Large, Prospective Analysis of the Reasons Patients Do Not Pursue BRCA Genetic Testing Following Genetic Counseling

Abstract

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.

Why Patients Decline Genomic Sequencing Studies: Experiences from the CSER Consortium

“…Across the seven participating CSER projects, rates of decline ranged from 12 to 64%, with a median of 28%. This variation is consistent with a large range of decline rates cited in the literature for non-GS genetic research (Sterling et al 2006) and genetic testing (Asscher and Koops 2010; Hayden et al 2017). The average rate of decline varied for CSER projects recruiting adult (36%, N = 5 projects) vs. pediatric participants (21%, N = 2 projects), and healthy individuals (43%, N = 3 projects) vs. those with a disease phenotype (25%, N = 4 projects).…”

“…Several of the reasons cited for declining GS study participation were similar to those cited in the literature in patients being approached for clinical genetic testing and genetic research (Armstrong et al 2003; Asscher and Koops 2010; Hall et al 2005; Hayden et al 2017; Peterson et al 2002; Sterling et al 2006). This includes study logistics which, if addressed, may positively impact GS study enrollment.…”

“…The topic of why patients decline clinical genetic tests and genetic research participation is not new. Reasonss cited for declining clinical genetic testing for hereditary breast and ovarian cancer include concerns regarding costs, discrimination, and confidentiality, as well as patient disinterest (Armstrong et al 2003;Hayden et al 2017;Peterson et al 2002). Patients considering genetic testing for hereditary hemochromatosis also cited having concerns about insurance discrimination (Hall et al 2005).…”

Evolution of genetic assessment for BRCA-associated gynaecologic malignancies: a Canadian multisociety roadmap

“…Importantly, when offered genetic testing, most patients with ovarian cancer proceed with testing7 36–40 and would prefer to receive genetic testing early on in the course of their disease 36 41. In a recent prospective analysis of >10 000 individuals referred for BRCA1/2 genetic counselling and testing, over 85% of patients with ovarian cancer consented to genetic testing and the most common reason to decline testing was concern about out-of-pocket costs, which is irrelevant in the Canadian context 40. The potential therapeutic impact of genetic testing, the widespread use and broad scope of NGS panels, and the consistently high acceptance of genetic testing among patients with ovarian cancer, makes this population of women uniquely suited to consider alternative methods of genetic counselling.…”

The strategic defense of physician autonomy: State public health agencies as countervailing powers

“…Additionally, they showed that nearly 14% of women in Michigan (13.6% or 243 out of 1,611 women) who met the HBOC screening criteria were forced to decline testing because of insufficient insurance coverage. Finally, they illustrated that although some inappropriate testing was occurring in Michigan (approximately 40% of those tested between 2007 and 2011 did not meet screening criteria), it was less common than insurers might have feared (Hayden et al, 2017; MDHHS Cancer Genomics Program, 2012). As noted earlier, national statistics have shown both a recent surge in patient demand for testing (possibly owing to marketing practices of testing laboratories or celebrity disclosures), but also that at-risk women face barriers in accessing screening.…”