Test Predicts Benefit of Extended Endocrine Therapy in Breast Cancer Patients

bioTheranostics, Inc’s Breast Cancer Index, a genomic test quantifying the risk of breast cancer recurrence and predicting which patients will likely benefit from extended endocrine therapy, will be covered by Medicare.

The CMS policy will cover use of the test to predict risk of late recurrence in women with early state, estrogen receptor-positive breast cancer, who are concerned about continuing anti-hormonal therapy. The coverage and payment will even be made retrospectively for previously submitted claims, according to bioTheranostics.

“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,” Nicolas Barthelemy, president and chief executive officer of bioTheranostics, said in a statement. “We appreciate Palmetto GBA’s consideration and diligence in reaching this coverage decision.”

The Breast Cancer Index is currently the only molecular test covered by Medicare that assess an individual patient’s risk of breast cancer recurrence after 5 years, Mr Barthelemy added.

ASCO recently updated its guidelines to encourage consideration of extended endocrine treatment in some breast cancer patients beyond 5 years. However, some women considering extended therapy are concerned about documented toxicity or possible patient-specific side effects.

“Women with breast cancer face difficult tradeoffs between wanting to take steps to help prevent the recurrence of their disease and facing significant side effects and costs related to extended endocrine treatments,” Ruth O’Regan, MD, MRCPI, director of translational breast cancer research at the Winship Cancer Institute of Emory University. “The Breast Cancer Index provides important, patient-specific genomic information that helps clinicians identify patients who may not benefit from extended endocrine treatments, allowing them the choice of discontinuing therapy.”