to capture the benefits of FDCs. Still, there is an emerging need to facilitate the generalizability of sporadic clinical evidence across different FDCs and to improve adherence measures. Finally, healthcare payers need to be convinced to pay a fair premium price for the added value of FDCs to incentivize incremental innovation in CVD treatment.
摘要：
尽管有负担得起的治疗心血管疾病（CVDs）的药物，许多风险因素控制不佳。固定剂量组合（FDC），一种渐进创新的形式，已经证明在依从性和硬临床终点方面优于单一药物组合。然而，在心血管疾病中广泛使用FDC存在许多障碍。我们的目标是确定这些障碍，并从多利益相关者的角度探索系统级促进者。确定的障碍包括(I)制造商证据生成的障碍，（ii）临床指南开发人员和政策制定者对依从性作为终点的接受程度有限，(iii)医疗保健支付者增量创新的价格溢价选择有限，(Iv)真实世界证据的可用性有限，和(五)衡量依从性提高的方法学问题。在欧洲国家标准化和链接医疗保健数据库的举措，在医疗保健中改善以患者为中心的运动，和扩展的价值评估提供了获取FDCs好处的机会。尽管如此，越来越需要促进不同FDC之间的散发性临床证据的普遍性,并改善依从性措施.最后,需要说服医疗保健支付者为FDC的附加值支付公平的溢价，以激励CVD治疗的增量创新。
