New oncology products : Priceless or Worthless
During last few days there have been two interesting articles on quite different views on this topic.
In an study published in the BMJ, Courtney Davis (King's College, London) and Huseyin Naci (LSE Health) say that 39 (57%) out of 68 cancer indications approved in Europe over a 5 year period till 2013 were sanctioned "without evidence of a survival or quality of life benefit" and were approved based on data derived from unreliable trial designs. They also say that atleast 10 of these approvals have never proved to have any real value for patients. Please do check out article published by John Carroll in Endpoint News :
In another very interesting article, Dr. Luca Dezzani has highlighted the results of a study conducted from Dec 10, 2016 to Mar 2, 2017 for 10 cancer drugs that received approval by the USFDA between 2006 & 2015. The authors conclude that the cost to develop a cancer drug is $ 648 million (versus a usually believed figure in excess of $ 2.5 billion). Additionally, the revenues since approval have also been significant. Please check out the article posted by Dr. Dezzani in LinkedIn :
While cancer research is getting more traction, with more and more companies focusing on this therapy area, fast track approvals by regulatory bodies may see some challenges, especially regarding the quality of data, in light of the increasing criticism by some quarters. Fast track approvals are definitely leading to lower development costs, which in turn lead to lower product prices, and are, therefore, in the interest of all stakeholders.