New cancer drugs are taking too long to be approved by NHS

Cancer treatment with new drugs is lagging in Britain because NHS watchdogs take too long to approve them, experts have warned

• Most innovative drugs took more than three years longer to get to NHS patients
• Institute of Cancer Research said strict regulations are forcing patients to wait
• Drugs take up to 20 years to reach patients because regulators too ‘risk averse’  

Cancer treatment is lagging in Britain because NHS watchdogs take too long to approve some of the best new drugs, experts have warned.

An increasing numbers of medicines have been licensed since 2000 to target new mutations in cancer.

But some are taking more than 20 years to reach NHS patients because regulators are ‘too risk adverse’, The Institute of Cancer Research said. 

It compared how quickly innovative and ‘exciting’ drugs go through approval with those considered more standard.

The most innovative cancer drugs took more than three years longer from filing the patent through to NHS patients.

Experts said strict regulations are robbing patients of drugs that had the potential to ‘transform’ their lives. 

Cancer treatment with some of the best new drugs is lagging in Britain because NHS watchdogs take too long to approve them, experts have warned 

Study leader Professor Paul Workman, Chief Executive of The Institute of Cancer Research, said the study demonstrated that drug regulation was not keeping pace with advances in science.

He said: ‘It is taking longer for new drugs to reach patients and, alarmingly, the delays are longest for the most exciting, innovative treatments, with the greatest potential to transform the lives of patients.

‘At the moment the whole ecosystem for drug discovery and development – involving regulators, researchers and companies – is too risk averse.’  

There are around 363,000 new cases of cancer in the UK each year, with a further 1.8million in the US.

Cancer can evolve and become resistant, making targeted cancer treatments that were initially effective of less use. 

Innovative new treatments are needed as a result, and are invaluable if it means someone with resistant forms of the disease can be given more time. 

In England and Wales, new drugs must pass through clinical trials and authorisation, and be approved as cost-effective for use on the NHS by the watchdog National Institute for Health and Care Excellence (NICE).

WHAT WAS IN THE ICR’S MANIFESTO TO IMPROVE ACCESS TO DRUGS? 

Last year, the Institute of Cancer Research published a ten-point manifesto called for NICE, the body which approves drugs in the UK, to prioritise genuinely innovative cancer treatments which attack cancer in brand new ways.   

It said drug regulators need to be more flexible in assessing evidence, so that new treatments can reach patients as quickly as possible.

And it called for radical action to bring down the high prices of modern cancer drugs – such as tying prices to the benefits that treatments deliver, so that as many patients as possible can benefit from research advances.

The manifesto also warned there is very little drug discovery research for children’s cancer and that there are far too few clinical trials – limiting access to the latest life-saving or life-extending treatments.

There needs to be more flexibility on the age limits for clinical trials to avoid denying older children and young adults access to new treatments simply because they are judged too young or old.

But Professor Workman and his team warned that the UK’s entire system for drug discovery and development is too cautious.

In the study, which was published in the journal Drug Discovery Today, the researchers looked at drugs licensed by the European Medicines Agency (EMA) from 2000 until 2016.

They assigned each drug one of three categories of innovation – high, medium or low.

The highly innovative category included drugs which worked in a different way to previous drugs, or those which targeted a different aspect of a cancer than previously.

The researchers found the most innovative drugs took 14.3 years to become available on the NHS, compared with 13.5 years for medium-innovation drugs and 11.1 years for the least innovative treatments. 

Some of the most innovative drugs took more than 20 years to reach patients. 

Mifamurtide, which is used to treat osteosarcoma, a type of bone cancer, took 20 years to be approved by NICE after being patented. 

And trabectedin, under the brand name Yondelis for the treatment of soft tissue carcinoma, took 22 years to go through the approval process. 

More recently, a drug used to treat breast cancer, olaparib, also called by its brand name Lynparza, is waiting to be approved since it was authorised by the EMA last April. It’s already available in the US.

The findings also show the time it took between a patent being filed to availability on the NHS increased between 2000 and 2016.

Drugs first patented from 2000-2008 took 12.8 years to reach patients. 

This rose to 14 years for drugs first licensed between 2009 and 2016. 

More positively, Professor Workman and his colleagues found that the rate of drugs licensed by the EMA has doubled, increasing from an average of six per year from 2000-08, to 13.5 per year from 2009-16.

There were large numbers of EMA authorisations for certain cancers, such as skin and breast, but none for others, such as brain and oesophageal cancer, which have ‘very high unmet need’.

The team wrote: ‘We found that the more highly innovative drugs did not progress faster through development.

‘In fact, we observed that the higher the level of innovation assigned to a drug, the longer on average it took to move from patent priority date to NICE final appraisal determination.’

They added: ‘Of concern, in view of the need for drugs that work in new ways, our findings suggest that the system for NICE appraisal has not given priority to approving the most innovative cancer medicines.’

Some of the blame lies with EMA, because much of the delay occurred between the start of a phase I trial and the treatment being approved by the EMA.

It took 8.9 years for the most innovative drugs compared with 6.8 for the least innovative.  

The researchers found that NICE had made improvements – the time between the treatment being approved by the EMA and NICE starting its technology appraisals had reduced.

However, the data showed it was not getting any faster at carrying out the appraisals.

The body was also less likely to approve drugs regarded as highly innovative, with just 38.4 per cent being approved.

Drugs in the middle tier of innovation saw a 53.3 per cent approval rate, while 40.1 per cent of the lowest tier drugs were approved.   

The researchers called for the regulations governing clinical trials and licensing to be loosened and they also hope that drug companies are given stronger incentives to produce the most exciting drugs.   

They also suggest that the Medicines and Healthcare Products Regulatory Agency (MHRA) and EMA should adapt their approaches to regulation to make it easier to bring treatments to patients.

Professor Workman said: ‘Our study details the major progress being made against cancer, with the average number of drugs being licensed each year more than doubling over the last decade.

‘But it also makes clear that our regulatory systems are not keeping pace with advances in the science.’ 

The ICR’s report comes after the body warned last year that warned that cancer drugs are not reaching patients who need them.  

One in six people diagnosed with cancer have faced problems getting the drugs recommended by their doctors, according to their earlier findings, which were reported in April. 

They found that NHS rationing, red tape and hold-ups mean 16 per cent of patients have either faced delays getting cancer treatments or been denied them altogether, polling by the organisation has found.

They published a ten-point manifesto calling for action to improve drug access.  

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