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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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Draft guidance consultation

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1 Recommendations

1.1

Pembrolizumab with platinum- and fluoropyrimidine-based chemotherapy is not recommended, within its marketing authorisation, for untreated HER2‑negative locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 1 or more.

1.2

This recommendation is not intended to affect treatment with pembrolizumab with platinum- and fluoropyrimidine-based chemotherapy that was started in the NHS before this guidance was published. People having treatment outside 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

Usual treatment for HER2-negative locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma that express PD‑L1 with a CPS of 1 or more is platinum- and fluoropyrimidine-based chemotherapy (doublet chemotherapy). Treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma that expresses PD‑L1 with a CPS of 5 or more is nivolumab plus doublet chemotherapy.

Clinical trial evidence shows that pembrolizumab plus doublet chemotherapy increases how long people live and how long they have before their condition gets worse compared with placebo plus doublet chemotherapy, in people whose tumours express PD‑L1 with a CPS of 1 or more.

Pembrolizumab plus doublet chemotherapy has not been directly compared in a clinical trial with nivolumab plus doublet chemotherapy. An indirect comparison suggests that it is likely to work as well as nivolumab for people whose tumours express PD‑L1 with a CPS of 5 or more.

Even when considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates for pembrolizumab plus doublet chemotherapy compared with doublet chemotherapy alone are above the range that NICE considers an acceptable use of NHS resources. The cost-effectiveness estimates compared with nivolumab plus doublet chemotherapy are also above the range. So, pembrolizumab plus doublet chemotherapy is not recommended.