Saving Lives through Early Access: Exploring the Impact of a Managed Access Agreement in Adjuvant EGFRm NSCLC
Author(s)
Verhoek A1, Rutherford M2, Wise S3, Miller P4, Dunlop W5
1Cytel, Rotterdam, ZH, Netherlands, 2Cytel Inc., London, UK, 3AstraZeneca UK, London, London, City of, UK, 4Miller Economics Ltd, Macclesfield, UK, 5AstraZeneca, Cambridge, CAM, Great Britain
Presentation Documents
OBJECTIVES: Adjuvant osimertinib in resected stage IB‒IIIA epidermal growth factor receptor mutation-positive (EGFRm) non-small-cell lung cancer (NSCLC) improved survival versus placebo in the phase III ADAURA study. The appraisal by the UK’s National Institute for Health and Care Excellence (NICE) based on an early data readout, with encouraging DFS data, (January 2020 data cut-off (DCO)) led to its recommendation for the Cancer Drugs Fund (CDF) in Nov 2021. Overall survival (OS) data were immature (4%) at the time of recommendation. The January 2023 DCO for OS had an 18.2% maturity (hazard ratio 0.49 [0.34-0.70]).
The objective is to estimate the number of early deaths prevented by the inclusion of osimertinib into the UK CDF, after regulatory approval, with the ADAURA indication, focusing on the 3-year period between the first DFS DCO and the OS DCO.METHODS: The number of early deaths prevented was estimated using the ADAURA OS 2023 data and is based on 279 new patients in year 1 and 558 new patients/year for year 2 and 3, as estimated by the NICE Resource Impact Assessment team. An incidence-based approach was used to estimate patient flow over a 3-year period, based on a previous lives lost approach in early-stage NSCLC.
RESULTS: Over a 3-year period, there were 1395 new patients eligible for osimertinib. The analysis showed that over this period, 74 deaths may have been avoided due to early adoption of osimertinib through the CDF. This equated to 3, 21, 50 lives saved in years 1 to 3, respectively.
CONCLUSIONS: These findings highlight the benefit of managed access for adjuvant osimertinib before data maturity of all endpoints is reached. Given that only the incremental survival difference in the first years is used, this is a conservative analysis with opportunities to explore modelling approaches that adopt a lifetime perspective.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
EE204
Topic
Economic Evaluation, Health Technology Assessment, Methodological & Statistical Research
Topic Subcategory
Decision & Deliberative Processes, Novel & Social Elements of Value, Trial-Based Economic Evaluation
Disease
Oncology