1 Recommendation

1.1 Pembrolizumab is recommended as an option for untreated PD‑L1-positive metastatic non-small-cell lung cancer (NSCLC) in adults whose tumours express PD‑L1 (with at least a 50% tumour proportion score) and have no epidermal growth factor receptor- or anaplastic lymphoma kinase-positive mutations, only if:

  • pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier in the event of disease progression and

  • the company provides pembrolizumab according to the commercial access agreement.

Why the committee made this recommendation

People with untreated metastatic PD‑L1-positive NSCLC are usually offered platinum-based chemotherapy (docetaxel, gemcitabine, paclitaxel, vinorelbine or pemetrexed, with a platinum-based drug).

Clinical trial evidence shows that pembrolizumab increases the length of time people live by nearly 16 months compared with chemotherapy. Although there is uncertainty about the long-term treatment benefit of pembrolizumab after treatment is stopped, there was sufficient evidence of an important extension-to-life benefit in people with untreated stage 4 metastatic PD‑L1-positive NSCLC compared with standard care.

The most plausible cost-effectiveness estimate for pembrolizumab compared with chemotherapy is within the range NICE normally considers acceptable for an end-of-life treatment. Therefore it can be recommended as an option for untreated metastatic PD‑L1-positive (with at least a 50% tumour proportion score) NSCLC if treatment is stopped after 2 years.

  • National Institute for Health and Care Excellence (NICE)