Economic assessment of NGS testing workflow for NSCLC in a healthcare setting
Davide Seminati,
Vincenzo L'Imperio,
Gabriele Casati,
Joranda Ceku,
Daniela Pilla,
Carla Rossana Scalia,
Gianluca Gragnano,
Francesco Pepe,
Pasquale Pisapia,
Luca Sala,
Diego Luigi Cortinovis,
Francesca Bono,
Umberto Malapelle,
Giancarlo Troncone,
Silvia Novello,
Fabio Pagni
Affiliations
Davide Seminati
Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy
Vincenzo L'Imperio
Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy
Gabriele Casati
Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy
Joranda Ceku
Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy
Daniela Pilla
Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy
Carla Rossana Scalia
Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy
Gianluca Gragnano
Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy
Francesco Pepe
Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy
Pasquale Pisapia
Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy
Luca Sala
Department of Medicine and Surgery, Oncology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy
Diego Luigi Cortinovis
Department of Medicine and Surgery, Oncology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy
Francesca Bono
Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy
Umberto Malapelle
Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy
Giancarlo Troncone
Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy
Silvia Novello
Department of Oncology, University of Turin, Azienda Ospedaliero Universitaria San Luigi, Turin, Italy
Fabio Pagni
Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy; Corresponding author. Department of Pathology Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca Via Pergolesi, 33, Monza, Italy.
Background: The molecular diagnostic and therapeutic pathway of Non-Small Cell Lung Cancer (NSCLC) stands as a successful example of precision medicine. The scarcity of material and the increasing number of biomarkers to be tested have prompted the routine application of next-generation-sequencing (NGS) techniques. Despite its undeniable advantages, NGS involves high costs that may impede its broad adoption in laboratories. This study aims to assess the detailed costs linked to the integration of NGS diagnostics in NSCLC to comprehend their financial impact. Materials and methods: The retrospective analysis encompasses 210 cases of early and advanced stages NSCLC, analyzed with NGS and collected at the IRCCS San Gerardo dei Tintori Foundation (Monza, Italy). Molecular analyses were conducted on FFPE samples, with an hotspot panel capable of detecting DNA and RNA variants in 50 clinically relevant genes. The economic analysis employed a full-cost approach, encompassing direct and indirect costs, overheads, VAT (Value Added Tax). Results: We estimate a comprehensive cost for each sample of €1048.32. This cost represents a crucial investment in terms of NSCLC patients survival, despite constituting only around 1% of the expenses incurred in their molecular diagnostic and therapeutic pathway. Conclusions: The cost comparison between NGS test and the notably higher therapeutic costs highlights that the diagnostic phase is not the limiting economic factor. Developing NGS facilities structured in pathology networks may ensure appropriate technical expertise and efficient workflows.
