Biotechnology Healthcare - June 2008 - (Page 41) “It’s a field that’s full of both hype and nonsense, but at the same time, there’s a lot of wonderful substance there,” says Richard M. Simon, DSc, at the NCI. tential advantage of the GeneSearch Breast Prognostic Assay, which was developed and validated in lymph node-negative breast cancer patients regardless of age, tumor size, grade, menopausal, and ER status. Wang states that the assay’s 90 to 95 percent sensitivity rate compares favorably to other tests, but, more importantly, distinguishes breast tumors with a very low risk of recurrence, 5 percent or less, versus those with a much higher risk, between 30 and 40 percent. It may offer a reliable way to identify patients who can be cured by surgery alone without aggressive and toxic chemotherapy, he says. Wang attributes at least part of the difference in test performance to the “whole genome” development approach versus the “targeted gene” development approach that some other tests use. “In the discovery data published in The Lancet, we pointed out that among the 76 genes in the prognostic signature, there are 18 novel genes about which we don’t have prior knowledge of their biological function,” says Wang. “In other words, this data highlights the power of the whole genome approach to identify not only the genes that have been implicated in breast cancer, but also new genes whose relationship to the underlying disease is not yet understood. That’s probably part of the reason why this kind of gene signature performed better than some of the other tests.” WONDERFUL SUBSTANCE Most payers have dedicated nurses and physicians who track and evaluate new technologies for which coverage policies may have to be developed. Their evaluation process is similar to how the ASCO Update Committee reached its recommendations, such as determining whether the clinical trials are well designed and the biostatistical analyses correctly performed. “This is a huge issue because there are very few truly doubleblinded studies that allow us to make firm decisions on a new technology,” says Louis I. Hochheiser, MD, medical director of clinical policy development at Humana. “Molecular diagnostics companies are trying to bring their products to market as quickly as possible, and the level of evidence that you really would like to have is oftentimes not there.” Which is why Hochheiser and colleague Bryan Loy, MD, MBA, medical officer in Humana’s Kentucky market office, welcome ASCO’s evaluations and recommendations. In the interim, Hochheiser says Humana is hiring more people to focus solely on the fastgrowing molecular diagnostics category. The upside of these new gene expression assays for payers could be lower total costs. Data from 2005 estimated that compared with treatment decisions based on NCCN criteria, clinical decisions based on Oncotype DX results could boost average quality-adjusted survival by 8.6 years and reduce overall costs by $202,828 for 100 theoretical U.S. patients. Still, many payers are concerned about adopting this new technology indiscriminately. “This field has exploded in the last 6 to 9 months with a high level of awareness and a lot of promise about where things can go,” says Hochheiser. “But it’s being pushed so fast that the medical evidence may not yet support its usefulness in the clinical setting. We need to ensure that the medical evidence is there, enabling us to appropriately take care of people’s medical problems.” Humana, though, has made an early decision, based on medical evidence, to adopt Oncotype testing. Patients should have the access to the latest technology, Hochheiser believes, as long as they are protected from harm. Simon at the NCI also encourages buyers and payers alike to beware of what they hear and read about molecular diagnostics. He agrees that it will take time before we understand tumor biology better and why tests like Oncotype DX work, but he doesn’t think this is a time to “step back.” “It’s a field that’s full of both hype and nonsense, but at the same time, there’s a lot of wonderful substance there,” says Simon. “To imply that this technology isn’t mature and not to be trusted I think is erroneous. Trying to understand the biology of a disease is a lifetime’s worth of work. Let’s not make the mistake of saying we’re not going to accept the use of such a test unless we understand why it works biologically.” Laurie Levin and tens of thousands of other women, one suspects, would agree. Bob Carlson, MHA, writes exclusively about healthcare. He lives near Zionsville, Ind. MAY/JUNE 2008 · BIOTECHNOLOGY HEALTHCARE 41
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