Barriers to obtaining gene expression profiling tests heightened their perceived importance among patients with early breast cancer who were deciding whether to have chemotherapy, a new study says.
Gene expression profiling tests, such as Oncotype Dx, analyze the patterns of 21 different genes within cancer cells to help predict how likely it is that a women's cancer will recur within 10 years after initial treatment and how beneficial chemotherapy will be to her.
Dr. Yvonne Bombard, a genomics and health services researcher in the Li Ka Shing Knowledge Institute of St. Michael's Hospital, found that access to this newly available and expensive technology is subject to careful administration and oversight.
However, she said that has created unintended consequences such as making oncologists gatekeepers for determining when it was medically appropriate for someone to have the test, leading to perceived inequalities in access by patients. Moreover, media attention made patients more aware of the gene expression profiling tests and led them to specifically ask for them, but that complicated physicians' gatekeeping efforts, sometimes hurting the doctor-patient relationship.
"There was a sense that the test was scarce or difficult to obtain, which heightened patients' desire for it and led them to perceive gene expression profiling tests as the deciding factor in their chemotherapy decisions, over and above other clinical tests and indicators," she said.
Dr. Bombard interviewed 14 oncologists and 28 breast cancer patients in Ontario for a study published today in Current Oncology. Ontario was the first province in Canada to fund gene expression profiling tests.
She said the careful oversight required of oncologists to the test created perceived inequities in access among patients. This often occurred in how oncologists discussed the test with their patients. Some oncologists offered the test to all their patients, others only to those who were eligible or where they felt there was uncertainty about the potential value of chemotherapy. Some raised it early in their consultations with patients, others late in the process, leading some patients to feel their doctors had already made the decision to recommend chemotherapy. Dr. Bombard said some patients felt information about the test was not offered to them because of its high cost, $4,000.
"Such delays or omissions in mentioning the test often left patients confused or feeling that something of great value was being withheld," she said.
Some patients said they learned about the tests from media reports describing a lack of funding in Canada that framed the issue as one of inequitable access to a highly effective, game-changing technology. Several of the oncologists said they felt pressured by the media coverage to offer the test to women for whom they knew it would not provide useful information for their decision-making about chemotherapy.
Another barrier was the extra paperwork around the test, which is not performed in Canada. Patients and oncologists must fill out forms to establish eligibility for OHIP reimbursement. Oncologists were then required to obtain government approval before sending tumour samples out of the country for testing. Results usually take about three weeks. This extra paperwork was cumbersome, increased anxieties about missing the window to start treatment and also reinforced the impression that the test was special, because it warranted special attention.
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