OSMED Office, Italian Medicines Agency.
CEIS Sanità (Centre for Health Economics and Management), Faculty of Economics, University 'Tor Vergata' Rome; Faculty of Statistics, University 'La Sapienza' Rome.
Ann Oncol. 2010 Oct;21(10):2081-2087. doi: 10.1093/annonc/mdq097. Epub 2010 Mar 24.
The main purpose of this study was to identify each sequential phase followed by an oncology product, from European assessment until to patient access in each Italian region (IR).
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.
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.
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.
本研究的主要目的是确定从欧洲评估到意大利各地区（IR）患者获得药物的每个连续阶段。
考虑了在 2006 年至 2008 年期间被欧洲药品管理局（EMA）批准的一组肿瘤学产品。探索的连续阶段包括在 EMA；制药公司；意大利药品管理局（Agenzia Italiana del Farmaco，AIFA）；以及作为医疗保健最终提供者的 IR。还通过 Cox 回归模型分析了 IR 的市场进入时间。
患者获得药物前的总平均时间为 2.3 年。EMA 占了更大的时间比例（31.8%），其次是 AIFA（28.2%）。然而，制药公司和 IR 的持续时间都与最高的可变性相关。具有风险分担协议的肿瘤学产品在 IR 中获得早期进入。相反，在强制性处方集的 IR 中引入则被推迟。高经济影响预测和高肿瘤产品价格也会延迟患者获得药物。
肿瘤学产品获得患者前的过程既耗时又费钱。本研究确定了影响意大利市场和患者获得药物之间缺失重叠的主要预测因素。
