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From patent to patient: analysing access to innovative cancer drugs.
Drug Discovery Today ( IF 6.5 ) Pub Date : 2020-01-29 , DOI: 10.1016/j.drudis.2020.01.004
Eva Sharpe 1 , Richard Hoey 1 , Christina Yap 1 , Paul Workman 1
Affiliation  

Analysis of cancer drugs licensed through the European Medicines Agency (EMA) in 2000–2016 shows that the number of authorisations increased over that timeframe. The median number of licensed drugs each year rose from six for 2000–2008 to 13.5 for 2009–2016. Over 2000–2016, there were 64 drug authorisations for haematological, 15 for breast, and 12 for skin cancer, but none for oesophageal, brain, bladder, or uterine cancer. Only 6% of authorisations included a paediatric indication. The average time for a drug to progress from patent priority date to availability on the National Health Service (NHS) increased from 12.8 years for drugs first licensed in 2000–2008 to 14.0 years for those licensed in 2009–2016. There was evidence that the most innovative drugs were not being prioritised for EMA licensing and NICE approval.



中文翻译:


从专利到患者:分析创新癌症药物的获取情况。



对 2000 年至 2016 年通过欧洲药品管理局 (EMA) 许可的抗癌药物的分析表明,授权数量在此期间有所增加。每年获得许可的药物数量中位数从 2000-2008 年的 6 种增加到 2009-2016 年的 13.5 种。 2000年至2016年期间,有64个血液癌药物授权,15个乳腺癌药物授权,12个皮肤癌药物授权,但没有一个用于食管癌、脑癌、膀胱癌或子宫癌药物授权。只有 6% 的授权包括儿科适应症。药物从专利优先权日到国家医疗服务体系 (NHS) 提供的平均时间从 2000 年至 2008 年首次获得许可的药物的 12.8 年增加到 2009 年至 2016 年获得许可的药物的 14.0 年。有证据表明,最具创新性的药物并未优先获得 EMA 许可和 NICE 批准。

更新日期:2020-01-29
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