Trials and approvals delaying new cancer drugs to NHS patients

NICE recommends a CAR T-cell therapy for adults
Credit: Marbury

Delays in clinical trials and approvals means that patients on the NHS are faced with longer wait times for new cancer drugs, a major analysis of regulatory data has revealed.

The analysis found that rapid advances in cancer research have driven a big increase in the numbers of treatments developed – but that efforts to speed up access for patients are not bearing fruit.

A new report by The Institute of Cancer Research, London, also found stark differences in the rate of development of new cancer drugs for different tumour types – with 15 drugs licensed for breast cancer from 2000-16, but none at all for brain cancer.

And the report raises concerns that NICE is not doing enough to ensure the most innovative treatments reach patients – with innovative drugs actually less likely to have been approved for use on the NHS than much less innovative treatments.

The report – ‘From patent to patient – analysing access to innovative cancer drugs’ – examines all 97 cancer drugs licensed for 177 indications through the European Medicines Agency between 2000 and 2016, to assess how successful the system is being at delivering new treatments for patients.

The rate of drug authorisations has almost doubled over the time period – with 7.5 drug indications a year approved by the EMA from 2000-8, compared with 14.6 a year from 2009-16.

But the average time from when a cancer drug is patented to approval by NICE increased from 12.7 years from 2000-08 to 14.1 years from 2009-16, The Institute of Cancer Research (ICR) found.

Expediting drug development

The ICR believes drug development should be getting faster as targeted cancer treatments can be approved through smaller, smarter trials which involve selecting patients based on the genetics of their cancer.

But the report found that the average time taken between the start of phase I clinical trials of a drug and EMA authorisation increased by over a year from 7.8 years in 2000-08 to 9.1 years in 2009-16 – suggesting delays are occurring during trials and licensing.

NICE is starting its appraisals earlier – often before licensing has been completed – but that has not been enough to counteract the pressures that overall are increasing the time for drugs to reach patients.

And NICE has not met its commitment to conduct its appraisals more quickly. Drugs took an average of 16 months to go through NICE appraisal in 2009-2016, barely shorter than the 16.7 months in 2000-08.

The analysis by the ICR also found that cancers of especially high unmet need are often not benefiting from the exciting advances seen in other tumour types.

Some 64 drug authorisations between 2000 and 2016 – over a third of the total – were for blood cancers, and there were an impressive 15 for breast cancer.

But in contrast, there were no authorisations at all for brain, oesophageal, bladder or womb cancer, and only one for liver cancer.

Only eight of the 97 drugs authorised by the EMA – and only 10 of 177 drug authorisations – included indications for treating children with cancer.

Only two of these drugs were for solid tumours, which account for around 60 per cent of new childhood cancer cases each year and are often harder to treat than childhood blood cancers.

The analysis also highlighted the ICR’s world-leading contribution to the discovery and development of cancer drugs. The ICR has been directly involved in around one in five of the cancer drugs licensed by the EMA since 2000.

The ICR’s report found that NICE now needs to do more to deliver the most innovative drugs to patients.

Innovation is vital

A highly innovative drug is less likely to have been approved by NICE than a low-innovation drug.

Only 38% of EMA authorisations for high-innovation drugs had been approved by NICE at the point of our analysis compared with 40% of moderate-innovation and 53% of low-innovation drugs.

The ICR believes this could be because NICE’s definition of innovation is limited to effectiveness in areas of unmet need and does not also sufficiently value the need to bring through truly innovative drugs that attack cancers in brand new ways.

Innovation is vital to deliver step-change improvements in patient care, in part by giving us new ways of combining treatments to combat cancer’s evolution and drug resistance.

There are concerns that some innovative drugs have missed out on NICE appraisal entirely.

NICE had completed appraisals for 107 of the 177 drug indications over the time period, with some others either in progress or terminated early.

Of the remaining 70 that had not had a completed appraisal, 51 drug indications had not been assessed at all at the time of our analysis. Of those 51 drug indications not appraised by NICE, the ICR found 32 were highly innovative medicines.

NICE committed in 2016 to appraise all new licenced indications for cancer drugs, but the findings raise concerns that significant numbers from before this date may have slipped through the net or been subjected to substantial delays.

The ICR is now calling for the Government, regulators and pharmaceutical companies to work together to accelerate the pace of development of innovative cancer treatments, by learning from international best practice to streamline regulation and by embracing smaller, smarter clinical trials.

It is also pushing for changes in NICE’s system of drug appraisal, to ensure all innovative drugs are appraised, including any that were not appraised before 2016, and that their degree of scientific innovation is properly taken into account.