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New HTA Decisions in England
October 2021
Drug name
KEYTRUDA® (pembrolizumab)
Company
MSD
Decision date
17/09/2021
Therapeutic area
Cancer
Therapeutic sub area
Oesophageal cancer
Decision
Recommended
Indication
Pembrolizumab with platinum- and fluoropyrimidine-based chemotherapy is recommended for untreated locally advanced unresectable or metastatic carcinoma of the oesophagus or HER2‑negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 10 or more.
Decision Detail
It is only recommended if the company provides it according to the commercial arrangement (simple discount patient access scheme).
Summary
Clinical evidence for pembrolizumab comes from KEYNOTE 590 which is a randomised, double-blind, placebo-controlled trial (n=749) comparing cisplatin and fluorouracil, with or without pembrolizumab, as first-line treatment for locally advanced unresectable or metastatic oesophageal adenocarcinoma, squamous cell carcinoma or advanced gastro-oesophageal junction adenocarcinoma. The marketing authorisation restricts pembrolizumab to a subgroup whose tumours are PD L1 positive with a CPS of 10 or more. Median progression-free survival in KEYNOTE 590 for people with a tumour with a CPS of 10 or more was 7.5 months in the pembrolizumab plus chemotherapy arm and 5.5 months in the placebo plus chemotherapy arm. The corresponding median overall survival for the pembrolizumab plus chemotherapy arm was 13.5 months and 9.4 months in the placebo plus chemotherapy arm. Therefore, the clinical trial evidence shows that for people whose tumours express PD L1 with a CPS of 10 or more, adding pembrolizumab improves overall survival and progression-free survival. Pembrolizumab meets NICE's criteria to be considered a life-extending treatment at the end of life. Both the company's and the ERG's cost-effectiveness estimates (ICERs) are below £50,000 per quality-adjusted life year gained. The exact ICERs cannot be reported here because of confidential commercial arrangements for pembrolizumab and subsequent treatments. However, the committee concluded that it was likely that pembrolizumab with platinum- and fluoropyrimidine-based chemotherapy is likely to be a cost-effective use of NHS resources. Therefore, pembrolizumab in combination with platinum- and fluoropyrimidine-based chemotherapy is recommended for use in the NHS as an option for treating locally advanced unresectable or metastatic carcinoma of the oesophagus or HER2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD L1 with a CPS of 10 or more.