Economic Utility of a Blood-Based Genomic Test for the Assessment of Patients with Symptoms Suggestive of Obstructive Coronary Artery Disease

Abstract

Approximately 3 million patients with symptoms suggestive of obstructive coronary artery disease (CAD) present to primary care offices in the United States annually, resulting in approximately $6.7 billion in cardiac workup costs. Despite wide application of existing diagnostic technologies, yield of obstructive CAD at invasive coronary angiography (ICA) is low. This study used a decision analysis model to assess the economic utility of a novel gene expression score (GES) for the diagnosis of obstructive CAD. Within a representative commercial health plan's adult membership, current practice for obstructive CAD diagnosis (usual care) was compared to a strategy that incorporates the GES test (GES-directed care). The model projected the number of diagnostic tests and procedures performed, the number of patients receiving medical therapy, type I and type II errors for each strategy of obstructive CAD diagnosis, and the associated costs over a 1-year time horizon. Results demonstrate that GES-directed care to exclude the diagnosis of obstructive CAD prior to myocardial perfusion imaging may yield savings to health plans relative to usual care by reducing utilization of noninvasive and invasive cardiac imaging procedures and increasing diagnostic yield at ICA. At a 50% capture rate of eligible patients in GES-directed care, it is projected that a commercial health plan will realize savings of $0.77 per member per month; savings increase proportionally to the GES capture rate. These findings illustrate the potential value of this new blood-based, molecular diagnostic test for health plans and patients in an age of greater emphasis on personalized medicine. (Population Health Management 2014;17:287-296)

Clinical Utility of a Precision Medicine Test Evaluating Outpatients with Suspected Obstructive Coronary Artery Disease

“…Lastly, our findings may have implications for risk avoidance for patients (by decreasing exposure to radiation and contrast agents) and economic utility for health care systems (through more cost-effective care and decreased overall health expenditures). [26][27][28][29][30][31][32] Our study has several limitations. The absence of a control group in the PRESET Registry limits direct comparisons with usual care, although our multivariate logistic regression analyses indicated a significant association between low ASGES and decreased cardiac referrals, beyond any effects on referral rates due to important demographic and clinical characteristics.…”

The Clinical Utility of a Precision Medicine Blood Test Incorporating Age, Sex, and Gene Expression for Evaluating Women with Stable Symptoms Suggestive of Obstructive Coronary Artery Disease: Analysis from the PRESET Registry

“…24–27 From a societal perspective, the ASGES has been shown to be cost-effective and may reduce overall health care expenditures. 28,29, 30…”

The Diagnosis of CAD in Women: Addressing the Unmet Need—A Report from the National Expert Roundtable Meeting

“…8 There is growing acceptance of genomic testing, particularly as it relates to cancer risk. 40 With the growing acceptance of applied genomics or ''precision medicine,'' the timing and environment seem appropriate for the incorporation of a new diagnostic aid for obstructive CAD that incorporates age, sex, and gene expression inputs to help inform the diagnostic and treatment pathway. The evidence base for the ASGES test is promising.…”

“…8 A cost analysis revealed that substantially fewer nuclear stress MPI tests (4008 vs. 5200) and ICA tests (1742 vs. 2179) would be performed on patients whose risk of obstructive CAD had previously been assessed by an ASGES test and who had low scores. 40 This budget impact modeling study concluded that use of the ASGES test could be associated with costs savings of $0.77 per member per month.…”