Cost-effectiveness of Prosigna for Adjuvant Treatment Decisions in Early Breast Cancer: Healthcare Sector and Societal Perspectives

Lars Asphaug; Lars A Akslen; Egil S Blix; Beate Boge; Elin F Borgen; Marianne B Brekke; Ragnhild S Falk; Gry A Geitvik; Bjørnar Gilje; Berit Gravdehaug; Anette Heie; Emiel Janssen; Cecilie E Kiserud; Torgunn Kursetgjerde; Anita Langerød; Jon Lømo; Bård Mannsåker; Elin Mortensen; Pernilla Olsson; Alina C Porojnicu; Sunil X Raj; Oluf D Roe; Hege E G Russnes; Helle K Skjerven; Silje Songe-Møller; Magdalena A Vestlid; Hege O Ohnstad; Bjørn Naume

doi:10.1016/j.clbc.2025.04.011

Cost-effectiveness of Prosigna for Adjuvant Treatment Decisions in Early Breast Cancer: Healthcare Sector and Societal Perspectives

Clin Breast Cancer. 2025 Apr 15:S1526-8209(25)00102-8. doi: 10.1016/j.clbc.2025.04.011. Online ahead of print.

Authors

Lars Asphaug¹, Lars A Akslen², Egil S Blix³, Beate Boge⁴, Elin F Borgen⁵, Marianne B Brekke⁶, Ragnhild S Falk⁷, Gry A Geitvik⁸, Bjørnar Gilje⁹, Berit Gravdehaug¹⁰, Anette Heie¹¹, Emiel Janssen¹², Cecilie E Kiserud¹³, Torgunn Kursetgjerde¹⁴, Anita Langerød⁸, Jon Lømo⁵, Bård Mannsåker¹⁵, Elin Mortensen¹⁶, Pernilla Olsson¹⁷, Alina C Porojnicu¹⁸, Sunil X Raj¹⁹, Oluf D Roe²⁰, Hege E G Russnes²¹, Helle K Skjerven²², Silje Songe-Møller²³, Magdalena A Vestlid²⁴, Hege O Ohnstad²⁵, Bjørn Naume²⁶

Affiliations

¹ Clinical Trials Unit, Oslo University Hospital, Oslo, Norway; Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Oslo, Norway. Electronic address: larasp@ous-hf.no.
² Centre for Cancer Biomarkers CCBIO, Department of Clinical Medicine, Section for Pathology, University of Bergen, Bergen, Norway; Department of Pathology Haukeland University Hospital, Bergen, Norway.
³ Department of Oncology, University of North Norway, Tromsø, Norway; Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
⁴ Department of Oncology, Hospital of Southern Norway, Kristiansand, Norway.
⁵ Department of Pathology, Division of Laboratory Medicine, Oslo University Hospital, Oslo, Norway.
⁶ Department of Pathology, St Olavs Hospital, Trondheim, Norway.
⁷ Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.
⁸ Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.
⁹ Department of Haematology and Oncology, Stavanger University Hospital, Stavanger, Norway.
¹⁰ Department of Breast Surgery, Akershus University Hospital, Lørenskog, Norway.
¹¹ Department of Breast Surgery, Haukeland University Hospital, Bergen, Norway.
¹² Department of Pathology, Stavanger University Hospital, Stavanger, Norway; Department of Chemistry, Bioscience and Environmental Engineering, Stavanger University, Stavanger, Norway; Menzies Health Institute Queensland and Griffith University, Southport, Australia.
¹³ National Advisory Unit for Late Effects after Cancer Treatment, Oslo University Hospital, Oslo, Norway.
¹⁴ Department of Oncology, Møre og Romsdal Hospital Trust, Ålesund, Norway.
¹⁵ Department of Oncology, Nordland Hospital, Bodø, Norway.
¹⁶ Department of Pathology, University of North Norway, Tromsø, Norway.
¹⁷ Department of Breast Surgery, Innlandet Hospital Trust, Hamar, Norway.
¹⁸ Department of Oncology, Vestre Viken Hospital Trust, Drammen, Norway.
¹⁹ Department of Oncology, St Olavs Hospital, Trondheim, Norway.
²⁰ Department of Oncology, Levanger Hospital, Levanger, Norway.
²¹ Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Pathology, Division of Laboratory Medicine, Oslo University Hospital, Oslo, Norway; Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.
²² Department of Breast Surgery, Vestre Viken Hospital Trust, Drammen, Norway.
²³ Department of Oncology, Østfold Hospital Trust, Kalnes, Norway.
²⁴ Department of Breast Surgery, Telemark Hospital Trust, Skien, Norway.
²⁵ Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway.
²⁶ Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

PMID: 40348620
DOI: 10.1016/j.clbc.2025.04.011

Abstract

Background: Gene expression profiling tests such as the Prosigna-assay are used to aid adjuvant treatment decisions in hormone receptor positive (HR+) HER2 negative (HER2-) early breast cancer (EBC). In this evaluation, the cost-effectiveness of Prosigna against immunohistochemical (IHC) markers including Ki-67, was evaluated from the Norwegian healthcare- and societal perspective.

Materials and methods: The treatment decision impact of Prosigna was tested in the prospective, observational EMIT-1 trial. Using individual data collected the first 12 months post-surgery, a decision model was built to project the economic consequences of using the Prosigna compared to IHC-markers for the adjuvant treatment decisions. Health benefits were measured by cost per quality-adjusted life-years (QALYs) and data on income and welfare benefit was obtained from Statistics Norway.

Results: Of 2,178 HR+/HER2- pN0 EBC patients in the EMIT-1 trial, 1,985 had available health economic data and 1,850 had complete income and welfare benefit records. Including all pN0 patients in the Prosigna-test strategy, the test was above the cost-effective threshold (€26,000; incremental cost-per QALY gained (ICER) €255,622) in a healthcare sector perspective. Incorporating also productivity costs, Prosigna was cost-saving (ICER €-435,677). Restricting Prosigna-testing to patients assessed as clear/uncertain chemotherapy candidates, the strategy was cost-effective in both the healthcare and societal perspective (ICER €8884 and €-620170, respectively).

Conclusions: Using the Prosigna-assay for all HR+/HER2- pN0 EBC patients was not cost-effective from a healthcare perspective, but from the societal perspective it was cost-saving. Selecting patients who are clear/uncertain candidates for chemotherapy based on IHC-classification, Prosigna is cost-effective from both perspectives.

Keywords: Adjuvant therapy; Breast cancer; Cost-effectiveness; Decision making; Registry data.