Baird L G, Banken R, Eichler H-G, Kristensen F B, Lee D K, Lim J C W, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, Hirsch G
Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Institut national d'excellence en santé et en services sociaux, Québec, Canada.
Clin Pharmacol Ther. 2014 Nov;96(5):559-71. doi: 10.1038/clpt.2014.145. Epub 2014 Jul 9.
There is broad agreement among health-care stakeholders that more must be done to ensure that patients have timely access to new and innovative medicines. Assuming that industry will continue to develop such medicines at a sustainable rate, regulators and payers become the gatekeepers. Regulators, starting in the late 1980s/early 1990s, and, more recently, payers have implemented a variety of early-access pathways or initiatives, and this practice is continuing even today. This article describes the specific approaches that have been taken in four economically developed regions, reviews their success rates, and suggests possible new directions.
医疗保健领域的利益相关者普遍认为，必须采取更多措施，以确保患者能够及时获得新型创新药物。假设制药行业将继续以可持续的速度研发此类药物，那么监管机构和支付方就成为了把关者。从20世纪80年代末/90年代初开始，监管机构，以及最近的支付方，已经实施了各种早期准入途径或举措，而且这种做法至今仍在继续。本文介绍了四个经济发达地区所采取的具体方法，评估了它们的成功率，并提出了可能的新方向。
