1 Recommendations

1 Recommendations

1.1 Nivolumab is recommended as an option for treating locally advanced or metastatic squamous non-small-cell lung cancer (NSCLC) in adults after chemotherapy, only if:

  • it is stopped at 2 years of uninterrupted treatment, or earlier if their disease progresses and

  • they have not had a PD‑1 or PD‑L1 inhibitor before.

    It is recommended only if the company provides nivolumab according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with nivolumab that was started in the Cancer Drugs Fund before final guidance was published. For those people, nivolumab will be funded by the company until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

The treatment pathway for locally advanced or metastatic squamous NSCLC starts with a PD-1 or PD-L1 inhibitor or chemotherapy. Nivolumab would be used after chemotherapy. In line with clinical practice, nivolumab is a treatment option for people who have not had a PD‑1 or PD‑L1 inhibitor.

Evidence was collected in the Cancer Drugs Fund for people with advanced or metastatic squamous NSCLC having up to 2 years of nivolumab treatment in the NHS. The key clinical trial shows that people who have nivolumab live longer than those who have docetaxel, which is the most appropriate comparator. There is uncertainty about how long people should have nivolumab for, but evidence suggests that there is continued benefit when treatment is stopped at 2 years.

Nivolumab meets NICE's criteria to be considered a life-extending treatment at the end of life. The cost-effectiveness estimates for nivolumab compared with docetaxel are likely to be within what NICE considers to be an acceptable use of NHS resources. Therefore, it is now recommended in the NHS after chemotherapy for people who have not had a PD‑1 or PD‑L1 inhibitor before, if it is stopped at 2 years.

  • National Institute for Health and Care Excellence (NICE)