1 Recommendations

1.1 Pembrolizumab is recommended as an option for treating tumours with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency in adults with:

  • advanced or recurrent endometrial cancer that has progressed during or after a platinum-based therapy, who cannot have curative surgery or radiotherapy

  • unresectable or metastatic gastric, small intestine or biliary cancer that has progressed during or after 1 therapy

  • colorectal cancer after fluoropyrimidine combination therapy, only if they cannot have nivolumab with ipilimumab.

    It is only recommended if:

  • pembrolizumab is stopped at 2¬†years of uninterrupted treatment, or earlier if the cancer progresses, and

  • the company provides it according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with pembrolizumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations 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

For previously treated endometrial, gastric, small intestine and biliary cancer with high MSI or MMR deficiency in adults, usual treatment at the time of the evaluation was chemotherapy. For people with previously treated colorectal cancer with high MSI or MMR deficiency, usual treatment is nivolumab with ipilimumab, or chemotherapy if they cannot have nivolumab with ipilimumab. Pembrolizumab would be offered as an alternative to chemotherapy for all of these indications.

Pembrolizumab has not been compared directly with chemotherapy in clinical trials. When compared indirectly, the results suggest that people having pembrolizumab live for longer and have longer before their cancer gets worse than people having chemotherapy, although these results are uncertain.

When considering the condition's severity, its effect on quality and length of life, and the uncertainty in the clinical evidence, the most likely cost-effectiveness estimates for pembrolizumab in all the types of cancer are within the range that NICE considers an acceptable use of NHS resources. So, it is recommended.