CTA: Is the Oncotype DX test used worldwide?

Dr Chao: Yes, it certainly is – it’s publicly funded in the United States, Canada, the United Kingdom, and other countries including Israel, Switzerland, Ireland, Greece, and much of Spain. It is used in every major country in Europe, in Asia, and in Australia. In many of these countries, it’s paid for privately by the patients themselves.

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CTA: I would assume that in every country, the price would be different, based on the structure of the health care system?

Dr Chao: Yes, in countries where it is publicly funded, it might be slightly different in the amount that has been arranged through the government payer. In countries where patients pay for it on their own, it is a little closer to what our list price is. But again, it depends on our distributor network and how that’s arranged.

CTA: What is the price of Oncotype DX?

Dr Chao: The list price is approximately $4,000 in the United States. But no patient is paying for it on their own in the US, because it’s formally reimbursed by Medicare and many of the private plans. As a result, this is something that has essentially been an accepted standard for patients in the process of their health care for estrogen receptor (ER)-positive breast cancer.

CTA: How many patients are being tested with Oncotype DX?

Dr Chao: My sense of this is only about two-thirds of all patients who have ER-positive, HER2-negative, node-negative breast cancer in the United States get the test.

CTA: I understand Oncotype DX is also now being used to test for DCIS. How does this test affect treatment?

Dr Chao: We actually used some of the same genes in the invasive breast cancer test to develop a DCIS assay, the Oncotype DX® Breast DCIS Score™. It is a prognostic test that tells us the risk of having a recurrence of either DCIS or invasive breast cancer for a patient who presents only with a DCIS tumor.

This is an important test because many surgical oncologists believe that there is a tendency to overtreat such patients with radiotherapy. Many patients who have a low risk of DCIS recurrence may be managed more conservatively without radiotherapy.

It is less of a consensus among radiation oncologists today; an area where many experts on consensus panels agree that we need to do more to try to reduce the potential for overtreatment of this group of patients.