Genomic Testing for Early Breast Cancer: Assessing the Value of Next-Generation Sequencing
Author(s)
Niccolò Morgante, MSc1, Nadine Collins, PhD2, MARJANE LE BAGOUSSE, MBA, MSc, MD3, Martin Strandberg-Larsen, MSc, PhD3.
1NHTA, Copenhagen, Denmark, 2Molecular Diagnostics, Royal Surrey NHS Foundation Trust, Guildford, United Kingdom, 3EMEA Market Access & Medical Affairs, IVD, Veracyte, San Francisco, CA, USA.
1NHTA, Copenhagen, Denmark, 2Molecular Diagnostics, Royal Surrey NHS Foundation Trust, Guildford, United Kingdom, 3EMEA Market Access & Medical Affairs, IVD, Veracyte, San Francisco, CA, USA.
OBJECTIVES: In England and Wales, tumour profiling testing to guide adjuvant chemotherapy decisions in early breast cancer is recommended by NICE as part of standard of care for eligible patients. NICE recommended testing in node negative patients in 2018, later including node positive patients (1-3 nodes) in 2024. Prosigna breast cancer assay is one of the recommended options. Prosigna analysis is currently processed on the nCounterDx platform. This study aimed to assess the economic and organisational impact of offering Prosigna as an assay processed using Next Generation Sequencing (NGS).
METHODS: Starting from the NICE base-case developed in the 2024 guidance, we modelled Prosigna’s cost-utility analysis evolution on nCounterDX and on NGS. The analysis was repeated across increasing test volumes. Using micro-costing data from an English hospital setting, which provided platform-specific resource requirements, we evaluated test costs upon NGS implementation and their impact on the incremental cost-effectiveness ratio (ICER). We used published costs on nCounterDX servicing, Prosigna assay, RNA isolation, and labour. We analysed batch processing capabilities to determine cost-effective per-test costs, benefits of platform consolidation, and optimal utilization across different scenarios. Organizational impact was also evaluated based on qualitative interviews with NGS specialists in the clinical laboratory setting.
RESULTS: With an ICER of £16,397 per QALY gained, implementing Prosigna testing on an NGS platform remains a cost-effective use of health care resources based on NICE thresholds to guide adjuvant chemotherapy decisions. The additional impact of the use of NGS can be described in five categories: platform consolidation, scalability and throughput, expanded molecular information, integration with other assays, and long-term platform stability.
CONCLUSIONS: This is the first field study examining the economic and organizational impact of offering Prosigna on an NGS platform, demonstrating economic and organizational benefits versus nCounterDX processing. Additional validation studies across different settings and perspectives are needed.
METHODS: Starting from the NICE base-case developed in the 2024 guidance, we modelled Prosigna’s cost-utility analysis evolution on nCounterDX and on NGS. The analysis was repeated across increasing test volumes. Using micro-costing data from an English hospital setting, which provided platform-specific resource requirements, we evaluated test costs upon NGS implementation and their impact on the incremental cost-effectiveness ratio (ICER). We used published costs on nCounterDX servicing, Prosigna assay, RNA isolation, and labour. We analysed batch processing capabilities to determine cost-effective per-test costs, benefits of platform consolidation, and optimal utilization across different scenarios. Organizational impact was also evaluated based on qualitative interviews with NGS specialists in the clinical laboratory setting.
RESULTS: With an ICER of £16,397 per QALY gained, implementing Prosigna testing on an NGS platform remains a cost-effective use of health care resources based on NICE thresholds to guide adjuvant chemotherapy decisions. The additional impact of the use of NGS can be described in five categories: platform consolidation, scalability and throughput, expanded molecular information, integration with other assays, and long-term platform stability.
CONCLUSIONS: This is the first field study examining the economic and organizational impact of offering Prosigna on an NGS platform, demonstrating economic and organizational benefits versus nCounterDX processing. Additional validation studies across different settings and perspectives are needed.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE480
Topic
Economic Evaluation, Medical Technologies, Study Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology