Cancer drugs take 22 years to be approved
“BREAKTHROUGH” cancer drugs that can extend lives are taking up to 22 years to reach patients on the NHS, a major study has found.
The research by British scientists found that the most innovative treatments – which can radically overhaul the way diseases are treated – take far longer than conventional drugs to get the green light.
The study by the Institute of Cancer Research examined all cancer drugs licensed by European watchdogs over a 16-year period. It found that between 2009 and 2016, it had taken an average of 14 years for treatments to become available on the NHS since the patent was filed. The situation was even worse than it had been between 2000 and 2008, when it took 12.8 years.
The more innovative a drug was, the longer it took to be funded on the NHS – on average, innovative drugs took just over three years longer than conventional treatments to get to patients.
Cases highlighted in the study include a drug called trabectedin, which can extend the lives of those with advanced soft tissue carcinoma. It took 22 years from it being patented to getting the go-ahead from the National Institute for Health and Care Excellence (Nice).
Another drug used to treat bone cancer took 20 years to reach this stage, while breast cancer drug olaparib, which got the go-ahead from the US Food and Drink Administration more than two years ago, has yet to be appraised by NHS watchdogs.
The report’s authors called on Nice to overhaul its systems, to give more priority to approving breakthrough medicines. Researchers also called for an overhaul of regulation of clinical trials and drug licensing, so that promising breakthrough drugs are more speedily fast-tracked.
In England and Wales, new drugs must pass through clinical trials and authorisation, and be approved as costeffective by Nice before they are routinely used on the NHS.
Study leader Prof Paul Workman, chief executive of The Institute of Cancer
Research, London, said the UK’S regulatory systems were not keeping pace with advances in science.
He said: “It is taking longer for new drugs to reach patients and, alarmingly, the delays are longest for the most exciting, innovative treatments, with the greatest potential to transform the lives of patients. At the moment, the whole ecosystem for drug discovery and development – involving regulators, researchers and companies – is too risk averse.”
The study, published in the journal Drug Discovery Today, provides an overview of access to all drugs licensed through the European Medicines Agency (EMA) from 2000 to the end of 2016.