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Cancer experts condemn cancer drug decision

NICE drops recommended use of cancer drug nivolumab

Adrian O'Dowd

Tuesday, 11 April 2017

Expert cancer clinicians have condemned a preliminary decision by the National Institute for Health and Care Excellence (NICE) not to approve use of the drug nivolumab (Opdivo) for the treatment of head and neck cancer on the NHS.

NICE has today issued new draft guidance which does not recommend nivolumab in this way, saying that it is not cost-effective.

Nivolumab is administered intravenously every two weeks and the drug works by blocking a protein on the surface of cells known as PD-L1, which reduces the activity of the body’s immune cells. There is more PD-L1 on cancerous cells which stops the immune system from attacking the tumour.

NICE said the anticipated marketing authorisation for nivolumab was for treating squamous cell carcinoma of the head and neck which has progressed during or after platinum-based chemotherapy.

The watchdog found that the evidence showed a significant improvement in overall survival rates in the short term after nivolumab. However, its value for money was considerably above that which is usually a cost-effective use of NHS resources.

The draft guidance also says that that people already receiving the drug may continue until they or their doctor think it is appropriate to stop.

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.”

There are around 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 around 600 patients would be eligible for this treatment.

NICE said the manufacturer, healthcare professionals and members of the public were now able to comment on the draft recommendations via the NICE website until 4 May before it issued final guidance.

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, was unhappy at the decision.

“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,” said Professor Harrington.

“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.”

Professor Paul Workman, chief executive of The Institute of Cancer Research, said: “This decision denies patients a genuine breakthrough treatment that makes a real difference for people with relapsed of 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.”

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