Time to market and patient access to new oncology products in Italy: a multistep pathway from European context to regional health care providers
Time to market and patient access to new oncology products in Italy: a multistep pathway from European context to regional health care providers
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DOI：
10.1093/annonc/mdq097
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发表时间：
2010-10-01
影响因子：
50.5
通讯作者：
Rasi, G.
中科院分区：
文献类型：
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作者：
Russo, P.;Mennini, F. S.;Rasi, G.
方法：对2006-2008年期间由欧洲药品管理局（EMA）批准的一组肿瘤产品进行分析。所探索的顺序阶段包括：EMA上市时间；制药公司;意大利药品管理局（Agenzia Italiana del Farmaco， AIFA）；IRs作为医疗保健的最终提供者。采用Cox回归模型对IR的上市时间进行分析。结果：患者获得所需的总体平均时间为2.3年。EMA占的时间比例较大（31.8%），其次是AIFA（28.2%）。然而，制药公司和IRs的持续时间与最高的变异性相关。一种获得风险分担协议授权的肿瘤学产品显示出在IRs的早期准入。相反，在具有强制性处方集的医疗机构中实行的工作被推迟了。对经济影响的高预测和肿瘤产品的高价格也会延迟患者获得。结论：患者获得肿瘤产品前的过程耗时耗钱。本研究确定了影响意大利市场和患者可及性之间缺失重叠的主要预测因素。
Methods: A panel of oncology products approved by the European Medicines Agency (EMA) in the period 2006-2008 was considered. The explored sequential phases included the times to market for: the EMA; pharmaceutical companies; the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA); and IRs as final providers of health care. The IR's time to market was also analyzed by a Cox regression model.Results: The overall mean time required before patients access was 2.3 years. EMA accounted for the greater proportion of time (31.8%), followed by AIFA (28.2%). However, the duration for both pharmaceutical companies and IRs was associated with the highest variability. An oncology product authorized with a risk-sharing agreement showed an early access in the IRs. On the contrary, the introduction in IRs having a compulsory formulary was delayed. Both a high forecast of economic impact and a high oncology product price can also delay the patient access.Conclusion: The process before patient access to an oncology product is time and cost consuming. This study identifies the main predictors that affect the missing overlap between market and patient access in Italy.