Innovative cancer drugs are taking longer to get to patients due to delays in clinical trials and regulatory red tape, new data shows.
Cancer drugs
A report by the Institute of Cancer Research (ICR), London, looked at the all the cancer drugs licensed on the European Medicines Agency’s between 2000-2016, examining the changing trends in drug discovery for particular types of cancers.
The report examined the speed at which drugs are moving throughout development, from their initial discovery to authorisation and appraisal by the EMA and NICE.
It found that though there has been a big increase in the number of cancer treatments developed, the speed at which patients are receiving these treatments hasn’t improved.
In particular, the average time for a cancer drug’s approval by NICE has increased by almost two years, the report found, even though the rate of drug authorisations has almost doubled.
The ICR has stated that drug development should be getting quicker, as smarter clinical trials begin to target patients based on the genetics of their cancer.
However, the average time between the start of clinical trials and EMA authorisation has increased from 7.8 years in 2000-2008, to 9.1 years in 2009-2016. The ICR believes that delays during trials and licensing might be the cause of the increased time taken for authorisation
Whilst NICE has been starting its approvals earlier, the analysis argues that not enough has been done to counteract the pressures that are contributing to the increase in time for drugs reaching patients. The report also states that NICE has not met its commitment to conduct drug appraisals more quickly. Through 2009-2016, drugs took an average of 16 months to go through NICE, a minimal improvement compared to the 16.7 months in 2000-2008.
More so, certain types of cancer haven’t had any new drugs licensed for them in over 15 years. A third of the drug authorisations were for blood cancers and breast cancer received 15. However, there none at all for brain, oesophageal, bladder or womb cancer, and only one for liver cancer. Only 38% of EMA authorisations for high-innovation drugs were approved by NICE, compared to 40% of moderate-innovation and 53% of low-innovation drugs.
The ICR is also concerned that NICE might have missed certain innovative drugs from its appraisals. Over the time of the study, NICE had appraised 107 of 177 drugs, with others in-progress or terminated early. From those remaining, 51 drugs had not been assessed by NICE, with 32 being highly innovative medicines.
Worse still is that cancers of especially high unmet need are not benefitting from the advances being made in other tumour types.
The report also found that NICE isn’t doing enough to bring innovative treatments to patients as innovative drugs are less likely to be approved for use on the NHS.
Only eight of the drugs authorised by the EMA were for treating children with cancer, and only of two of these drugs were for solid tumours, which are harder to treat than childhood blood cancers.
The ICR is now calling for government, regulators and pharmaceutical companies to collaborate on accelerating the development of innovative cancer treatments, by utilising best practice to streamline regulation and by embracing smarter and smaller clinical trials.
The group is also arguing for a change in NICE’s system of drug appraisal so it ensures all innovative drugs are appraised, including those that were not appraised before 2016.
Professor Paul Workman, chief executive of the Institute of Cancer Research, London, said: “Our analysis gives us a vivid picture of the state of the nation in cancer drug discovery, development, licensing and appraisal.
“It’s great news that the incredible scientific advances we have seen over the last decade are fuelling an increase in the rate of drug discovery and development, but it’s clear that we need to do so much more to get innovative new treatments to patients.
“The future of cancer drug development lies in smaller, smarter, streamlined clinical trials, so it is frustrating to see the journey to patients slowing down when it should be speeding up.
“We need to address the regulatory barriers in setting up and running clinical trials, and in getting drugs licensed at as early a stage as possible. We need academia to play a leadership role in encouraging drug companies to bring forward new models of trials as quickly as possible.
“We also need NICE to place much more emphasis on innovation in assessing new cancer drugs, so we can give patients access to exciting new treatments that attack cancers in brand new ways.
“We need genuinely novel drugs that deliver step-change benefits either on their own or in combination – in order to meet the major clinical challenge of cancer evolution and drug resistance.”