'Real-World' Data Needed for Breast Cancer Genetic Testing

Roxanne Nelson

December 30, 2013

Genomic diagnostic tools such as OncoType DX (Genomic Health, Inc), MammaPrint (Agendia), and Cancer-TYPE ID (bioTheranostics) may help personalize treatment of breast cancer and, as a result, improve outcomes and reduce costs. However, some insurers are reluctant to pay for such tests in the absence of "real-world data," as most research on the economic value of genetic testing in breast cancer has relied on modeling rather than translational research or data from clinical trials, according to a review published in the December 2014 issue of the American Journal of Managed Care.

Author Robert D. Lieberthal, PhD, representing the Jefferson Population Health Continuing Professional Education Collaborative, Philadelphia, Pennsylvania, and colleagues found that overall, economic research on genomic testing for breast cancer has not involved randomized controlled trials or other direct trial data and that it relied primarily on modeling. "Our key findings are that research in this area has been limited and is likely to consist primarily of modeling studies for the foreseeable future," Dr. Lieberthal writes. "Additional funding, better outcomes data, and regulation are identified as barriers to adoption of this new technology."

He adds, "The cooperation of multiple stakeholders will be essential if genomic medicine is to reach its full potential. The barrier to progress for genomic medicine is the lack of empirical evidence for the clinical utility and value of genomic testing."

"As the healthcare system works to find ways to pay for genomic technology and healthcare costs continue to trend upward, the potential cost savings and productivity gains associated with advances in genomic diagnostics and personalized treatment that avoid unnecessary and ineffective treatments are appealing," he writes.

Dr. Lieberthal notes that the annual financial cost of breast cancer care in the United States is $13.9 billion, which represents the largest portion of all cancer care expenditures.

Benefits of Testing

The most significant benefit expected from using genomic testing to tailor treatment was a reduction in adverse drug effects for subpopulations that may not benefit from chemotherapy. Another major benefit is the extended quality-adjusted life years.

Included in the analysis were 5 cost-effectiveness studies of Oncotype DX, all of which concluded that treatment guided by genomic testing is cost-effective compared with conventional treatment that is selected according to guidelines. In 1 study, for example, treatment pathways were changed from the initial recommendation (according to traditional prognostic pathways) in 40% of patients and the incremental cost-effectiveness ratio for using Oncotype DX was $10,770 per quality-adjusted life year ( Value Health. 2010;13:381-387).

Patient reimbursement for genomic testing largely depends on the type of insurance the patients have. Oncotype DX is widely used and reimbursed for, and Medicare will often cover the cost. One study in the analysis evaluated the coverage strategy for Oncotype DX and found that all payers prioritized clinical evidence as the most important decision factor ( Oncol Pract. 2010;6:238-242). Medical society recommendations were also important, and most payers did not appear concerned that the Oncotype DX has not received US Food and Drug Administration approval.

Dr. Lieberthal notes that although the economic analysis studies reviewed in the article make a case for the cost-effectiveness of genomic testing for breast cancer treatment decision making, more data are needed. For example, additional data are needed to show the projected benefits that could be realized in real-world settings. "Trials centered around the actual use of such tests in the breast cancer population are necessary to bolster the evidence base," he writes.

The cooperation of multiple stakeholders is also essential if genomic medicine is to reach its full potential, he adds. "The barrier to progress for genomic medicine is the lack of empirical evidence for the clinical utility and value of genomic testing. The literature appears to support the need for additional studies to evaluate the value of genomic testing for breast cancer."

This article was written as part of an education grant funded by Genomic Health. The author has disclosed no relevant financial relationships.

Am J Manag Care. 2013;19:1024-1031. Abstract

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