Center for Translational Nuclear Medicine and Molecular Imaging, Department of Radiology, Massachusetts General Hospital, Charlestown, Massachusetts 02129, USA.
J Nucl Med. 2013 Mar;54(3):329-32. doi: 10.2967/jnumed.112.107615. Epub 2013 Jan 28.
Radioactive imaging agents, like diagnostic drugs generally, undergo a drug development process that parallels that of therapeutic agents, with similar development times but substantially lower development costs and substantially smaller postapproval markets. Although rapid advances in genetic and expression profiling are furthering the development of expensive pharmacotherapies targeted to small patient populations, the commercial development of imaging agents for small patient populations is blocked by the limited revenues available with current per-dose pricing and the relatively small numbers of imaging procedures that would be performed. A wide-ranging discussion on the best approaches to allow new diagnostic imaging agents to become part of the health-care system, and benefit the patient, is needed.
放射性成像剂与一般的诊断药物一样，经历了与治疗药物相似的药物开发过程，具有相似的开发时间，但开发成本要低得多，批准后的市场规模也要小得多。尽管基因和表达谱的快速发展进一步推动了针对小患者群体的昂贵药物治疗的发展，但由于当前每剂量定价的收入有限，以及成像程序的相对数量较少，小患者群体的成像剂的商业开发受到阻碍。需要广泛讨论允许新的诊断成像剂成为医疗保健系统的一部分并使患者受益的最佳方法。
