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1 Recommendations

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1 Recommendations

1.1 Nivolumab is not recommended, within its anticipated marketing authorisation, for treating unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma in adults after fluoropyrimidine and platinum-based therapy.

1.2 This recommendation is not intended to affect treatment with nivolumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma is usually first treated with fluoropyrimidine and platinum-based therapy. Then if the cancer progresses, it is treated with a taxane (docetaxel or paclitaxel).

Clinical trial evidence suggests nivolumab does not improve how well the disease responds or how long people live without their disease progressing compared with taxane treatment. In the trial, the rate of death in the first 3 months of treatment was higher with nivolumab than with taxanes, even though the trial excluded people with a life expectancy of less than 3 months. After that, evidence suggests people live for longer with nivolumab compared with taxane treatment, but clear evidence of long-term survival after 3 months is needed.

Because of the uncertainty in the clinical evidence, there is substantial uncertainty about the most appropriate estimates for costs associated with nivolumab. New data based on further follow up from the trial (up to 36 months) has just become available to the company, but the effect on cost-effectiveness estimates is unknown.

Nivolumab meets NICE's criteria to be considered a life-extending treatment at the end of life. However, the most likely cost-effectiveness estimates are above what NICE normally considers an acceptable use of NHS resources. So, nivolumab is not recommended for routine use.

Nivolumab is not recommended for use within the Cancer Drugs Fund because it is unlikely to be cost effective at its current price (even if the uncertainty about its effectiveness is reduced).