Presentation (CTI)

OBJECTIVES: In September 2022, NICE recommended adjuvant atezolizumab for non-small cell lung cancer (NSCLC) via the Cancer Drugs Fund (CDF) and entered a Managed Access Agreement (MAA) with the manufacturer and NHSE to provide early patient access while collecting further data. After the data collection concluded in August 2024 and was re-appraised, NICE fast-tracked and recommended atezolizumab for NSCLC in June 2025.
The objective was to critically review both appraisals (2022 and 2025) and evaluate the impact the CDF had on the appraisal and access.
METHODS: This critical review included the committee papers from the 2022 appraisal (TA823), the 2025 appraisal (ID6324) and the MAA. A focus was on the IMpower010 trial data, which was the primary data source of the MAA and was used in the reappraisal to address key uncertainties. The review identified shifts in evidence maturity and adjustments to key parameters.
RESULTS: The 2022 appraisal highlighted immature IMpower010 OS and DFS data in the PD-L1 ≥ 50% TC Stage II-IIIA population, with a 34-month follow-up, noting uncertainties in cure assumptions, DFS modeling, and treatment effect duration. The company’s DFS base case used log-logistic extrapolations and counter-intuitive "treatment waning" adjustments. Updated January 2024 data provided a 65-month follow-up, confirming consistent DFS benefits in the PD-L1 ≥ 50% subgroup. Final 2025 DFS extrapolations used Gompertz for atezolizumab and log-logistic/log-normal for active monitoring. Cure and treatment waning assumptions were refined, addressing uncertainties from the 2022 appraisal and improving model robustness.
CONCLUSIONS: The January 2024 IMpower010 data cut increased confidence in selection of parametric models, reducing significant uncertainty in the modeling. Combined with revised cure and treatment waning assumptions, ID6324 was recommended for routine commissioning, highlighting the positive impact of the CDF in providing patients with access to innovative medicines.