TY - JOUR
T1 - Immunohistochemical expression of HER2 in breast cancer
T2 - Socioeconomic impact of inaccurate tests
AU - Vyberg, Mogens
AU - Nielsen, Søren
AU - Røge, Rasmus
AU - Sheppard, Beth
AU - Ranger-Moore, Jim
AU - Walk, Eric
AU - Gartemann, Juliane
AU - Rohr, Ulrich Peter
AU - Teichgräber, Volker
N1 - Publisher Copyright:
© 2015 Vyberg et al.
PY - 2015/8/29
Y1 - 2015/8/29
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84940372080&partnerID=8YFLogxK
U2 - 10.1186/s12913-015-1018-6
DO - 10.1186/s12913-015-1018-6
M3 - Article
C2 - 26318869
AN - SCOPUS:84940372080
SN - 1472-6963
VL - 15
JO - BMC Health Services Research
JF - BMC Health Services Research
IS - 1
M1 - 352
ER -