Large, Prospective Analysis of the Reasons Patients Do Not Pursue BRCA Genetic Testing Following Genetic Counseling
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Genetic counseling (GC) and genetic testing (GT) identifies high-risk individuals who benefit from enhanced medical management. Not all individuals undergo GT following GC and understanding the reasons why can impact clinical efficiency, reduce GT costs through appropriate identification of high-risk individuals, and demonstrate the value of pre-GT GC. A collaborative project sponsored by the Michigan Department of Health and Human Services prospectively collects anonymous data on BRCA-related GC visits performed by providers in Michigan, including demographics, patient/family cancer history, GT results, and reasons for declining GT. From 2008 to 2012, 10,726 patients underwent GC; 3476 (32.4%) did not pursue GT. Primary reasons included: not the best test candidate (28.1%), not clinically indicated (23.3%), and insurance/out of pocket cost concerns (13.6%). Patient disinterest was the primary reason for declining in 17.1%. Insurance/out of pocket cost concerns were the primary reason for not testing in 13.4% of untested individuals with private insurance. Among untested individuals with breast and/or ovarian cancer, 22.5% reported insurance/out of pocket cost concerns as the primary reason for not testing and 6.6% failed to meet Medicare criteria. In a five-year time period, nearly one-third of patients who underwent BRCA GC did not pursue GT. GT was not indicated in almost half of patients. Insurance/out of pocket cost concerns continue to be barriers.
KeywordsGenetic Counseling Genetic Testing Barriers BRCA Insurance Public Health
The Michigan BRCA Clinical Partners Network Publications Group including (in alphabetical order): Kristen Hanson, MS; Sarah Keilman, MS; Sofia Merajver, MD; Kara Milliron, MS; Dana Zakalik, MD; Julie Zenger Hain, PhD
The Michigan BRCA Clinical Partners Network including the following institutional partners (in alphabetical order): Beaumont Cancer Genetics Program, Cancer Genetics Program at St. Joseph Mercy Hospital, Henry Ford Health System, InformedDNA, Karmanos Cancer Genetic Counseling Service, Lacks Cancer Center Genetics Program at St. Mary’s Healthcare, Marquette General Hereditary Cancer Program, Michigan State University Division of Clinical Genetics, MidMichigan Health Cancer Genetics Program, Oakwood Healthcare System’s Genetic Risk Assessment for Cancer Clinic, Providence Hospital Medical Genetics, Spectrum Health Cancer Genetics, University of Michigan – Cancer Genetics Clinic, University of Michigan – Breast and Ovarian Cancer Risk and Evaluation Program, West Michigan Cancer Center
Compliance with Ethical Standards
This publication was supported by the Cooperative Agreement Numbers 5U38GD00054 and 51U58DP003798 from The Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention
Conflict of Interest
Sommer Hayden, Sarah Mange, Debra Duquette, Nancie Petrucelli and Victoria M. Raymond declare that they have no conflict of interest.
Victoria M. Raymond is a full time employee of Trovagene, Inc
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
These data are consistent with public health surveillance and not research as defined by the code of federal regulations (CFR) 46.102 (D) and therefore were deemed exempt by the Michigan Department of Health and Human Services (MDHHS) Institutional Review Board (IRB) for the Protection of Human Research Subjects. The collaborative project was reviewed by the IRB’s of each individual institution.
No animal studies were carried out by the authors for this article.
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