Thursday, December 15, 2011

Liberals call on NDP to give a holiday present for Manitoba women

Oncotype Dx testing to improve Breast Cancer diagnosis and treatment is needed in Manitoba: Today, I am calling upon the Minister of Health to implement and fund under medicare the Oncotype DX test for selected newly diagnosed breast cancer patients. It has the potential to exclude many breast cancer patients from receiving chemotherapy, due to each patient’s own tumor characteristics. While this testing is widely available in the United States and is selectively available in Ontario, Quebec and British Columbia, Manitoba’s NDP government is excluding breast cancer patients from this opportunity.

The Oncotype DX test looks at a group of 21 genes within a woman’s tumor sample that are most influential in determining the tumor biology, which can predict more accurately than any previous test the likelihood of a woman’s chances of having her cancer return. The test may rule out that the tumor might not benefit from adding chemotherapy – presently given to most women without any chemotherapy sensitivity testing after initial surgery.

The Oncotype DX test can also improve the quality of life in certain subsets of newly diagnosed breast cancer patients by avoiding unnecessary chemotherapy. It also helps high-risk patients, previously classified as low risk, by ensuring they receive needed chemotherapy.  Tens of thousands of dollars each month could be saved in Manitoba.

Dr. Joseph Ragaz, Medical Director of the UBC and WHC Breast Cancer Prevention and Risk Reduction Clinic, says "Most cancer based research data, and the comprehensive Cancer Advocacy Coalition of Canada [CACC] 2010-2011 overview of the subject, agree the test is cost effective.  Most US-based guidelines and increasing number of Canadian institutions are calling for routine testing with Oncotype DX in the selected cohort of newly diagnosed breast cancer patients.”

I believe this would be a wonderful holiday season gift for breast cancer patients if the Minister of Health would announce today she will fund in Manitoba the OncoType Dx testing for appropriate breast cancer patients.

Linda Minuk joined me today for this announcement (photo above).  She emphasized that this testing can save considerable toxic chemotherapy for many breast cancer patients.  She also emphasized the importance of informing newly diagnosed breast cancer patients in Manitoba about the testing.  At present it is available to patients at a cost of $3700 to the patient.  We believe this cost should be covered under medicare because evidence has shown it improves the quality of diagnosis and treatment in women with hormone receptor positive breast cancer.

Backgrounder on Oncotype DX (21-Gene Assay)
The Oncotype DX test is a diagnostic test which is designed to help women with some types of breast cancer learn more about the biological activity of their specific tumor and to receive improved treatment.

In 2007, the expert panels of both ASCO and NCCN recommended the 21-gene assay as evidence-based. Since then, in most parts of USA, the Oncotype Dx testing became routine care for all node negative breast cancer patients whose tumours tested positive for hormone receptors.

Along with other pieces of information, the results from the Oncotype DX test can help women and their doctors make decisions about whether or not to include chemotherapy in their treatment plan. It can also help indicate how likely it is that a woman’s cancer may return in the future.

The Oncotype DX test looks at a group of 21 genes within a woman’s tumor sample—16 cancer genes and 5 control genes—to see how they are expressed, or how active they are. The results of the test are reported as a quantitative result, which is a score between 0 and 100 that correlates with the likelihood of a woman’s chances of having her cancer return, and the likelihood that she will benefit from adding chemotherapy to her hormonal therapy.

Currently, each tumour sample to be tested must be shipped to a centralized laboratory of the patent-holding company in Redwood, California. They receive specimens from around the world, and no other laboratory is in position to perform the test. The test costs $3,700 per sample.

In 2005, the 21-gene assay was approved by the US Food and Drug Administration (FDA) and has been used increasingly throughout the US. In 2007, the expert panels of both ASCO and NCCN recommended the 21-gene assay as evidence-based. Since then, in most parts of USA, the Oncotype Dx testing became routine care for all node negative breast cancer patients whose tumours tested positive for hormone receptors.

Currently, the majority of US insurance companies cover the cost of the assay. Thus, the 21-gene assay is available to virtually all US breast cancer patients who are node negative and, recently, also to the low risk node positive cases, if estrogen receptor positive.

Until 2009, this test was virtually unavailable in Canada outside clinical trials.

With data mounting on the benefit of using the 21-gene assay, Canadian provinces have responded as follows:

• British Columbia began a registration study for the 21- gene assay in 2010. However, it is restricted to node negative cases and until recently was active only in the Vancouver clinic.

• Ontario started funding the 21-gene assay more consistently, using an OHIP provision for out-of-country health services, which requires an application by the oncologist and prior approval from the health ministry.

• In the last few months, Quebec’s RAMQ has started funding an increasing number of 21-gene assay tests.

Presently in Manitoba, the 21-gene assay is available for women with breast cancer who are willing to pay for it (approximately $4,000). It is not covered under medicare in Manitoba.

Information provided by:
The 21-Gene Assay: Impact on breast cancer in Canada
By Joseph Ragaz, MD, FRCPC
http://www.canceradvocacy.ca/reportcard/2009/pdf/The%2021%20Gene%20Assay%20-%20Impact%20on%20Breast%20Cancer%20in%20Canada%20-%20Joseph%20Ragaz.pdf

The 21-Gene Assay: Canada’s Uneven Response
By Joseph Ragaz, MD, FRCPC
http://www.canceradvocacy.ca/reportcard/2011/The%2021-Gene%20Assay%20Canadas%20Uneven%20Response.pdf

Saving Lives: Saving Dollars: This announcement is one more in a series of Liberal announcements focusing on saving lives and saving dollars.

Make a Donation to support our efforts: To help our Manitoba Liberal Party efforts to promote the health of women, we ask for your support. Please go to http://mlp.manitobaliberals.ca/ and click on DONATE NOW to make an on-line donation.