Personalized medicine is considered a savior for both health care delivery and the laboratory sector. Patients receive guidance specific to them on how to attack their disease, and the lab sector would reap the benefits from marketing and distributing assays that often cost well into the four figures. But a new study published in the journal Health Affairs by researchers at UCLA, UC San Francisco and Harvard University concludes that income is a barrier to many patients obtaining such testing, regardless of whether they have insurance to cover the procedure. The study examined 1,847 women in 31 states who were treated for breast cancer. All had insurance from Aetna (the health plan provided de-identified data for the study). According to the study, 12.5 percent of the women underwent the Oncotype DX assay, developed and distributed by California-based molecular laboratory Genomic Health to help target chemotherapy and other treatments. A Genomic Health spokesperson said the test retails for $4,000, but that the lab also offers financial assistance programs to ensure patients have access to the assay. Overall, 12.5 percent of the women in the study used the Oncotype assay, but there was wide divergence of its use among income levels. A […]
Personalized medicine is considered a savior for both health care delivery and the laboratory sector. Patients receive guidance specific to them on how to attack their disease, and the lab sector would reap the benefits from marketing and distributing assays that often cost well into the four figures.
But a new study published in the journal Health Affairs by researchers at UCLA, UC San Francisco and Harvard University concludes that income is a barrier to many patients obtaining such testing, regardless of whether they have insurance to cover the procedure.
The study examined 1,847 women in 31 states who were treated for breast cancer. All had insurance from Aetna (the health plan provided de-identified data for the study).
According to the study, 12.5 percent of the women underwent the Oncotype DX assay, developed and distributed by California-based molecular laboratory Genomic Health to help target chemotherapy and other treatments. A Genomic Health spokesperson said the test retails for $4,000, but that the lab also offers financial assistance programs to ensure patients have access to the assay.
Overall, 12.5 percent of the women in the study used the Oncotype assay, but there was wide divergence of its use among income levels. A total of 16.2 percent of women who earned more than $100,000 a year underwent the test. But only 12.4 percent of women who earned between $50,000 and $100,000 used it. And among those who earned below $50,000, it dropped to 9.5 percent. Moreover, women who resided in regions with high income inequality were 8.4 percent more likely to undergo testing than those who resided in regions with a smaller income gap.
There were also testing gaps by ethnicity. Only 8.6 percent of African-Americans underwent the test, and just 1.5 percent of Hispanic women.
“Income inequality is at an all-time high right now,” said Jennifer Haas, M.D., a study co-author and associate professor at Harvard Medical School’s Brigham and Women’s Hospital, in a statement issued by UCLA. “That it should have a bearing on who gets an innovative test and who doesn’t could lead to more social disparities in cancer care.”
Ninez Ponce, the study’s lead author and associate director of the UCLA Center for Health Policy Research, believes that education may play a role in who uses the test.
“Patients who are higher in socioeconomic status tend to have higher education levels ... and there is more access and wherewithal to research the tools that are available, and I think that’s what is at play there,” Ponce said, although she added that the insurance data does not include education levels.
There were other caveats: The study included data from 2006 and 2007—a long time ago in the molecular testing space, according to Ponce. The impact of deductibles and co-payments were not factored into the study. The Oncotype DX test retails for $4,000, according to a Genomic Health spokesperson. She did not immediately respond to a request seeking further comment.
Ponce believes that there are other drivers at work behind the test utilization gap. Many more academic medical centers operate in areas with higher income, and doctors are in fiercer competition for patients. That may prompt more doctors to offer such testing as part of the services they provide.
“Of those women who do have access, this is shedding light on early diffusion of use,” Ponce said. “The next question is, among those who have access, is it used in a way where decisionmaking is optimized by the test?” She added that a study addressing that question would be published in the near future.
Takeaway: Socioeconomic issues could create unintended barriers to precision medicine—and potentially impact the laboratory sector.
