A study has evaluated the current and future impact of genomic diagnostics on health outcomes and costs for breast cancer. It found that the growing number of these tests available in the U.S. could have major implications for healthcare delivery.
Oncotype DX ’ a 21-gene profile assay ’ is the most commonly used gene expression profiling test in clinical practice in the United States, according to the study. It gives a score that classifies patients in one of three categories: high risk, intermediate risk and low risk. Another gene profiling assay called MammaPrint ’ evaluates 70 genes in a microarray evaluation and is used more frequently in Europe.
The study was done by Amalia M. Issa, chair of the department of health policy and public health and director of the program in personalized medicine and targeted therapeutics at the University of the Sciences’ Mayes College of Healthcare Business and Policy. It was published by Cancer earlier this year.
OnctypeDX has been used in the U.S. since 2004 with the majority of payers reimbursing for it for node-negative breast cancer. But as Issa points out, “New genomic diagnostics are entering the market with increasing frequency,’ said Issa in an e-mailed response to questions. “To date there has been little analysis the current and future impact of genome diagnostics on health outcomes, costs and utilization. We sought to fill that gap.”
The study, conducted from a third party payer’s perspective, took a hypothetical situation of 1,000 women with early stage lymph node-negative, estrogen receptor-positive breast cancer. It used a 10-year model to represent changing health states and compare the costs and quality-adjusted life years associated with using the two most popular GEP-guided treatment strategies in Europe and the U.S. to determine the course of treatment for them. Among the costs considered were the expenses generated from the administration of the gene test, dispensation of chemotherapy, and the cost of treating recurrence, adverse events and end-of-life care.
Those who received the most common U.S. test OncotypeDX spent more ($27,882) and but had less quality of life years, having gained 7.36 compared with the most common European assay MammaPrint ($21,598) with 7.461 quality of life years.
“There is a clear need for more evidence-based decision making in the field of personalized medicine by the different stakeholders involved ’ patients, providers payers and others,” Issa said.
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