Cancer drugs delayed by up to 14 years – and it’s down to red tape
Cancer patients’ lives are at risk because red tape means it takes 14 years for cutting edge medicines to reach them after being patented, experts have warned.
New cancer drugs are taking longer to get to patients than they did a decade ago because of delays in the drug development and regulatory systems, according to a report by the Institute of Cancer Research.
Drugs that do come through are focused on a tiny minority of cancer types – with not a single new medicine introduced for bladder, brain or oesophageal tumours in nearly two decades.
the youngest patients are also missing out, with only 6 per cent of new cancer drugs since 2000 licensed for children.
Professor Paul Workman, chief executive of the Institute of Cancer Research, said a ‘herd mentality’ among drugs companies is slowing down innovation. the companies are going after the same drugs in the search of profits, he said, meaning very few truly innovative treatments reach the NHs.
‘Cancer patients do better when they are given access to the best treatments as early as possible,’ Professor Workman said last night. ‘Our analysis shows that patients are waiting longer than before for new cancer drugs to become widely available on the NHs. Cancer won’t wait and patients shouldn’t have to either.’
Between 2000 and 2008 it took an average 12.7 years for a cancer drug to go from getting a patent to being approved for NHs patients by drugs watchdog Nice – the National Insti- tute for Health and Care Excellence. Between 2009 and 2016 the time from patent to patient increased to 14.1 years, the report authors found.
‘I don’t think this is about being overcautious about safety – this is regulatory red tape,’
‘Taking new approaches’
Professor Workman said. He warned trials are taking longer because of new regulations over data use and the way studies are conducted. and, even when they are complete, regulators take months to make decisions. Drugs are normally rejected on the grounds of cost effectiveness. Nice has tried to tackle this by starting appraisals earlier – often before licensing has been completed – but decisions have barely sped up. Drugs took an average of 16 months to go through Nice appraisal between 2009 and 2016, compared with 16.7 between 2000 and 2008.
Of 175 drugs given a safety licence between 2000 and 2016, 64 – more than a third – were for blood cancers such as leukaemia and lymphoma. twentythree were for lung cancer and 15 for breast cancer.
Only six were for prostate cancer and four for pancreatic cancer. there were no authorisations at all for brain, oesophageal, bladder or womb cancer. Only ten of the 175 authorisations were for treating children.
Cost effectiveness is the usual reason for not licensing a drug.
Professor Workman said ‘nobody is prioritising innovation’, with pharmaceutical companies each trying to develop almost identical drugs.
Nice is not helping this tendency, approving only 38 per cent of drugs it assessed which work in a completely new way or for a new cancer type – compared to 53 per cent of drugs that are very similar to existing treatments.
Dr Olivia Rossanese of the Institute of Cancer Research, said: ‘We need more drugs taking new approaches to targeting cancer, rather than more of the same “me too” drugs.’