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BioTheranostics Gets Medicare Coverage for Breast Cancer Index Test

NEW YORK (GenomeWeb) – BioTheranostics today said that it has received a positive coverage and reimbursement evaluation from a Medicare contractor for its Breast Cancer Index test.

Palmetto GBA, the Medicare administrator responsible for the MolDx molecular diagnostic technology assessment program, made the determination and the US Centers for Medicare and Medicaid Services posted the policy, according to the San Diego-based firm. BioTheranostics didn't disclose CMS pricing for the test.

The Breast Cancer Index is a gene expression test that assesses a woman's risk of early breast cancer recurrence in the first five years following diagnosis, late recurrence beyond five years post-diagnosis, and overall 10-year risk. It algorithmically combines molecular grade index, which factors in information about tumor grade and proliferation status, and the so-called HOXB13:IL17BR ratio, which characterizes estrogen signaling pathways.

BioTheranostics said that the Medicare policy covers the use of the BCI to predict risk of late (5-10 years) distant recurrence in women with early stage, estrogen receptor-positive breast cancer who are considering extended therapy but are concerned about continuing anti-hormonal therapy because of documented toxicity or possible significant patient-specific side effects.

"We are pleased that we have attained such a significant milestone within the first eight months of full commercialization of the Breast Cancer Index — the only molecular test covered by Medicare that accurately assesses a patient's individualized risk of breast cancer recurrence after five years and is validated to identify which patients will benefit from extended hormone therapy," Nicolas Barthelemy, who recently joined BioTheranostics as president and CEO, said in a statement. "This critical information will allow many women to avoid unnecessary treatment and potential side effects that can adversely affect their health and quality of life."

BioTheranostics' BCI test was one of three molecular tests that were part of draft local coverage determinations issued by Palmetto earlier this year stipulating reimbursement criteria for the tests.

As reported by Pharmacogenomics Reporter in July, the draft LCD, granted in Palmetto's North Carolina jurisdiction, limited coverage of BCI for post-menopausal women with ER-positive breast cancer; for a patient who is completing five years of tamoxifen treatment; when the doctor or patient is concerned about toxicities related to anti-hormonal therapy; and when test results, the risk and benefits of testing, and treatment guidelines are discussed with the patient. Palmetto also warned at the time that BCI cannot be used by itself, and that doctors must consider patients' clinical factors when gauging their recurrence risk after five years.

That LCD was followed last month by a cost-effective analysis of the BCI published in the The American Journal of Managed Care showing that the molecular diagnostic test lowers healthcare spending in women with estrogen-receptor positive disease when used at the time of diagnosis or five years after diagnosis.