A hi-tech immunotherapy drug is too costly to be given to NHS patients with deadly head and neck cancers despite trial evidence it can extend their lives, the healthcare rationing watchdog has ruled.
The decision by the National Institute for Health and Care Excellence (Nice) was described as "disappointing and frustrating" by one British cancer expert who co-led the study.
In draft guidance, Nice said it could not recommend nivolumab for the routine treatment of NHS patients in England with advanced head and neck cancer.
The high cost of the antibody drug, which prevents cancer hiding from the immune system, was said to outweigh its benefits.
Treating a single patient with nivolumab costs around £5,700 per month.
Last month Nice said more evidence of effectiveness was needed before it could recommend nivolumab for NHS patients with the blood cancer Hodgkin lymphoma.
The drug is already approved for treating melanoma skin cancer on the NHS and Nice is reconsidering a previous ruling denying lung cancer patients access to the drug.
Professor Kevin Harrington, from the Institute of Cancer Research, London, who led the UK arm of a Phase III trial looking at treating head and neck cancers with nivolumab, 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."
The trial involved 361 patients who were either treated with nivolumab or one of three different types of chemotherapy.
After one year, 36% of the nivolumab group were still alive compared with 17% of the chemotherapy group.
Professor Carole Longson, director of the health technology evaluation centre at Nice, said: "The committee heard that treatment options for patients in this area are limited, and it's important to patients that treatment extends their life and improves the quality of life.
"But the additional costs of nivolumab were considered to be very high in relation to its benefit to be recommended for routine NHS use at present."
Each year around 10,000 people in the UK are diagnosed with a head and neck cancer
Benjamin Hickey, UK and Ireland general manager at the pharmaceutical company Bristol-Myers Squibb, which markets nivolumab, said: "Advanced head and neck cancer has a very poor prognosis and new therapies are urgently needed to help prolong survival.
"Today's decision is deeply concerning and we have grave concerns that if Nice does not recognise the value of this breakthrough medicine for head and neck cancer and lung cancer patients, it could set a precedent for access to other innovative medicines in the future.
"It is vital that we find a solution that is fair for all and we ask Nice to share our sense of urgency on this matter."
Chris Curtis, chairman of The Swallows Head and Neck Cancer Support Group, said the cancers were "physically and emotionally devastating" and could lead to disfigurement and an impaired ability to breathe, speak or swallow.
He added: "For people with advanced disease, extending survival without further compromising the quality of life for patients is vital.
"We hope that Nice reconsiders the evidence and allows head and neck cancer patients to access this important medicine in its final recommendation and help patients enjoy a quality of life they deserve."