You must be signed in to answer questions

  • Question on Consultation

    Has all of the relevant evidence been taken into account?
  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?
  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?

1 Recommendations

1.1 Nivolumab is not recommended, within its marketing authorisation, for treating recurrent or metastatic squamous cell carcinoma of the head and neck in adults whose disease has progressed during or after platinum-based chemotherapy.

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 of 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

This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for nivolumab for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy (NICE technology appraisal guidance 490). If nivolumab is not recommended for routine commissioning in this indication when final guidance is published, it will no longer be available in the Cancer Drugs Fund for people to start treatment, but people already taking it will be able to continue.

The new evidence includes data from clinical trials and from patients having treatment in the NHS, while this treatment was available in the Cancer Drugs Fund in England. It shows that people who have nivolumab are likely to live up to 9 months longer than those who have docetaxel, methotrexate or cetuximab. But it is unclear whether nivolumab extends life for longer than 3 months in people who are fit enough to be offered docetaxel or for people with tumours with a low PD-L1 score. These groups of people are most likely to be offered nivolumab in the NHS. So it is unclear whether nivolumab meets NICE's criteria to be considered a life-extending treatment.

The cost-effectiveness estimates are highly uncertain. But they are likely to be at the higher end of what NICE considers an acceptable use of NHS resources, and could exceed the maximum. So nivolumab is not recommended.