The National Institute for Health and Care Excellence (NICE) in the United Kingdom has rejected MSD's Keytruda to treat advanced bladder cancer in a second final assessment paper.
Keytruda was first approved by NICE's Cancer Drugs Fund in 2018 for patients with metastatic or advanced urothelial carcinoma who had previously undergone platinum-based chemotherapy.
“The NICE has rejected MSD's Keytruda to treat advanced bladder cancer.“
Further evidence was collected for Keytruda as part of the managed access agreement, which NICE reviewed as part of its final decision. After findings from the KEYNOTE-045 trial showed a benefit for overall survival but not progression-free survival in the second-line environment, NICE agreed not to issue a permanent recommendation for Keytruda in this patient population in March 2020.
Managing Director, MSD, David Peacock, stated: “Following the initial decision by the NICE committee not to recommend the use of pembrolizumab in this setting, we have done what we can to ensure continued access for patients. Following our successful appeal of the original decision, MSD was able to bring fresh data analyses and make a further offer on the patient access scheme to address the committee’s concerns. We feel strongly that the appeal was the right decision and that patient access to this medicine should have been maintained. MSD remains committed to research in bladder cancer, where unmet need endures and we hope we can make meaningful positive impact through our science in the years ahead.”