1.1 Nivolumab is recommended for use within the Cancer Drugs Fund as an option for treating squamous cell carcinoma of the head and neck in adults whose disease has progressed on platinum-based chemotherapy, only if:
the disease has progressed within 6 months of having chemotherapy
nivolumab is stopped at 2 years of uninterrupted treatment, or earlier in the event of disease progression and
the conditions in the managed access agreement are followed.
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
There are limited treatment options for squamous cell carcinoma of the head and neck that has progressed on platinum-based chemotherapy. The population in the clinical trial for nivolumab had disease that had progressed within 6 months of platinum-based chemotherapy (early recurrence). This is a clinically distinct population who have a poor prognosis and whose disease will not be retreated with a platinum drug. In England, these people are usually offered docetaxel.
Clinical trial evidence shows that nivolumab improves overall survival by 2.6 months compared with docetaxel, methotrexate or cetuximab, but longer-term survival benefit, after 2 years, is uncertain. There is also uncertainty about its benefit for tumours expressing less than 1% PD-L1 protein.
Nivolumab meets NICE's criteria to be considered a life-extending end-of-life treatment. However, it cannot be recommended for routine use because the most likely cost-effectiveness estimate would fall between £45,000 and £73,600 per quality-adjusted life year gained.
Nivolumab has the potential to be cost effective, but more evidence is needed to address the clinical uncertainties. It can therefore be recommended for use within the Cancer Drugs Fund while further data are collected as part of a managed access agreement. Collecting further data from people having nivolumab should address the uncertainties about its benefits for longer-term survival and for tumours expressing less than 1% PD-L1 protein.