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Red tape delaying availability of new cancer drugs

Report also criticises NICE for lack of emphasis on innovation when assessing new drugs

Ingrid Torjesen

Tuesday, 04 December 2018

NHS patients are waiting for new cancer drugs because of delays in taking them through clinical trials and getting them approved for use, a report* by The Institute of Cancer Research (ICR) says.

The report found that there are stark differences in the rate of development of new cancer drugs for different tumour types and also raises concerns that the National Institute for Health and Care Excellence (NICE) is not doing enough to ensure the most innovative treatments reach patients.

The report examines all 97 cancer drugs licensed for 177 indications through the European Medicines Agency (EMA) between 2000 and 2016.

It found that the rate of drug authorisations 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 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.

It also points out stark differences in the rate of development of new cancer drugs for different tumour types. Some 64 drug authorisations between 2000 and 2016 – over a third of the total – were for blood cancers, and there were 15 for breast cancer, but 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 included indications for treating children with cancer. Only two of these drugs were for solid tumours, which account for around 60% of new childhood cancer cases each year.

The ICR’s report found that NICE now needs to do more to deliver the most innovative drugs to patients. Only 38% of EMA authorisations for high-innovation drugs had been approved by NICE 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.

Professor Paul Workman, chief executive of ICR, London, said: “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.”

He added: “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.”

"NICE isn’t prioritising the most innovative drugs.”

*From Patent to Patient: Analysing access to innovative cancer drugs. A report prepared by The Institute of Cancer Research, December 2018.

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