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Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests
BACKGROUND: Treatment for patients with breast cancer (BC) is guided by human epidermal growth factor receptor 2 (HER2) status. The patient’s HER2 status is assessed using US Food and Drug Administration-approved in vitro diagnostic (IVD) immunohistochemical (IHC) tests and laboratory-developed IVD...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4553016/ https://www.ncbi.nlm.nih.gov/pubmed/26318869 http://dx.doi.org/10.1186/s12913-015-1018-6 |
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author | Vyberg, Mogens Nielsen, Søren Røge, Rasmus Sheppard, Beth Ranger-Moore, Jim Walk, Eric Gartemann, Juliane Rohr, Ulrich-Peter Teichgräber, Volker |
author_facet | Vyberg, Mogens Nielsen, Søren Røge, Rasmus Sheppard, Beth Ranger-Moore, Jim Walk, Eric Gartemann, Juliane Rohr, Ulrich-Peter Teichgräber, Volker |
author_sort | Vyberg, Mogens |
collection | PubMed |
description | BACKGROUND: Treatment for patients with breast cancer (BC) is guided by human epidermal growth factor receptor 2 (HER2) status. The patient’s HER2 status is assessed using US Food and Drug Administration-approved in vitro diagnostic (IVD) immunohistochemical (IHC) tests and laboratory-developed IVD tests. We analysed HER2 testing accuracy using data from the Nordic Immunohistochemistry Quality Control (NordiQC) HER2 IHC programme; results were used in an economic BC treatment model. METHODS: Data were obtained from NordiQC HER2 BC surveys performed from 2008 to 2012. False-negative (FN) and false-positive (FP) rates for approved and laboratory-developed IVDs were used to estimate direct costs, loss of survival, productivity benefit and quality-adjusted life-years. In the absence of consistent and accessible clinical and economic data from countries participating in the NordiQC programme, United States productivity data, healthcare costs and patient numbers were used as a surrogate in order to estimate the potential impact of selecting an approved or laboratory-developed IVDs. RESULTS: In total, 1703 tests were performed. Pooled FN rates were 11 % for approved IVDs and 25 % for laboratory-developed IVDs; FP rates were 0 % and 5 %, respectively. Using these FP and FN rates in the economic model and applying them to the United States BC population, approved IVD tests would result in better clinical outcomes, i.e., better survival and fewer disease recurrences/progressions, and lower costs, i.e., total direct costs and lost productivity, versus laboratory-developed IVD tests. Every $1 saved by laboratories by using cheaper reagents could potentially result in approximately $6 additional costs to the healthcare system. CONCLUSIONS: The results of this analysis suggest that incorrect HER2 test results have far-reaching clinical and economic consequences. |
format | Online Article Text |
id | pubmed-4553016 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-45530162015-08-30 Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests Vyberg, Mogens Nielsen, Søren Røge, Rasmus Sheppard, Beth Ranger-Moore, Jim Walk, Eric Gartemann, Juliane Rohr, Ulrich-Peter Teichgräber, Volker BMC Health Serv Res Research Article BACKGROUND: Treatment for patients with breast cancer (BC) is guided by human epidermal growth factor receptor 2 (HER2) status. The patient’s HER2 status is assessed using US Food and Drug Administration-approved in vitro diagnostic (IVD) immunohistochemical (IHC) tests and laboratory-developed IVD tests. We analysed HER2 testing accuracy using data from the Nordic Immunohistochemistry Quality Control (NordiQC) HER2 IHC programme; results were used in an economic BC treatment model. METHODS: Data were obtained from NordiQC HER2 BC surveys performed from 2008 to 2012. False-negative (FN) and false-positive (FP) rates for approved and laboratory-developed IVDs were used to estimate direct costs, loss of survival, productivity benefit and quality-adjusted life-years. In the absence of consistent and accessible clinical and economic data from countries participating in the NordiQC programme, United States productivity data, healthcare costs and patient numbers were used as a surrogate in order to estimate the potential impact of selecting an approved or laboratory-developed IVDs. RESULTS: In total, 1703 tests were performed. Pooled FN rates were 11 % for approved IVDs and 25 % for laboratory-developed IVDs; FP rates were 0 % and 5 %, respectively. Using these FP and FN rates in the economic model and applying them to the United States BC population, approved IVD tests would result in better clinical outcomes, i.e., better survival and fewer disease recurrences/progressions, and lower costs, i.e., total direct costs and lost productivity, versus laboratory-developed IVD tests. Every $1 saved by laboratories by using cheaper reagents could potentially result in approximately $6 additional costs to the healthcare system. CONCLUSIONS: The results of this analysis suggest that incorrect HER2 test results have far-reaching clinical and economic consequences. BioMed Central 2015-08-29 /pmc/articles/PMC4553016/ /pubmed/26318869 http://dx.doi.org/10.1186/s12913-015-1018-6 Text en © Vyberg et al. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Vyberg, Mogens Nielsen, Søren Røge, Rasmus Sheppard, Beth Ranger-Moore, Jim Walk, Eric Gartemann, Juliane Rohr, Ulrich-Peter Teichgräber, Volker Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests |
title | Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests |
title_full | Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests |
title_fullStr | Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests |
title_full_unstemmed | Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests |
title_short | Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests |
title_sort | immunohistochemical expression of her2 in breast cancer: socioeconomic impact of inaccurate tests |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4553016/ https://www.ncbi.nlm.nih.gov/pubmed/26318869 http://dx.doi.org/10.1186/s12913-015-1018-6 |
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