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Questions to ask about
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Genomic Health Corporate Site
www.genomichealth.com
MyTreatmentDecision.com
www.mytreatmentdecision.com
Oncotype DX
www.oncotypeDX.com
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As you may have heard, the Food & Drug Administration (FDA) recently announced that it has granted U.S. marketing clearance for MammaPrint®, a breast cancer prognosis test developed by Agendia. At Genomic Health we believe this approval is positive news for the emerging field of personalized medicine, and demonstrates the FDA's support for the development and use of these genetic and genomic tests in clinical practice.
However, patients and physicians may now have questions regarding the differences between MammaPrint and Oncotype DX™. With the introduction of any new diagnostic test, it is important for advocates and patients to understand the research that has been conducted to validate that test's reliability and accuracy, as well as to be aware of any limitations that may exist. In particular, you may wish to find out details such as:
- What does the test specifically measure and does it provide individualized information for the patient?
- How will the information gathered from this test benefit patients? What medical decisions will the test results help patients make?
- Can patients and physicians be confident that the test results are both reliable and accurate? Were enough patients’ tumor samples studied in the clinical trials to adequately validate the test’s accuracy?
- What is the profile of the patients who were studied (i.e., age, menopausal status, etc.)? What were the characteristics of their tumors (i.e., lymph node status, stage, etc.)?
- Did the tumor samples that were studied come from patients who received treatment in the community, or were the majority of those samples from patients who were treated through academic centers and institutions? How does this affect the study's results?
- What type of tumor tissue (i.e., blood sample, fresh frozen tissue, or fixed paraffin-embedded tissue) does the test require? Does that type of tissue sample require any special handling and if so, how does that impact physicians' ability to use this test?
- If the test has been cleared by the FDA, what does the label say about that test and what has it been approved to measure? What is it not approved to measure or indicate?
- How familiar are physicians with this test and the data behind it?
- When will this test be available for patients and how much will it cost?
- Will insurers cover the cost of the test? Will the company provide any financial assistance to under- or uninsured patients?
- Will the company provide patients with insurance benefits investigations, denial assistance, and appeals support to limit any financial liability for the cost of the test?
In the case of Oncotype DX, two large-scale clinical studies (NSABP B-14 and Kaiser Permanente) validated the reliability and accuracy of the assay in predicting the risk of distant cancer recurrence (or metastasis) in more than 1,400 patients with estrogen receptor-positive (ER+), lymph node-negative (N-) stage I/II breast cancer. Additionally, several studies were conducted leading up to and after these two pivotal trials, so that Oncotype DX has been evaluated in over 2,600 patients. ER+, N- breast cancer comprises about 50% of all newly diagnosed breast cancer. In other words, Oncotype DX was designed to assist a large portion of the newly diagnosed patient population with understanding their individual risk of recurrence.
The validation studies of Oncotype DX included tumor samples from both pre- and post-menopausal women, and the Kaiser study evaluated Oncotype DX in tumor samples from patients treated in the community setting to make sure that the test had relevance in "real world" situations. Oncotype DX was then studied in another clinical trial (NSABP B-20), which showed that the assay also reliably indicates which ER+, N- early-stage breast cancer patients are most likely to derive benefit from chemotherapy in addition to tamoxifen in the adjuvant setting. With the results of these studies, Oncotype DX has enabled patients and physicians to make more informed decisions and to develop personalized treatment plans based on the patient's individual prognostic and predictive factors.
In addition, of all the patient samples studied by Genomic Health, 99% of them were successfully processed and yielded a Recurrence Score™ from the Oncotype DX assay, indicating that the assay's technology can be performed successfully on almost all patient samples. And because the assay uses formalin-fixed paraffin-embedded tissue (FPET), the technology is easily accessible to institutions, hospitals, and community clinics since FPET is the current standard for preserving tumor tissue.
At Genomic Health we also recognize that new technologies such as Oncotype DX are only helpful to patients if they are accessible to patients. Therefore, we are constantly working to make sure that all patients who are eligible for Oncotype DX are able to actually use the assay. As part of our efforts to ensure patient access, we work closely with insurers across the country to gain reimbursement for Oncotype DX. In the last few months we were pleased to achieve several key milestones towards a favorable reimbursement environment for the assay, including positive coverage decisions by Medicare, Aetna, Cigna, Federal Blue Cross, Humana, HealthNet, United Healthcare, and several other major insurers.
To date, over 24 large payers — representing more than 125,000,000 insured lives — are providing coverage and reimbursement for Oncotype DX. In addition, Genomic Health is currently in active negotiations with another 20 insurers — representing an additional 23,000,000 people — to finalize reimbursement contracts so that Oncotype DX will be covered broadly by healthcare providers.
Genomic Health has created the Genomic Access Program (GAP) to support patients in navigating the insurance process and to provide assistance to un- and underinsured patients. GAP helps patients with benefits investigations and insurance appeals, and also provides financial assistance to qualifying patients to cover the cost of the assay — services which are unprecedented in the laboratory testing industry. For more information on the GAP program, please visit http://www.genomichealth.com/oncotype/about/reimbursement.aspx.
Should you or the patients you serve have further questions or comments about Oncotype DX, we welcome you to contact us with your feedback, and we'd encourage you to engage in similar dialogue with other companies that are developing new genomic tests for cancer patients.
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