Barriers to obtaining gene expression profiling tests increase their perceived value among patients

Barriers to obtaining gene expression profiling tests increased their perceived importance among patients with early breast cancer (estrogen-receptor positive [ER+], human epidermal growth-factor receptor 2 negative [HER2–], and node negative) who were deciding whether to have chemotherapy after surgery, according to a new study from Canada.

Gene expression profiling tests, such as Oncotype Dx, analyze the patterns of 21 different genes within cancer cells. This information helps predict if chemotherapy will be beneficial and if a women's cancer is likely to recur within 10 years of initial treatment.

Gene expression profiling tests are one of the first personalized medicine technologies translated into clinical practice. Access to this technology in Canada is subject to careful administration and oversight because testing is expensive ($4,000). Ontario was the first province in Canada to fund gene expression profiling tests.

However, this has had unintended consequences. Oncologists have become gatekeepers for testing and this may lead to patient perceptions of inequalities in access.

 “There was a sense that the test was difficult to obtain, which heightened patients' desire for it and led them to see gene expression profiling tests as the deciding factor in their chemotherapy decisions,” said Yvonne Bombard, PhD, a researcher at the Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada. Bombard interviewed 14 oncologists and 28 patients with breast cancer in Ontario for the study.

Some oncologists offered the test to all their patients, but other oncologists offered testing only to those who were eligible or in situations where there was uncertainty about the value of chemotherapy. Some oncologists discussed testing early in their consultations with patients, others late in the process.

This led some patients to think their doctors had already made the decision to recommend chemotherapy. Bombard said some patients felt that information about the test was withheld because of the high cost.

Some patients said they learned about the tests from media reports that described a lack of funding in Canada and that framed the issue as one of inequitable access to a game-changing technology. Several of the oncologists said they felt pressured by media coverage to offer the test to women for whom they knew it would not provide useful information for decision-making about chemotherapy.

Extra paperwork was another barrier to testing. Because the test is not performed in Canada, patients and oncologists had to fill out forms to establish eligibility for Ontario Health Insurance Plan reimbursement. Oncologists were required to obtain government approval before sending tumor samples out of the country for testing. Usually, test results are received in approximately 3 weeks. This extra paperwork was cumbersome, increased anxieties about missing the window to start treatment, and reinforced the impression that the test was special because it warranted special attention.

This study was published in Current Oncology (2014; doi: 10.3747/co.21.1782).

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