OBJECTIVES

: The study aims to compare NGS-based molecular alteration testing with a standard hotspot approach from a cost-perspective. The research provides an estimate of NGS and STD cost per patient in three Italian hospitals, identifying the minimum number of tested patients to allow NGS to generate savings (break-even analysis).

METHODS

The comparison between standard technique-driven testing (STD) and Next Generation Sequencing (NGS) focuses on advanced non-small-cell lung cancer (aNSCLC) and unresectable metastatic colon-rectal cancer (mCRC), and is carried out in 4 different scenarios (“Minimum Set”, “Clinical Practice”, “Future C.P. without Tumor Mutational Burden”, “Future C.P. with TMB”), defined by a different number of molecular alterations tested.

Study design, testing path definition and data collection were conducted involving three Italian Oncological Research Hospitals. Data was collected through a set of interviews based on a semi-structured questionnaire administered to Oncologists, Pathologists, Biologists and Lab technicians.

All analyses were conducted as a comparison between NGS (case) and STD (control), on 3 differential dimensions: personnel time, consumables, equipment purchase and maintenance.

To validate results robustness, Deterministic and Probabilistic Sensitivity Analysis were performed.

RESULTS

: Molecular alterations tested and respective testing techniques were mapped across the hospitals involved, both in current practice and expected evolution. Despite the heterogeneity in alterations tested and techniques used, at the current volumes of hospital activity, NGS generates a cost-saving option compared to STD (saving ranging from €25 to €1.041 per patient). To address variability in hospital volumes, a break-even analysis was conducted: the break-even point ranges, in current scenarios, from 0 to 160 patients. Results were confirmed through sensitivity analyses, in 87% of cases.

CONCLUSIONS

: An NGS approach can be more convenient than the STD one, provided that a minimum number of patients are tested. The study results provide a starting point to inform the regulatory decision-making process on NGS adoption and funding.