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New HTA Decisions in England
May 2019
Drug name
KEYTRUDA® (pembrolizumab)
Merck Sharp & Dohme
Decision date
Therapeutic area
Therapeutic sub area
Skin cancer
Recommended (CDF)
An option for the adjuvant treatment of stage III melanoma with lymph node involvement in adults who have had complete resection
Decision Detail
It is recommended only if the conditions in the managed access agreement for pembrolizumab are followed.
Clinical-effectiveness data for pembrolizumab compared with routine surveillance came from the ongoing KEYNOTE-054 study. Despite the need for long-term data, the committee could conclude that pembrolizumab improves recurrence-free survival compared with placebo. Notably, the clinical lead for the Cancer Drugs Fund pointed out that it is unusual for adjuvant therapies to show such a pronounced recurrence-free survival benefit this early in follow-up, and that the benefit of pembrolizumab as adjuvant treatment is clinically significant. The committee concluded that more evidence is needed to address clinical uncertainties but pembrolizumab does have the potential to be cost-effective. This would be well informed by further data showing the number of people developing distant metastases and overall survival. Pembrolizumab can therefore be recommended for use in the Cancer Drugs Fund for people who have stage III melanoma with lymph node involvement who have had complete resection.