药品进入市场:西西里岛区域药物处方的三年经验

V. Pizzimenti, D. Formica, J. Sultana, Simona Lucchesi, A. Aiello, Valentina Ientile, G. Trifirò
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引用次数: 1

摘要

背景:在意大利,药品市场准入取决于欧洲药品管理局(EMA)、意大利国家药品管理局(AIFA)和区域监管程序(西西里药物处方委员会)。西西里区域药物处方委员会的管制和经济成果尚未得到说明。本研究的目的是量化:1)地区批准的药物数量;2)欧洲、国家和地区主管部门的药品审评时间;3)与获批药品相关的区域卫生保健支出。方法:对2013年1月1日至2016年4月1日西西里药品处方委员会批准的所有药品进行鉴定。对于这些药物,分别估计了所有药物和创新药物的欧洲、国家和地区主管部门批准时间的中位数(四分位数范围,IQR)。最后,在药品批准一年后估计区域监管决策的经济影响。结果:共有117种药物获批。EMA和AIFA批准之间的中位(IQR)时间为1.17年(0.93-1.66),而AIFA和西西里地区批准之间的中位(IQR)时间为0.35年(0.27-0.94)。EMA和AIFA之间的创新药审批时间为0.91年(IQR: 0.66-1.75), AIFA和西西里地区审批时间为0.13年(IQR: 0.02-0.25)。区域药物批准与每年525,489,586的成本相关。结论:117个3年批准的药品与每年5.25亿的药品支出相关。西西里岛药品市场准入总时间中位数为1.52年,创新药为1.04年。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Access of medicines to the market: three years' experience of Sicily's regional drug formulary
BACKGROUND: In Italy, pharmaceutical market access depends on European Medicines Agency (EMA), Italian national drug agency (AIFA) and regional regulatory procedures (Sicilian Drug Formulary Committee). The regulatory and economic outcomes of the Sicilian Regional Drug Formulary Committee have not yet been described. The objective of this study was to quantify: 1) the number of drugs approved regionally; 2) the drug review time by European, national and regional competent authorities; 3) regional healthcare expenditure associated with the approved drugs. METHODS: All drugs approved by the Sicilian Drug Formulary Committee between 1st January 2013 to 1st April 2016 were identified. For these drugs, the median (with interquartile range, IQR) approval time taken by the European, national and regional competent authorities were estimated for all drugs and innovative drugs separately. Finally, the economic impact of regional regulatory decisions was estimated one year after drug approval. RESULTS: In total 117 drugs were approved. Median (IQR) time between EMA and AIFA approval was 1.17 years (0.93-1.66), while between AIFA and the Sicilian regional approval this was 0.35 years (0.27-0.94). The time elapsed for innovative drugs was 0.91 years (IQR: 0.66-1.75) between EMA and AIFA and 0.13 years (IQR: 0.02-0.25) between AIFA and Sicilian regional approval. Regional drug approvals were associated with a yearly cost of 525,489,586. CONCLUSIONS: The approval of 117 drugs over 3 years was associated with a 525 million pharmaceutical expenditure yearly. The total median time for pharmaceutical market access in Sicily was 1.52 years, and 1.04 years for innovative drugs.
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