Several cancer drugs have received catalyzed approval from the US FDA based on recently conducted clinical trials. The National Institute of Health and Care Excellence (NICE) conducted an independent study to evaluate the safety and efficacy of these FDA-approved drugs. This study aims to compare FDA approval decisions with NICE coverage decisions.
This retrospective cohort study included a total of 93 drug indications that received FDA approval, of which six were withdrawn, and 87 were taken forward for the study. Data obtained from NICE was used to determine coverage recommendations. The primary outcome of the study was the cancer drug indication coverage decision by NICE.
The European Medicines Agency (EMA) rejected five indications, and NICE rejected another seven of them. In addition, 12 drug recommendations were not recommended for public coverage, and 30 were not reviewed by either NICE or EMA. NICE recommended most drugs based on the negation of additional confidential discounts, collection of additional data, or the imposition of restricted indications. A total of nine drug indications had evidence of overall survival benefit, of which two were denied based on the cost-effectiveness criterion.
The research concluded that NICE and EMA denied 30 cancer drugs that had received accelerated approval by FDA.