Concern Over New Cancer Drug Delays

Nicky Broyd

December 04, 2018

We may have a strong track record when it comes to research into cancer but according to a report out today new cancer drugs are taking longer to reach NHS patients.

The analysis, From Patent to Patient , by The Institute of Cancer Research (ICR) looks at access to innovative cancer drugs, and identifies the cancers and the patients that are missing out on advances.

To do this the ICR examined all 97 cancer drugs licensed for 177 indications through the European Medicines Agency (EMA) between 2000 and 2016.

It found that during the years studied, the average time for a cancer drug being patented to it being approved by NICE increased from 12.7 years between 2000-08 to 14.1 years between 2009-16.

Clinical Trials

The report says drug development should be getting faster with smaller, smarter trials but instead it found that the average time taken between the start of phase 1 clinical drug trials and EMA authorisation increased by more than a year from 7.8 years in 2000-08 to 9.1 years in 2009-16.

Dr Olivia Rossanese, head of therapeutics biology at The Institute of Cancer Research, said in a news release: "Our report clearly shows that drugs are taking longer to reach patients when we would expect the process to be getting quicker. With targeted treatments, it should be possible to run smarter, faster trials, and to take a more flexible approach to assessing the results for rapid regulatory approval."

NICE

The report accuses NICE (The National Institute for Health and Care Excellence) of not doing enough and says innovative new drugs are less likely to have been approved for use on the NHS than less innovative treatments.

Professor Paul Workman, chief executive of The Institute of Cancer Research said in a media release: "We 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 says that since the introduction of the Cancer Drugs Fund in 2016, its recommendations/approval rate for cancer drugs has risen from 50% to over 70%.

Responding to the report Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: "We are committed to appraising all new cancer drugs and significant license extensions prospectively, and since the arrangements for the new Cancer Drugs Fund (CDF) were put in place in April 2016 NICE has been able to do this faster than ever before. Patients are now able to access drugs from the point of marketing authorisation where NICE publishes a positive recommendation. For example, last week we issued draft guidance on the drug nivolumab for treating melanoma within days of it receiving its marketing authorisation.

"In order to achieve this, we start our technology appraisal process much earlier in the drug approval pathway. Our aim is to publish draft guidance prior to a drug receiving its marketing authorisation and final guidance within 90 days of marketing authorisation wherever possible."

Unmet Need

Between 2000 and 2016 more than a third of drug authorisations were for blood cancers, 15 drugs were licensed for breast cancer but none at all for brain, oesophageal, bladder or womb cancer, and only one for liver cancer.

The report also found that new drugs were mostly for adults and not children. It says only eight of the 97 drugs authorised by the EMA – and only 10 of 177 drug authorisations – included indications for treating children with cancer. Of these it says only two were for solid tumours, which account for around 60% of new childhood cancer cases each year.
 

Going Forward

The ICR is calling for the Government, regulators and pharmaceutical companies to learn from international best practice to streamline regulation and have smaller, smarter clinical trials. 

It also wants changes in NICE’s system of drug appraisal, to ensure all innovative drugs are appraised, including any that were not appraised before 2016.
 

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