Almost two thirds (57%) of cancer drugs authorised by the European Medicines Agency (EMA) between 2009 and 2013 came onto the market without any clear evidence they improved the quality or quantity of patients’ lives, according to research from the London School of Economics and Political Science (LSE) and King’s College London, published in the BMJ today (Thursday 5 October).
The research team found most cancer drugs are approved by the EMA using only surrogate measures which, although indicators, are not strong predictors of survival – whether living longer or feeling better.
This low level for authorisation means a significant number of cancer drugs, available on the European market and often promoted as ‘breakthrough therapies’, may have no actual demonstrable benefit over existing treatment options or placebo. This may lead to false hope and exposure to unnecessary drug toxicity for some patients as well as being a significant waste of important resources and funding.
Huseyin Naci, Assistant Professor in LSE’s Department of Health Policy, and one of the authors of the study, said: ‘It is remarkable that so few cancer drugs enter the European market with any clear data on outcomes that matter to patients and their doctors: longer survival and better quality of life. There is a clear need to raise the bar for approving new cancer drugs.’
The team also found that even after a median follow-up of five years, almost half of the drugs (49%) still showed no quality or quantity of life benefit and of those that did, these benefits were judged to be clinically insignificant around 50% of the time.
Dr Courtney Davis, a medical and political sociologist in the Department of Global Health and Social Medicine at King’s College London, lead author of the study, said: ‘We evaluated the evidence base for all new drugs entering the market over a 5 year period and found that the majority came onto the market without clear evidence that they improved patients’ survival or quality of life. A large number of people are undergoing treatment for cancer and little new information is available to guide patients and their treating clinicians regarding drug effectiveness. When expensive drugs that lack robust evidence of clinical benefit are approved and reimbursed within publicly funded healthcare systems, individual patients may be harmed and public funds wasted. ’
As a result of these findings, the researchers are calling on the EMA to increase its evidence bar for the market authorisation of new drugs.
Availability of evidence on overall survival and quality of life benefits of cancer drugs approved by the European Medicines Agency: A retrospective cohort study of drug approvals from 2009-2013 is available here: http://www.bmj.com/content/359/bmj.j4530.