Years delays in highly innovative cancer drugs reaching NHS patients
Although the number of licenced cancer drugs is increasing, the most innovative therapies are reaching patients slower than more conventional treatments, possibly due to a highly risk-averse system which hinders their progress to patients.
A report from The Institute of Cancer Research (London, UK) has found that highly innovative, new cancer drugs going through clinical trials and approval processes are more likely to be delayed or rejected, compared with conventional therapies. Published in the journal Drug Discovery Today, the results of the study show that the most innovative cancer drugs take 3.2 years longer to reach patients through the NHS than low-innovation treatments.
The study analyzed drug approvals over a 16-year period and highlights the different rates at which drugs move from the initial patent being filed to availability on the NHS. The authors categorized drugs as high, medium and low innovation, with the highly innovative drugs identified by having a novel target, mechanism of action or providing treatment for areas of unmet need. Despite initiatives intending to prioritize innovative treatments, these drugs are frequently delayed from the start of the Phase I trial to EMA authorization.
Furthermore, during the study period, NICE gave 38% of highly innovative cancer treatments a positive recommendation, compared with 53% of moderately innovative drugs. This difference may have occurred due to reticence to start appraisals for more innovative drugs; NICE has since committed to appraising all new cancer drugs.
Study leader Paul Workman, Chief Executive of The Institute of Cancer Research, expressed concern that the most exciting treatments with potentially life-changing effects were frequently delayed in reaching patients. He added: "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 recognizing and rewarding innovation."
Delyth Morgan, Chief Executive at Breast Cancer Now (London, UK), released a statement lamenting the delays and the personal impact on patients who do not receive promising new treatments because of the approval process: “It is extremely concerning that NHS cancer patients seem to be waiting longer for access to the best new drugs than ten years ago.”
“Patients living with incurable cancer simply do not have time to lose and it can be unbearably frustrating when promising new medicines that could extend or improve their lives are being left just out of reach on the NHS,” Morgan concluded.
Sharpe E, Hoey R, Yap C, Workman P. From patent to patient: analysing access to innovative cancer drugs. Drug Discov. Today. doi:10.1016/j.drudis.2020.01.004 (2020) (Epub ahead of print);