Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, School of Medicine, Tufts University, Boston, Massachusetts, USA.
Health Aff (Millwood). 2013 Jun;32(6):1109-15. doi: 10.1377/hlthaff.2012.1073.
The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.
美国食品和药物管理局（FDA）和医疗保险采用不同的标准来确定，首先，一种新药或医疗器械是否可以向公众销售，其次，如果联邦医疗保险计划是否将支付该药物或设备的使用费用。这种差异给药品和医疗器械制造商带来了障碍和不确定性。我们分析了 1999 年至 2011 年间批准的 69 种器械和 B 部分药物的 FDA 批准和医疗保险国家覆盖范围决定之间的差异。我们发现，医疗保险涵盖了 FDA 批准的药品或器械的 80%。然而，医疗保险经常在 FDA 批准的基础上增加条件，特别是对于器械，而且通常将覆盖范围限制在患有最严重疾病的患者。在某些情况下，医疗保险的限制比 FDA 少。我们的研究结果强调了药品和医疗器械制造商在进行支持其产品的临床研究时，预测医疗保险需求的重要性。我们的研究结果还为 FDA 和医疗保险的试点平行审查计划提供了重要的见解。
