1 Recommendations

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

  • their tumours are PD-L1 positive, and

  • 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.

Why the committee made these recommendations

The treatment pathway for locally advanced or metastatic non-squamous NSCLC starts with a PD-1 or PD-L1 inhibitor or chemotherapy. Nivolumab would be used after chemotherapy.

Evidence collected in the Cancer Drugs Fund is for people with PD‑L1-positive disease having up to 2 years of nivolumab treatment in the NHS. The key clinical trial shows that people with PD‑L1-positive tumours 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 shows 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 an acceptable use of NHS resources. Therefore, it is now recommended in the NHS for people with PD‑L1-positive tumours who have not had a PD‑1 or PD‑L1 inhibitor before, when it is stopped at 2 years.

  • National Institute for Health and Care Excellence (NICE)