More patients with breast cancer will benefit from access to its Breast Cancer Index test, under new extended Medicare coverage, Hologic, Inc. has announced. Its’ subsidiary, Biotheranostics, Inc., has received broader Medicare coverage for the test, meaning that clinicians can better manage treatment of a broader scope of patients.
Under the new Medicare criteria, the Breast Cancer Index test is now covered for post-menopausal women diagnosed with early-stage node-positive (one to three axillary lymph nodes), non-relapsed, estrogen receptor (ER) and/or progesterone receptor (PR) positive, HER2 negative breast cancer. This expanded coverage increases the availability of Breast Cancer Index testing with no cost to Medicare beneficiaries who meet the criteria. Previously, Medicare covered the test only for patients with node-negative, non-relapsed, ER and/or PR positive, HER2 negative breast cancer.
“Expansion of Medicare coverage for the Breast Cancer Index test and its recent inclusion in National Comprehensive Cancer Network guidelines are major milestones toward making the test standard of care for all early-stage, HR+ breast cancer patients,” said Kevin Thornal, division president of Diagnostic Solutions at Hologic.
For these patients, the side effects and toxicities of extended endocrine therapy often have significant negative effects on health and quality of life, such as osteoporosis, bone fractures and joint pain. Knowing when extended endocrine therapy will benefit a patient and when it will not, is important in making treatment decisions, and this breakthrough test provides some guidance.
Breast Cancer Index™ is a molecular, gene expression-based test that provides information to help oncologists navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment.
Approximately 85% of early-stage, HR+ breast cancers were node-negative and 15% were node-positive according to data published by the National Cancer Institute in 2021. Based on this data, approximately 25,000 more women every year will be eligible for testing with Breast Cancer Index based on the expanded coverage.