The costly cancer drugs that don’t help patients

Most cancer drugs given a European medical licence do nothing to extend or improve the lives of patients, a study has concluded.

Researchers found this was true of 57 per cent of treatments approved by the European Medicines Agency between 2009 and 2013.

Many were provided in Britain through the Cancer Drugs Fund.

Most cancer drugs given a European medical licence do nothing to extend or improve the lives of patients, a study has concluded (Stock image)

Even when drugs did show survival gains over existing treatments, the benefits were marginal, the study said. Treatments that did improve life expectancy gave patients only an extra 2.7 months on average, often at the cost of thousands of pounds.

The researchers, from King’s College London and the London School of Economics, said drugs firms were giving patients false hope and exposing them to needless side effects.

‘There is a clear need to raise the bar for approving new cancer drugs,’ said Huseyin Naci of LSE. ‘It is remarkable that cancer drugs enter the European market without any clear data on outcomes that matter to patients and their doctors: longer survival and better quality of life.’

Approval by the EMA allows drugs companies to market and sell their medicines across Europe, including in Britain.

Treatments under scrutiny 

DRUG: Everolimus for breast cancer

COSTS: £18,293 for an average 5.5-month course

Made by Novartis, sold under the trade name Afinitor. Approved by the EMA in 2012 without survival data or quality of life data. 1,500 women a year are thought to be eligible. Moved on to routine provision through NICE in 2016. Trials show it stops the cancer spreading for an average of four months.

DRUG: Bosutinib for chronic myeloid leukaemia

COSTS: £45,000 a year

Made by Pfizer under the name Bosulif. Approved by EMA in 2013 with no evidence it extended life. 80 patients a year are thought to get it on the NHS. Up to 85 per cent of patients see white blood cells return to normal levels.

DRUG: Panitumumab for bowel cancer

COSTS: £54,000 a year

Made by Amgen and sold under the trade name Vectibix. Approved by the EMA in 2011, initially with no evidence it extended life. 84 NHS patients a year are thought to benefit. Made routinely available by NICE in 2017. More recent data suggests it boosts survival by ten months more than other treatments.

DRUG: Bevacizumab for breast cancer

COSTS: £42,000 a year

Made by Roche, Sold under the trade name Avastin. Approved by the EMA in 2009, with no evidence it extended life. Not available on the NHS. Previously available on the Cancer Drugs Fund but cut in 2015. Trials show it stops the progression of the disease for an average of three months.

The NHS, however, will not use them unless its watchdog NICE assesses them as showing value for money.

In many cases drugs approved by the EMA have been rejected by NICE, leading to years of back-and-forths and arguments about medical rationing.

Some of the drugs deemed by the researchers to have shown no benefit are now available to UK patients – but only after manufacturers vastly reduced their prices.

Others were provided on the Cancer Drugs Fund, a scheme set up by David Cameron in 2011 to provide access to medicines not approved by NICE.

That scheme came under severe criticism after it vastly overspent its budget, meaning many treatments were cut from the fund.

The researchers, whose work is published in the British Medical Journal, wrote: ‘When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded healthcare systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined.’

The team assessed 68 cancer treatments approved during the study period.

They found most drugs had not been assessed for long enough to provide any meaningful survival data, and instead were licensed on the basis of other factors such as whether tumours stopped growing.

Only 35 per cent of treatments yielded evidence that they prolonged life when they were first approved. Ten per cent showed they improved quality of life. But 57 per cent had no evidence of either.

Scientists stress it takes time to prove a drug will improve life expectancy. And patient groups insist when someone is dying with cancer, even a few extra months of life with loved ones is priceless.

Lead author Dr Courtney Davis of KCL said: ‘When expensive drugs that lack robust evidence of clinical benefit are approved and reimbursed within publicly funded healthcare systems, individual patients may be harmed and public funds wasted.’

A spokesman for the EMA said: ‘EMA has had no time yet to analyse the findings of the BMJ study properly.

‘What we can say is that EMA has discussed the evidence underpinning cancer medicines widely and welcomes further debate on this.’

The Government in April introduced rules allowing NHS England to restrict or delay treatments if the total cost exceeds £20million a year.

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