EU Approves Many Oncology Drugs Without Proof of Benefit miragenews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from miragenews.com Daily Mail and Mail on Sunday newspapers.
Objectives To evaluate the added benefit and revenues of oncology drugs, explore their association, and investigate potential discrepancies between added benefit and revenues across different approval pathways of the European Medicines Agency (EMA).
Design Retrospective cohort study.
Setting Oncology drugs and their indications approved by the EMA between 1995 and 2020.
Main outcome measures Added benefit was evaluated using ratings published by seven organisations: health technology assessment agencies from the United States, France, Germany, and Italy, two medical oncology societies, and a drug bulletin. All retrieved ratings were recategorised using a four point ranking scale to indicate negative or non-quantifiable, minor, substantial, or major added benefit. Revenue data were extracted from publicly available financial reports and compared with published estimates of research and development (R&D) costs. Finally, the association between added benefit and revenue was evaluat
High cost oncology drugs without proof of added benefit are burdening health systems bmj.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from bmj.com Daily Mail and Mail on Sunday newspapers.
Two fifths of oncology drugs approved by the EMA over the past 25 years don't offer an added benefit, while their costs may be burdening health systems.