A new study by researchers at Harvard University, the University of California–Los Angeles, and the University of Texas Southwestern has found that a genomic test widely used to help determine whether women with a common form of breast cancer should undergo radiation therapy is not cost-effective. The Oncotype Dx DCIS test (Genomic Health, Inc.) is given to patients with ductal carcinoma in situ (DCIS) to improve treatment selection by better identifying the biological potential of tumors to recur. Medicare reimburses approximately $3,400 for the test.
The researchers used a standard willingness-to-pay threshold of $100,000 per quality-adjusted-life-year to determine that implementing the Oncotype Dx DCIS test was not cost-effective. However, the investigators noted that using the Oncotype Dx DCIS score would reduce the proportion of the population undergoing adjuvant radiation, thereby reducing the number of women at risk for potential adverse events. Whether this benefit is sufficient to justify the increased cost should be debated, the authors said.
The new findings were published online in the Journal of Clinical Oncology.
DCIS comprises approximately 25% of breast cancers, and more than 60,000 women are diagnosed with the disease each year in the United States. One of the treatment goals for patients with DCIS is to minimize the risk of a local recurrence while maximizing breast conservation. Despite the significant number of patients with the disease, the risks and optimal treatment remain unknown, resulting in difficulties with clinical decision-making, according to the authors.
Previous research has demonstrated the ability of the Oncotype Dx DCIS test to predict the 10-year risk of developing an ipsilateral breast event (i.e., a local recurrence of the DCIS or an invasive carcinoma) in patients with DCIS treated with breast-conserving surgery without radiation therapy. These results suggest that the Oncotype Dx DCIS test may have potential for selecting women for surgery without radiation, the authors suggest.
The study findings are relevant to physicians to inform them about the cost/benefit of incorporating the Oncotype Dx DCIS score into their clinical practice, the researchers contend.