OBJECTIVES: In June 2011 the National Institute for Health and Care Excellence (NICE) Decision Support Unit (DSU) published a technical support document (TSD) to provide recommendations on systematic processes for undertaking survival analysis for NICE technology appraisals (TAs). Survival analysis outputs are often the most influential inputs into economic models estimating the cost-effectiveness of new cancer treatments. Hence, it is important that systematic and justifiable model selection approaches are used. This study investigates the extent to which the TSD recommendations have been followed since the publication of the TSD.

METHODS: We reviewed NICE cancer TAs completed between July 2011 and July 2017. Information on survival analyses undertaken and associated critiques for overall survival (OS) and progression-free survival were extracted from the company submissions, evidence review group (ERG) reports and final appraisal determination documents.

RESULTS: Information was extracted from 62 TAs. Only two (3%) followed all TSD process recommendations for OS outcomes. The vast majority (89%) compared a range of standard parametric models and assessed their fit to the data (85%). Only a minority of TAs included an assessment of the shape of the hazard function (39%) or proportional hazards assumption (42%). In addition, validation of the extrapolated portion of the survival function using external data was attempted in a minority of TAs (31%). Extrapolated survival functions were frequently criticised by ERGs (71%). Some analytical methods were used which were not considered within the TSD.

CONCLUSIONS: Survival analysis within NICE TAs remains sub-optimal, despite publication of the TSD. Model selection is not undertaken in a systematic way resulting in inconsistencies between TAs. More attention needs to be given to assessing hazard functions and the validation of extrapolated survival functions. Novel methods have been used, particularly in the context of immuno-oncology, suggesting that a new or updated TSD may be of value.