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New HTA Decisions in England
September 2020
Drug name
KEYTRUDA® (pembrolizumab)
Merck Sharp & Dohme
Decision date
Therapeutic area
Therapeutic sub area
Renal cancer
Not recommended
Pembrolizumab with axitinib is not recommended, within its marketing authorisation, for untreated advanced renal cell carcinoma in adults.
Decision Detail
The companies have commercial arrangements for each of the drugs. This makes pembrolizumab with axitinib available to the NHS with a discount and it would have also applied to this indication if the technology had been recommended. The size of the discount is commercial in confidence.
Based on evidence from KEYNOTE 426, an open-label, randomised phase 3 trial that compared pembrolizumab plus axitinib with sunitinib, the committee concluded that pembrolizumab with axitinib was more effective than sunitinib for overall survival and progression-free survival in untreated renal cell carcinoma, but the data are immature. Cost-effectiveness estimates are therefore uncertain (results are commercial in confidence). Pembrolizumab with axitinib is not suitable for use in the Cancer Drugs Fund because it is unlikely to be cost effective at its current price (even if the uncertainty about its effectiveness is reduced). Pembrolizumab with axitinib did not meet the criteria to be considered as a life-extending treatment at the end of life. Therefore, pembrolizumab with axitinib is not recommended.