References
Latimer N. NICE DSU Technical Support Document 14: Undertaking survival analysis for economic evaluations alongside clinical trials—extrapolation with patient-level data. Updated March 2013. Sheffield: University of Sheffield; 2011. https://www.sheffield.ac.uk/nice-dsu/tsds/survival-analysis.
Rutherford M, Lambert P, Sweeting M, Pennington R, Crowther M, Abrams K, Latimer N. NICE DSU technical support document 21: flexible methods for survival analysis [TSD21]: Decision Support Unit, ScHARR, University of Sheffield; 2020. http://www.nicedsu.org.uk.
National Institute for Health and Care Excellence (NICE). Nivolumab with chemotherapy for neoadjuvant treatment of resectable non-small-cell lung cancer [TA876]. London: National Institute for Health and Care Excellence (NICE); 2023. https://www.nice.org.uk/guidance/ta876.
Bristol Myers Squibb Pharmaceuticals Ltd. Nivolumab with chemotherapy for neoadjuvant treatment of resectable non-small cell lung cancer [ID3757]. Document B. Company evidence submission—original submission received on 23 September 2022. Bristol Myers Squibb Pharmaceuticals; 2022.
Filleron T, Bachelier M, Mazieres J, Pérol M, Meyer N, Martin E, et al. Assessment of treatment effects and long-term benefits in immune checkpoint inhibitor trials using the flexible parametric cure model: a systematic review. JAMA Netw Open. 2021;4(12):e2139573-e. https://doi.org/10.1001/jamanetworkopen.2021.39573.
Chaudhary MA, Edmondson-Jones M, Baio G, Mackay E, Penrod JR, Sharpe DJ, et al. Use of advanced flexible modeling approaches for survival extrapolation from early follow-up data in two nivolumab trials in advanced NSCLC with extended follow-up. Med Decis Mak. 2023;43(1):91–109. https://doi.org/10.1177/0272989x221132257.
Gordon J, McEwan P, Ward T, Penrod JR, Wagner S, Yuan Y. PRM6 - Defining and estimating the cure fraction bias in survival modelling of novel immuno-oncology therapy agents in small-cell lung cancer. Value Health. 2018;21:S211. https://doi.org/10.1016/j.jval.2018.04.1435.
Tappenden P, Chilcott J, Ward S, Eggington S, Hind D, Hummel S. Methodological issues in the economic analysis of cancer treatments. Eur J Cancer. 2006;42(17):2867–75. https://doi.org/10.1016/j.ejca.2006.08.010.
Ouwens MJNM, Mukhopadhyay P, Zhang Y, Huang M, Latimer N, Briggs A. Estimating lifetime benefits associated with immuno-oncology therapies: challenges and approaches for overall survival extrapolations. Pharmacoeconomics. 2019;37(9):1129–38. https://doi.org/10.1007/s40273-019-00806-4.
Bullement A, Latimer NR, Bell GH. Survival extrapolation in cancer immunotherapy: a validation-based case study. Value Health. 2019;22(3):276–83. https://doi.org/10.1016/j.jval.2018.10.007.
Lambert PC. Modeling of the cure fraction in survival studies. Stata J. 2007;7(3):351–75. https://doi.org/10.1177/1536867x0700700304.
Othus M, Bansal A, Koepl L, Wagner S, Ramsey S. Accounting for cured patients in cost-effectiveness analysis. Value Health. 2017;20(4):705–9. https://doi.org/10.1016/j.jval.2016.04.011.
Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, et al. Neoadjuvant nivolumab plus chemotherapy in resectable lung cancer. N Engl J Med. 2022;386(21):1973–85.
National Institute for Health and Care Excellence (NICE). Atezolizumab for adjuvant treatment of resected non-small-cell lung cancer. Technology appraisal guidance [TA823]. London: National Institute for Health and Care Excellence (NICE); 28 Sep 2022. https://www.nice.org.uk/guidance/ta823.
National Institute for Health and Care Excellence (NICE). Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection [TA761]. London: National Institute for Health and Care Excellence (NICE); 19 Jan 2022. https://www.nice.org.uk/guidance/ta761.
Ondhia U, Conter HJ, Owen S, Zhou A, Nam J, Singh S, et al. Cost-effectiveness of second-line atezolizumab in Canada for advanced non-small cell lung cancer (NSCLC). J Med Econ. 2019;22(7):625–37. https://doi.org/10.1080/13696998.2019.1590842.
National Institute for Health and Care Excellence (NICE). NICE health technology evaluations: the manual. Process and methods [PMG36]. London: National Institute for Health and Care Excellence (NICE); 31 Jan 2022. https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation.
National Institute for Health and Care Excellence (NICE). Nivolumab with chemotherapy for neoadjuvant treatment of resectable non-small-cell lung cancer [TA876]. Chapter 1 Recommendations. London: National Institute for Health and Care Excellence (NICE); 2023. https://www.nice.org.uk/guidance/ta876/chapter/1-Recommendations.
Kongnakorn T, Sarri G, Freitag A, Marczell K, Kazmierska P, Masters E, et al. Modeling challenges in cost-effectiveness analysis of first-line immuno-oncology therapies in non-small cell lung cancer: a systematic literature review. Pharmacoeconomics. 2022;40(2):183–201. https://doi.org/10.1007/s40273-021-01089-4.
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Ryan Kenny contributed to a technology briefing on this indication for the National Institute for Health and Care Research (NIHR) Innovation Observatory. Giovany Orozco-Leal, Eugenie Evelynne Johnson, Sedighe Hosseinijebeli, Tomos Robinson, Tara Homer, Claire H. Eastaugh, Catherine Richmond, Louise Tanner, Nick Meader, Sheila A Wallace, and Stephen Rice have no conflicts of interest to declare.
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The independent EAG report was commissioned by the NIHR Evidence Synthesis Programme as project number NIHR135664. See the Health Technology Assessment (HTA) programme website for further project information (https://www.nihr.ac.uk/explore-nihr/funding-programmes/health-technology-assessment.htm). This summary of the EAG report was compiled after NICE issued the Final Appraisal Determination. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of NICE or the Department of Health.
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All authors contributed to the study conception and design and were involved with the work of the EAG. The manuscript was written by GOL, EEJ, and SR. All authors were involved in the critical review of the clinical and cost-effectiveness evidence, drafting of the EAG report, and providing critical feedback on the manuscript. All authors approved the final version.
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Orozco-Leal, G., Johnson, E.E., Hosseinijebeli, S. et al. Considerations for the Cure Assumption in an NICE Single Technology Appraisal of Nivolumab with Chemotherapy for Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer: Evidence Assessment Group Perspective. PharmacoEconomics 42, 133–136 (2024). https://doi.org/10.1007/s40273-023-01328-w
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DOI: https://doi.org/10.1007/s40273-023-01328-w