PMID- 38436289 OWN - NLM STAT- MEDLINE DCOM- 20240314 LR - 20240314 IS - 1941-837X (Electronic) IS - 1369-6998 (Linking) VI - 27 IP - 1 DP - 2024 Jan-Dec TI - A cost-consequence model of using the 21-gene assay to identify patients with early-stage node-positive breast cancer who benefit from adjuvant chemotherapy in the Netherlands. PG - 445-454 LID - 10.1080/13696998.2024.2324612 [doi] AB - BACKGROUND: Patients with early-stage hormone receptor positive, human epidermal growth factor receptor-2 (HER2) negative invasive breast cancer with 1-3 positive lymph nodes (N1) often undergo surgical excisions followed by adjuvant chemotherapy (ACT). Many patients have no benefit from ACT and receive unnecessary, costly treatment often associated with short- and long-term adverse events (AEs). Gene expression profiling (GEP) assays, such as the 21-gene assay (i.e. the Oncotype DX assay), can identify patients at higher risk for recurrence who may benefit from ACT. However, the budgetary consequence of using the Oncotype DX assay versus no GEP testing in the Netherlands is unknown. Our study therefore assessed it using a cost-consequence model. METHODS: A validated model was used to create the N1 model. The model compared the costs and consequences of using the Oncotype DX assay versus no GEP testing and MammaPrint, and subsequent ACT use with corresponding costs for chemotherapy, treatment of AEs, productivity losses, GEP testing, and treatment of recurrences, according to the Oncotype DX results. The model time horizon was 5 years. RESULTS: Costs for the total population amounted to euro8.0 million (M), euro16.2 M, and euro9.5 M, and cost per patient amounted to euro13,540, euro27,455, and euro16,154 for using the Oncotype DX assay, no GEP testing, and MammaPrint, respectively. Total cost savings of using the Oncotype DX assay amounted to euro8.2 M versus no GEP testing and euro1.5 M versus MammaPrint. Using the Oncotype DX assay would result in fewer patients receiving ACT and thus fewer AEs, sick days, and hospitalizations, leading to overall cost savings compared with no GEP testing and MammaPrint. CONCLUSIONS: Implementing Oncotype DX testing in this population can prevent unnecessary overtreatment, reducing clinical and economic burden on the patient and Dutch healthcare system. FAU - Simons, Martijn J H G AU - Simons MJHG AUID- ORCID: 0000-0001-5248-1676 AD - Evidence & Access, OPEN Health, Rotterdam, The Netherlands. FAU - Machielsen, Peter M AU - Machielsen PM AUID- ORCID: 0000-0002-8056-8063 AD - Exact Sciences, Baar, Switzerland. FAU - Spoorendonk, Jelle A AU - Spoorendonk JA AUID- ORCID: 0000-0003-3687-4968 AD - Evidence & Access, OPEN Health, Rotterdam, The Netherlands. FAU - Ignacio, Tim AU - Ignacio T AD - Evidence & Access, OPEN Health, Rotterdam, The Netherlands. FAU - Drost, Pieter B AU - Drost PB AD - Exact Sciences, Baar, Switzerland. FAU - Jacobs, Tim AU - Jacobs T AD - Exact Sciences, Baar, Switzerland. FAU - de Jongh, Felix E AU - de Jongh FE AUID- ORCID: 0000-0002-1925-6263 AD - Ikazia Ziekenhuis Rotterdam, Rotterdam, The Netherlands. LA - eng PT - Journal Article DEP - 20240312 PL - England TA - J Med Econ JT - Journal of medical economics JID - 9892255 SB - IM MH - Humans MH - Female MH - *Breast Neoplasms/drug therapy MH - Netherlands MH - Chemotherapy, Adjuvant MH - Gene Expression Profiling/methods MH - Neoplasm Recurrence, Local/drug therapy OAB - Early-stage invasive breast cancer patients often undergo surgery followed by adjuvant chemotherapy. However, many of these patients have no benefit from adjuvant chemotherapy and thus receive unnecessary and costly treatment often associated with side-effects. Patients who may benefit from adjuvant chemotherapy can be identified by analyzing the genomic profile of the patients' tumors using a molecular diagnostic test called the 21-gene assay (also known as Oncotype DX assay). However, the budgetary consequences of using Oncotype DX for this purpose in the Netherlands are currently unknown and, therefore, assessed using a health-economic model. The model compared the costs and consequences of using the Oncotype DX assay versus no molecular diagnostic testing and an alternative molecular diagnostic test called MammaPrint. The three diagnostic testing strategies resulted in different costs in terms of several different costing categories and were compared with one another. The total costs were lowest for the diagnostic strategy using the Oncotype DX assay, as it would result in fewer patients receiving adjuvant chemotherapy compared with no molecular diagnostic testing and MammaPrint. Implementing the Oncotype DX assay as a molecular diagnostic test can identify the right patient who benefits from chemotherapy (prevent over- and undertreatment) and lead to cost-savings, reducing the clinical and economic burden on the patient and Dutch healthcare system. OABL- eng OTO - NOTNLM OT - 21-gene OT - A OT - A1 OT - A11 OT - C OT - C2 OT - C21 OT - C5 OT - C51 OT - adjuvant chemotherapy OT - breast cancer OT - cost-consequence analysis OT - early stage OT - gene expression profiling OT - hormone receptor OT - human epidermal growth factor receptor 2 OT - lymph node positive EDAT- 2024/03/04 12:45 MHDA- 2024/03/14 06:47 CRDT- 2024/03/04 09:51 PHST- 2024/03/14 06:47 [medline] PHST- 2024/03/04 12:45 [pubmed] PHST- 2024/03/04 09:51 [entrez] AID - 10.1080/13696998.2024.2324612 [doi] PST - ppublish SO - J Med Econ. 2024 Jan-Dec;27(1):445-454. doi: 10.1080/13696998.2024.2324612. Epub 2024 Mar 12.