An Increased Use of External Data to Inform Survival Extrapolations in NICE Technology Appraisals
Author(s)
Reitsma F1, Pham HA1, van Beekhuizen S2
1Ingress-Health Nederland B.V., Rotterdam, Netherlands, 2Cytel, Rotterdam, Netherlands
Presentation Documents
OBJECTIVES: Since the relaunch of the Cancer Drugs Fund in 2016, the number of technology appraisals (TAs) in oncology has increased, reaching an all-time high in 2021-2022 (50 TAs). In 2020, the National Institute for Health and Care Excellence (NICE) released its technical support document on the use of external data to inform the extrapolations of immature survival (TSD21). The objective was to investigate the frequency, methods, and acceptance of using external data to quantitatively inform survival extrapolation in oncology TAs since the release of TSD21.
METHODS: All oncology TAs from NICE were screened. Terminated TAs were excluded. Eligible TAs were considered for full-text review when external data was used to quantitatively inform survival extrapolation. Full-text review included an assessment of the submission and ERG report.
RESULTS: A total of 494 TAs were extracted from the NICE database, of which 109 were published since TSD21. Due to termination, 22 of TAs since TSD21 were excluded. Since TSD21, 28/87 (32.2%) of TAs used external data, compared to 15/134 (11.2%) of TAs published from May 2016 to November 2020. The rate of positive recommendations among included TAs using external data (25/28 [89.3%]) was similar to TAs not using external data (53/59 [89.8%]). Registry data and historical trial data were used most frequently (16 TAs), mostly to inform individual health state transition probabilities or survival extrapolations for external control-arms. ERG critique focused on data transparency, reliability and generalisability, data immaturity, and the introduction of bias.
CONCLUSIONS: There has been an increase in the use of external data sources to inform survival extrapolation after TSD21. While there are more factors potentially impacting final NICE recommendation in a TA, the rate of positive recommendations for TAs using external data was similar to those that were not. The impact of external data use on the final NICE recommendation remains unclear.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
HTA89
Disease
Drugs, Oncology