Prostate cancer breakthrough must wait for publication, says NHS England


Groundbreaking, low-cost treatment which dramatically extends the lives of prostate cancer patients won't be recommended until after trial results are published in a peer reviewed journal, NHS England has said.

Earlier this week pharmaphorum exclusively revealed that NHS leaders are delaying judgement on compelling evidence for using docetaxel earlier to treat men with metastatic prostate cancer.

Results from the STAMPEDE trial found that men with metastatic disease given the off-patent chemotherapy earlier saw their lives extended by an average of 22 months compared to standard treatment.

The results, first announced in May, represent a huge step forward in improving survival for thousands of men in the UK – but NHS England has now confirmed that it will only act once the data has been published in a peer reviewed journal.

Responding to pharmaphorum's story, an NHS England spokesman said: "The policy proposal has not been declined. Decisions such as these have to be made based on good quality clinical evidence.

"We've committed to developing a policy once that evidence becomes available, which at this stage means waiting for the publication of two clinical trials."

But the STAMPEDE trial chief investigator Professor Nick James says the delay is unnecessary and called for NHS England to show a more 'flexible' approach to the remarkable results. He says NHS budget holders can weigh up the evidence themselves before peer review publication.

Prof James says the NHS England response doesn't take into account the overwhelming evidence behind early docetaxel use – or the low cost of the drug, which is off-patent.

"I can see that as a concern with new high priced drugs, where they think it will give the oncologists a blank cheque to bankrupt the system, but that's not the case with docetaxel."

Prof James said he and his team were happy to share their full dataset with NHS England to help accelerate the decision.

Regional variations opening up

Meanwhile, some cancer specialists in some hospitals are simply introducing the earlier treatment without approval from budget holders, but other areas are waiting. This means men in some areas are missing out on many months of extra life.

The decision is at odds with a shift towards accelerated approval of new cancer medicines – which are increasingly being approved and funded before they demonstrate any overall survival data.

One reason for NHS England's reluctance to give the green light is that spending on chemotherapy and cancer services is one of the fastest growing in the health service. However because docetaxel is off-patent, its cost is a fraction of new patented treatments.

NHS England points to another study, GETURG15, conducted in France, which concluded that earlier docetaxel use was not beneficial. However there is a growing consensus that the other two studies represent a truer picture of the drug's benefits.

NHS England wants to see STAMPEDE and another similar study, CHAARTED, published before it will make a decision. CHAARTED will be published in the next fortnight in the New England Journal of Medicine, while Prof James and his team are preparing their research for peer review publication, but it will take many more months before this process is complete.

Wider problem

The difficulty in getting the STAMPEDE findings taken up by the NHS is part of a recurring problem with off-patent drugs. Campaigners say that because there is no pharmaceutical company holding a licence and pushing for uptake, major breakthroughs discovered in academic research are often left to 'sit on the shelf'.

MP Nick Thomas-Symonds recently introduced the Off-patent Drugs Bill to Parliament, with the hope of compelling the government and the NHS to overcome the barriers to implementing such findings. Another groundbreaking study, this time in breast cancer, was published today in The Lancet.

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