NHS Patient Delay for Breakthrough Cancer Drugs

Peter Russell

January 29, 2020

Highly innovative cancer drugs took longer to reach NHS patients than more conventional treatments, a study found.

The higher the level of innovation of a cancer drug, the longer it was taking to pass through clinical trials, licensing, and appraisal researchers said.

The analysis of cancer drugs licensed through the European Medicines Agency (EMA) between 2000 and 2016 showed that increasing numbers of cancer drugs were licensed but that treatments were taking longer to progress through trials and approval.

They warned that the system of drug discovery and development – including researchers, companies, and regulations – was too risk averse.

Fourteen Year Delay

Analysts from the Institute of Cancer Research (ICR) said that during the timespan there were 64 drug authorisations for haematological, 15 for breast, and 12 for skin cancer, but none for oesophageal, brain, bladder, or uterine cancer. Also, there were just 6% of authorisations which included a paediatric indication.

The average time for a drug to become available on the NHS was 14 years, up from 12.8 years in 2000–2008.

The analysis, featured in the journal Drug Discovery Today, said "there was evidence that the most innovative drugs were not being prioritised for EMA licensing and NICE approval".

To reach their conclusions, they assigned each drug to one of three categories of innovation – classed as high, medium, or low.

The researchers said that the most innovative cancer drugs took 3.2 years longer to go through the process of patent filing to NHS use than low-innovation treatments.

It suggested that initiatives intended to prioritise the most innovative drugs had yet to be effective, they said.

Much of the delay seemed to occur in the period from the start of a phase I trial through to EMA authorisation - which lasted an average of 8.9 years for the most innovative drugs compared with 8.7 years for medium-innovation drugs and 6.8 years for the least innovative.

The researchers called for improvements in patient access to innovative treatments by streamlining regulations on clinical trials and licensing, and more strongly incentivising innovation in drug discovery and development.

"We encourage NICE to fast track appraisals of the most mechanistically innovative cancer drugs and to take into account their degree of innovation in deciding whether they should be approved for patients on the NHS", they wrote.

Regulatory System 'Not Keeping Pace'

Prof Paul Workman, chief executive of the ICR, said: "Our study details the major progress being made against cancer, with the average number of drugs being licensed each year more than doubling over the last decade. But it also makes clear that our regulatory systems are not keeping pace with advances in the science. 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. It's crucial that academic researchers and pharmaceutical companies should feel that the regulatory systems for drug development support risk taking and innovation, rather than discouraging it and slowing it down.

"Our study raises questions in particular for the processes in the UK and Europe for regulating clinical trials and licensing, which need to do better at recognising and rewarding innovation.

"As the ICR begins an exciting new 'Darwinian' programme of drug discovery to combat cancer evolution and drug resistance, we are calling on Government, regulators and industry to together reshape the cancer therapeutics ecosystem, so the best new treatments can progress to patients much more quickly."

From patent to patient: analysing access to innovative cancer drugs, Drug Discovery Today. Published online 29th January 2020. https://doi.org/10.1016/j.drudis.2020.01.004

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