1 Recommendations

1 Recommendations

1.1 Pembrolizumab with carboplatin and paclitaxel is recommended as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, only if

  • their tumours express PD‑L1 with a tumour proportion score of 0% to 49%

  • their tumours express PD‑L1 with a tumour proportion score of 50% or more and they need urgent clinical intervention

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

  • the company provides pembrolizumab according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with pembrolizumab plus carboplatin and paclitaxel that was started in the Cancer Drugs Fund before this guidance was published. For those people, pembrolizumab plus carboplatin and paclitaxel will be funded by the company until the patient 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 pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous NSCLC.

Initial treatment for metastatic squamous NSCLC depends on PD‑L1 tumour proportion score. People whose tumours have a PD‑L1 tumour proportion score of 0% to 49%, usually have cisplatin or carboplatin plus either gemcitabine, paclitaxel or vinorelbine (platinum-based combination chemotherapy). People whose tumours have a PD‑L1 tumour proportion score of 50% or more usually have pembrolizumab alone.

Clinical trial evidence shows that pembrolizumab plus carboplatin and paclitaxel or nab-paclitaxel (pembrolizumab combination therapy) increases how long people with metastatic squamous NSCLC live compared with placebo plus carboplatin and paclitaxel or nab-paclitaxel.

Pembrolizumab combination therapy meets NICE's criteria to be considered a life-extending treatment at the end of life in both PD‑L1 tumour proportion score subgroups. The cost-effectiveness estimates in people whose tumours express PD‑L1 with a tumour proportion score of 0% to 49% were within what NICE considers a good use of NHS resources. For people whose tumours have a PD‑L1 tumour proportion score of 50% or more and who need an urgent clinical intervention (for example, because their cancer may cause major airway blockage), the cost-effectiveness estimates were not certain. However, they are likely to be within what NICE considers a good use of NHS resources, so pembrolizumab combination is recommended in both groups.

  • National Institute for Health and Care Excellence (NICE)