The immunotherapy nivolumab will not be recommended for the treatment of patients with relapsed or metastatic head-and-neck cancer, under a new draft technology appraisal issued by NICE.
The drug was hailed as a potential ‘game changer’ for these patients after being found to greatly improve survival in a phase III clinical trial.
The trial was led in the UK by Professor Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust.
The results were published in the New England Journal of Medicine and received widespread media coverage in October last year.
But NICE judged that nivolumab should not be made available on the NHS for adults with relapsed or metastatic squamous cell head and cancer after concluding that it was not sufficiently cost-effective.
'Frustrating'
Commenting on the draft decision, Professor Harrington said: “It is disappointing and frustrating that today’s decision means doctors will not be able to offer this game-changing immunotherapy to patients with advanced head-and-neck cancer. Once it has relapsed or spread, the disease is extremely difficult to treat and options, including surgery and radiotherapy, are very limited.
“Nivolumab is an expensive drug but it is also the only treatment shown in a phase III trial to improve survival for this group of patients – and it did so without worsening patients’ quality of life, and with fewer side-effects than other options. It’s crucial that talks on the drug’s availability continue and ultimately that this decision is reversed, since otherwise patients face missing out on a genuinely effective treatment simply because of cost.”
Agreement urged
Professor Paul Workman, Chief Executive of the ICR, said: “This decision denies patients a genuine breakthrough treatment that makes a real difference for people with relapsed or metastatic head-and-neck cancer. It is another example, and a particularly stark one, of an innovative cancer therapy not being made available on the NHS because of cost. I’d urge NICE and the manufacturer to work together to reach an agreement on price so that this decision can be overturned as soon as possible.
“We need to recognise that the price of cancer drugs is much too high, and that’s particularly the case with the exciting new wave of immunotherapies. We need pharmaceutical companies to bring down the cost of drug development through smaller, more targeted trials, and to do much more to pass on the savings to patients.
"NICE for its part must take much greater account of innovation in its appraisal processes, to give exciting treatments like nivolumab a better chance of reaching patients.”
Relevant parties still have a chance to appeal, so the decision may yet be reversed.