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1 Recommendations

1.1

Zolbetuximab with fluoropyrimidine- and platinum-based chemotherapy is not recommended, within its anticipated marketing authorisation, for untreated locally advanced, unresectable or metastatic claudin 18.2-positive, HER2-negative, gastric or gastro-oesophageal junction adenocarcinoma in adults.

1.2

This recommendation is not intended to affect treatment with zolbetuximab with fluoropyrimidine- and platinum-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 healthcare professional consider it appropriate to stop.

Why the committee made these recommendations

Standard care for gastric or gastro-oesophageal junction adenocarcinoma includes chemotherapy by itself, or with nivolumab or pembrolizumab. Zolbetuximab with fluoropyrimidine- and platinum-based chemotherapy (from now, zolbetuximab with chemotherapy) is a treatment option for people whose cancer expresses a protein called claudin 18.2.

Evidence suggests that people who have zolbetuximab and chemotherapy have longer before their cancer gets worse and live longer than people who have placebo and chemotherapy. Zolbetuximab plus chemotherapy has been indirectly compared with pembrolizumab plus chemotherapy and nivolumab plus chemotherapy. The results found no differences in effectiveness between zolbetuximab and the other 2 treatments.

There are uncertainties in the economic model used to estimate the cost effectiveness of zolbetuximab. These include:

  • the long-term survival estimates

  • how the efficacy of each treatment was estimated, and the data used to do this.

Even when considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates for zolbetuximab plus chemotherapy compared with chemotherapy alone are above what NICE considers an acceptable use of NHS resources. Analysis of the economic model shows that zolbetuximab plus chemotherapy is not cost effective compared with nivolumab or pembrolizumab plus chemotherapy. So, it is not recommended.