Economic assessment of NGS testing workflow for NSCLC in a healthcare setting.


Journal

Heliyon
ISSN: 2405-8440
Titre abrégé: Heliyon
Pays: England
ID NLM: 101672560

Informations de publication

Date de publication:
15 Apr 2024
Historique:
received: 06 02 2024
revised: 29 03 2024
accepted: 03 04 2024
medline: 15 4 2024
pubmed: 15 4 2024
entrez: 15 4 2024
Statut: epublish

Résumé

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. 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). 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. 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.

Sections du résumé

Background UNASSIGNED
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 UNASSIGNED
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 UNASSIGNED
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 UNASSIGNED
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.

Identifiants

pubmed: 38617925
doi: 10.1016/j.heliyon.2024.e29272
pii: S2405-8440(24)05303-9
pmc: PMC11015456
doi:

Types de publication

Journal Article

Langues

eng

Pagination

e29272

Informations de copyright

© 2024 The Authors. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

VL received personal fees (as consultant and/or speaker bureau) from Eli Lilly, Roche, Novartis. PP has received personal fees as speaker bureau from Novartis. UM has received personal fees (as consultant and/or speaker bureau) from Boehringer Ingelheim, Roche, MSD, Amgen, Thermo Fisher Scientific, Eli Lilly, Diaceutics, GSK, Merck, AstraZeneca, Janssen, Diatech, Novartis, and Hedera. GT reports personal fees (as speaker bureau or advisor) from Roche, MSD, Pfizer, Boehringer Ingelheim, Eli Lilly, BMS, GSK, Menarini, AstraZeneca, Amgen, and Bayer. DLC has received personal fees (as consultant and/or speaker bureau) from Boehringer Ingelheim, Roche, MSD, Amgen, Eli Lilly, GSK, Merck, AstraZeneca, Janssen, Novartis. Silvia Novello received personal fees (as consultant and/or speaker bureau) from Sanofi, AstraZeneca, MSD, Bristol-Myers Squibb, Roche, Pfizer, Lilly, Takeda, AbbVie, Boehringer Ingelheim, Bayer, Amgen, BeiGene, Novartis, Janssen. FP has received personal fees (as consultant and/or speaker bureau) from Novartis, Roche, MSD, Amgen, GSK, AstraZeneca, Lilly, LogiBiotech, Diapath. All fees received by the author are unrelated to the current work.

Auteurs

Davide Seminati (D)

Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy.

Vincenzo L'Imperio (V)

Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy.

Gabriele Casati (G)

Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy.

Joranda Ceku (J)

Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy.

Daniela Pilla (D)

Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy.

Carla Rossana Scalia (CR)

Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy.

Gianluca Gragnano (G)

Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy.

Francesco Pepe (F)

Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy.

Pasquale Pisapia (P)

Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy.

Luca Sala (L)

Department of Medicine and Surgery, Oncology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.

Diego Luigi Cortinovis (DL)

Department of Medicine and Surgery, Oncology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.

Francesca Bono (F)

Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy.

Umberto Malapelle (U)

Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy.

Giancarlo Troncone (G)

Department of Public Health, Pathology, University of Naples Federico II, Naples, Italy.

Silvia Novello (S)

Department of Oncology, University of Turin, Azienda Ospedaliero Universitaria San Luigi, Turin, Italy.

Fabio Pagni (F)

Department of Medicine and Surgery, Pathology, Fondazione IRCCS San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy.

Classifications MeSH