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New HTA Decisions in England
March 2021
Drug name
KEYTRUDA® (pembrolizumab)
Merck Sharp & Dohme
Decision date
Therapeutic area
Therapeutic sub area
Lung cancer
Recommended with restrictions
Pembrolizumab with pemetrexed and platinum chemotherapy is recommended as an option for untreated, metastatic, non-squamous non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR)‑positive or anaplastic lymphoma kinase (ALK)‑positive mutations.
Decision Detail
This is only if: • it is stopped at 2 years of uninterrupted treatment, or earlier if the disease progresses and; • the company provides pembrolizumab according to the commercial arrangement (there is a commercial access agreement for pembrolizumab).
This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for pembrolizumab with pemetrexed and platinum chemotherapy (pembrolizumab combination) for untreated, metastatic, non squamous NSCLC (NICE technology appraisal guidance 557). Additional data from the KEYNOTE-189 randomised controlled phase 3 trial showed that pembrolizumab combination was associated with a statistically significant improvement in overall survival compared with pemetrexed platinum chemotherapy. There are no clinical trials directly comparing pembrolizumab combination with pembrolizumab monotherapy, but an indirect comparison suggests that for people with PD L1 positive tumours with a tumour proportion score of at least 50%, there is no difference in how long people having pembrolizumab combination live compared with pembrolizumab monotherapy. Pembrolizumab combination meets NICE's criteria to be considered a life-extending end of life treatment compared with pemetrexed platinum chemotherapy but does not meet the criteria when compared with pembrolizumab monotherapy. The cost-effectiveness estimates for pembrolizumab combination are within what NICE considers to be an acceptable use of NHS resources, if it is stopped at 2 years. So, it is recommended.