Purpose: National guidelines recommend a 21-gene recurrence score (RS) to aid in adjuvant treatment decision in patients with estrogen receptor (ER) -positive, lymph node (LN) -negative early-stage breast cancer (ESBC). This study was performed to assess the economic implication of the assay in community practices from the perspective of a US payer. Methods:The study analyzed 952 women with ESBC enrolled with Humana (Louisville, KY) who were tested with the 21-gene RS between June 2006 and June 2010. The proportion of women classified by the assay according to RS risk category, use, and costs of chemotherapy regimens and supportive care, and costs of adverse events were obtained from Humana. We adopted a validated Markov model to compute the cost implications of RS for a representative patient. The probability of risk of recurrence, the chemotherapy benefit, and the decision impact of RS were derived from published studies.Results: Two hundred fifty-five patients within the tested population received adjuvant chemotherapy. Adjuvant chemotherapy was administered to 10% of women at low risk, 36% of women at intermediate risk, and 72% of women at high risk of recurrence. On the basis of a meta-analysis in the reduction of chemotherapy after RS, the model estimated an average test saving of $1,160 per patient. The immediate direct savings for chemotherapy drugs, supportive care, and management of adverse events were $1,885, $2,578, and $472, respectively. Prevention of recurrence through appropriate treatment of patients at high risk resulted in additional savings of $199. Conclusion:The adoption of the 21-gene RS led to targeted management of women with ER-positive, LN-negative ESBC and consequently directed savings to the payer.

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To assess multi-gene assay (MGA) effects on chemotherapy use, toxicities, recurrences, and costs in estrogen receptor-positive early breast cancer. Methods: Meta-analysis performed using data from public databases. Results: Studies included 12,202 women. Relative to no testing, chemotherapy use was higher with 12-gene and 70-gene and lower with PAM50 (commercial) and 21-gene MGAs. Overall, 1643 distant recurrences occurred with no testing, declining by 231 (21-gene), 121 (70-gene), 54 (12-gene) and 94 (PAM50); only the 21-gene assay resulted in no risk of increasing the number of distant recurrences. Relative to 'no testing', total cost of care declined only with 21-gene MGA. Conclusion: MGAs differ in chemotherapy use and related outcomes for women with estrogen receptor-positive early breast cancer.

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)