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Genomic Health Stresses Oncotype DX Value After Questions Raised by Recent Study

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NEW YORK (GenomeWeb) – Genomic Health reiterated this week its expectation that 2019 will be a year of increasing global demand for the company's Oncotype DX breast cancer recurrence score test in the wake of the TAILORx trial last year and as it prepares to distribute its first kits with partner Biocartis.

Discussing its 2018 financial results call on Wednesday, company officials pivoted from talk of the impact of the TAILORx data that has dominated much of the last six months to discussing newer research focused on the health economics of its assay in breast cancer treatment decision-making.

President, CEO, and Board Chairman Kim Popovits said during the call that Genomic Health is "delivering on the promise of precision medicine by improving outcomes for cancer patients while saving healthcare systems around the world billions of dollars."

The firm's earnings call came just a few weeks after the publication of a study by Yale investigators in the Journal of the National Comprehensive Cancer Network that raised questions about whether the cost-effectiveness of Oncotype DX extends across all patients, or if there might be a subset for whom the test is offering minimal benefit for its cost.

According to the authors, led by Yale professor Cary Gross, the study's modeling results suggested that Oncotype DX is "not cost-effective for women with clinical low-risk breast cancer, which constitutes most patients with ER-positive disease."

Although Genomic Health officials didn't mention the Yale analysis by name, a significant proportion of their discussion on Wednesday was focused on this question of health economic value.

CSO Steve Shak, for example, cited evidence from TAILORx that he argued shows that "patients will be frequently mistreated when decisions are based on clinical risk features alone."

Specifically, he said "25 percent of patients with a low recurrence score [in the study] — from zero to 25 — have high clinical risk," the implication being that these patients would be significantly overtreated without the use of Oncotype DX.

"Conversely, 43 percent of patients with a high recurrence score — from 26 to 100 — had low clinical risk," Shak added. "Therefore, based on clinical risk alone, [these] patients would be significantly undertreated despite their cancer having a high likelihood of a preventable distant recurrence, which is much more difficult and expensive to treat."

"Oncotype DX is the only test that improves outcomes and lowers cost compared to other prognostic tests or to no testing at all," he said during the call, adding that a number of health economic studies have consistently shown that the test offers cost savings at a rate that the company believes has resulted in "billions of dollars in health care savings globally to date."

"When we started offering Oncotype DX more than 70 percent of women were being treated with chemotherapy, and we now know based on TAILORx that a great many patients were being overtreated. With the use of [the test] over the past 15 years, we are seeing increasing de-escalation of unnecessary chemotherapy in clinical practice and the associated cost savings to the healthcare system," Shak explained.

One recent health economic analysis he cited on Wednesday is a study published in the Journal of Comparative Effectiveness Research, which Shak said indicated that Oncotype DX is "the only genomic breast cancer test associated with both a reduction in distant recurrences and a decrease in chemotherapy utilization … lowering both unnecessary toxicities and health care costs."

He also mentioned multiple presentations that were made late last year at the San Antonio Breast Cancer Symposium, including two analyses providing new clarity regarding the value of the test regardless of race or ethnicity.

The JNCCN study focused on a narrower question of cost effectiveness, or health economic value: whether the overall cost effectiveness of Oncotype DX that Genomic Health has demonstrated in other studies — and which held up in their analysis — might not extend equally across all early breast cancer patients.

To study this, the investigators created models to calculate costs and quality-adjusted life years (QALYs) gained over the lifetime for a group of women from the Connecticut Tumor Registry. They classified the 2,245 patients diagnosed between 2011 and 2013 into three groups based on a clinical risk algorithm developed by the UK's National Health service, called PREDICT, and then cross referenced that to Oncotype DX recurrence score distributions within each group.

Oncotype DX testing did provide cost-effective decision support in the cohort overall and for patients in the clinically intermediate- and high-risk groups. However, in the low clinical risk group — which represents a significant majority of early ER-positive breast cancers — only about 3 percent of patients had results that would lead oncologists to recommend chemotherapy where they otherwise wouldn't, the authors reported.

As a result, incremental cost-effectiveness ratios differed across the three clinical risk groups, ranging from $124,600 per QALY in the low-risk group, to $28,700 per QALY in the intermediate-risk group, to $15,700 per QALY in the high-risk group.

In an email to GenomeWeb, a Genomic Health spokesperson reiterated that the company is confident in the research that has demonstrated that Oncotype DX improves outcomes and lowers costs compared to other prognostic tests or no testing at all.

"Cost effectiveness analyses are complex and highly sensitive to the assumptions underlying individual economic models. More than 20 studies across the world have shown Oncotype DX is cost-effective, and often cost-saving, even with varying assumptions, practice patterns, and healthcare costs," the company added.

Genomic Health also highlighted a perspective that Lori Goldstein of the Fox Chase Cancer Center, a Member of the NCCN Guidelines Panel for Breast Cancer, made alongside the announcement of the Yale study last month.

"I applaud any efforts to reduce unnecessary testing and chemotherapy in patients where there is no benefit," Goldstein's statement said. "However, the current recommendation in the NCCN Guidelines for use of Oncotype DX … has been validated in prospective randomized clinical trials."

While the present analysis raises thoughtful questions, she added "[current] NCCN recommendations remain appropriate [and] the current costs associated with the Oncotype DX test seem justifiable based on patient benefit … until future prospective randomized trials are able to further help confirm subsets of patients with no clear benefit from additional chemotherapy."

As it seeks to drive international expansion of its breast cancer testing business, Genomic Health is also counting on continued non-economics-focused research. Shak also highlighted during the call a recent publication in Nature partner journal Breast Cancer, from a new analysis in 569 patients from the previously completed NSABP D 20 study.

According to Shak, the results reiterate the findings from TAILORx last year, showing a statistically significant benefit from the addition of chemotherapy to hormonal therapy in patients with Oncotype DX recurrence scores from 26 to 100.

He also said that recent analyses, including one study of thousands of patients in the SEER registry who were treated based on Oncotype DX results, have provided strong evidence that node-negative results can be extrapolated to node-positive disease.

To support what the company believes will be increasing international demand for Oncotype DX breast cancer testing, the firm is pushing forward with its deal with Biocartis to develop a kit version of the assay that can be disseminated and performed locally in customer labs.

Development has been going well enough that the firm formally extended the agreement to also include development of a kit version of its prostate cancer GPS test.

"It's absolutely the right time to evolve and expand our model to maximize our global reach [and] there is very intense interest in many countries for a local solution," Shak said during the call on Wednesday.

Based on progress with Biocartis so far, Genomic Health has been able to make plans to initiate equivalence studies, recruiting sites in France and Germany, with plans to place systems at those sites before the end of this year, he added.