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Lung cancer drug delay slammed as nivolumab is pulled from early access scheme

A delay in access to a game-changing immunotherapy drug that has been shown to double the life expectancy of some patients with lung cancer has been described as a "disgrace".

Paula Chadwick, chief executive of Roy Castle Lung Cancer Foundation, said patients are unlikely to be able to take nivolumab until May 2016 at the earliest, which will be too late for some.

Although the drug is officially licensed by the European Commission from today, it will have to go through the NHS approval system before it is available for patients and its cost-effectiveness has not yet been evaluated.

It had previously been available on the Early Access to Medicines scheme, which gives patients access to promising new drugs that are not yet licensed. But now that access will stop, a situation described as a "shambles" by Ms Chadwick.

Nivolumab is one of a new generation of immunotherapy drugs that help patients' own immune systems fight cancer.

In June, the results from a major international trial were described by one expert as a ''paradigm shift in the treatment of lung cancer''.

Researchers compared the effectiveness of nivolumab and the standard chemotherapy drug docetaxel in 582 patients with advanced non-squamous non-small cell lung cancer.

The disease accounts for around 85% of all cases of lung cancer, which is diagnosed in 44,000 new patients and causes 35,000 deaths each year in the UK.

Overall, nivolumab reduced the risk of dying by 27% compared with docetaxel and increased typical survival time from 9.4 to 12.2 months.

Ms Chadwick said: "This is a significant development for this very specific group of people with lung cancer and offers hope where there was very little before.

"But although there is a really positive story here, there is also a mess that needs to be sorted out. The pharmaceutical companies want their price and the NHS had its processes, but it's the patients here who are getting caught in the crossfire.

"To have a drug arrive that can make a significant difference and actually lengthen patients' life expectancy, but them to not have access to it is a disgrace.

"These patients don't have time to waste. We should hang our heads in shame."

Ms Chadwick said part of the problem lies in the Cancer Drugs Fund, which enables patients to access drugs that would not otherwise have been routinely available from the NHS, "being put on hold" along with politicians being on recess so no progress can be made.

NHS England national medical director Sir Bruce Keogh said: "It's right that independent medical experts at Nice should properly review whether new drugs are appropriate and whether drug companies are pricing them fairly.

"We want to speed up that process and are bringing together patient charities, Nice, the pharmaceutical industry, the medicines regulator and the Department of Health to develop a speedy system to get the most promising drugs to NHS patients as quickly as possible."


From Belfast Telegraph