Journal Article

Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World

Pasello, Giulia, Pilotto, Sara, Targato, Giada, Ferro, Alessandra, Lorenzi, Martina, Polo, Valentina, Da Ros, Valentina, Santarpia, Mariacarmela, Bonanno, Laura, Frega, Stefano, Pavan, Alberto, Cumerlato, Enrico, Bortolami, Alberto, Guarneri, Valentina, Scattolin, Daniela, Dal Maso, Alessandro, Cecere, Fabiana, Macerelli, Marianna, Del Conte, Alessandro

2024

Overview

Abstract Introduction The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients. Methods Herein, we report updated survival data, post-progression management, cost/effectiveness and budget impact (BI) of osimertinib compared with a RW population receiving gefitinib or erlotinib. Results Overall, 189 Caucasian patients receiving first-line osimertinib were included. After a follow-up of 20.7 months, 74(39.2%) patients discontinued osimertinib, median time-to-treatment discontinuation (mTTD) was 27.9 months, overall survival 36.8 months. At progression, tissue biopsy was performed in 29 (56.9%), liquid biopsy in 15 (29.4%) and both in 7 (13.7%) cases. The most frequent resistant mechanism was MET amplification (N = 14, 29.8%). At data cutoff, 13 (6.9%) patients were continuing osimertinib beyond progression; 52 (67.5%) received second-line treatment; no further treatments were administered in 25 (32.5%) cases. Thirty-three (63.4%) patients received chemotherapy, 12(23.1%) TKIs combination. Cost–effectiveness analysis showed a total cost per patient based on RW mTTD of 98,957.34€, 21,726.28€ and 19,637.83€ for osimertinib, erlotinib and gefitinib, respectively. The incremental cost-effectiveness ratio (ICER)/month for osimertinib was 359,806.0€/life-year-gained (LYG) and 197,789.77€/LYG compared to erlotinib and gefitinib. For osimertinib, the BI-gap between RW-TTD and theoretical-TTD was 16,501.0€ per patient. Conclusions This updated analysis confirms the effectiveness of osimertinib in RW. Although the ICER of osimertinib seems not cost-effective, additional costs for the management of disease progression to old generation TKIs were not considered in this study. The BI-gap suggests RW mTTD as a more reliable measure for expense estimation. This article reports updated survival data, post-progression diagnostic-therapeutic pathway, cost-effectiveness, and budget impact of osimertinib in patients treated with first-line osimertinib and included in the FLOWER study.

• Publisher: Oxford University Press
• Subject: Acrylamides - economics / Acrylamides - pharmacology / Acrylamides - therapeutic use / Adult / Aged / Aged, 80 and over / Aniline Compounds - economics / Aniline Compounds - therapeutic use / Antineoplastic Agents - economics / Antineoplastic Agents - therapeutic use / Biopsy / Budget / Cancer / Carcinoma, Non-Small-Cell Lung - drug therapy / Carcinoma, Non-Small-Cell Lung - economics / Carcinoma, Non-Small-Cell Lung - genetics / Carcinoma, Non-Small-Cell Lung - mortality / Carcinoma, Non-Small-Cell Lung - pathology / Care and treatment / Cell receptors / Chemotherapy / Comparative analysis / Cost benefit analysis / Crizotinib / Development and progression / Disease Progression / Drug therapy / Epidermal growth factor / ErbB Receptors - genetics / Erlotinib Hydrochloride - economics / Erlotinib Hydrochloride - therapeutic use / Evidence-based medicine / Female / Finance / Gefitinib - economics / Gefitinib - therapeutic use / Health aspects / Humans / Indoles / Lung Cancer / Lung cancer, Non-small cell / Lung cancer, Small cell / Lung Neoplasms - drug therapy / Lung Neoplasms - economics / Lung Neoplasms - genetics / Lung Neoplasms - mortality / Lung Neoplasms - pathology / Male / Medical care, Cost of / Middle Aged / Mutation / Oncology, Experimental / Patient outcomes / Patients / Pharmaceutical industry / Pharmacology, Experimental / Physiological aspects / Prognosis / Prospective Studies / Pyrimidines