Cost regulators have ruled that Bristol-Myers Squibb’s immunotherapy Opdivo is too expensive for NHS use to treat head and neck cancer despite the offer of Patient Access Scheme to increase the drug’s cost-effectiveness.

The National Institute for Health and Care Excellence has now published new draft guidance rejecting the drug for treating squamous cell carcinoma of the head and neck which has progressed during or after platinum-based chemotherapy.

While the Committee found that the evidence showed a significant improvement in overall survival rates in the short term after treatment with Opdivo (nivolumab), it concluded that its value for money “was considerably above” that which is usually considered to be a cost-effective use of NHS resources.

NICE calculated the drug’s incremental cost effectiveness ratios (ICERs) would be above the range of £66,000 to £75,000 per QALY gained compared to other treatments, and thus far above the normal £20,000 to £30,000 per QALY value for money threshold or £50,000 bar for life-extending therapies.

“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,” said Professor Carole Longson, director of the health technology evaluation centre at NICE.

“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.”

There are just under 10,000 cases of head and neck cancer each year in the UK and survival rates after the disease has progressed with chemotherapy is around six months. It is estimated that up to 600 patients would be eligible for this treatment.

“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,” said 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, who led the UK arm of the phase III clinical trial of nivolumab for advanced head and neck cancer.

“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.”

“This decision denies patients a genuine breakthrough treatment that makes a real difference for people with relapsed of metastatic head and neck cancer,” added Professor Paul Workman, chief executive of The ICR.

“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."

The drug has not yet been issued a green light to treat head and neck cancer by the European Commission but has won backing from the European Medicines Agency Committee for Medicinal Products for Human Use, based on data from the Phase III CheckMate -141 trial.

This showed that Opdivo nearly doubled patients’ one-year overall survival from 17 percent in the chemotherapy arm to 36 percent in the group receiving treatment with the drug.