NEW YORK – Two Medicare Administrative Contractors released draft local coverage determinations last week denying a request from Myriad Genetic Laboratories to expand coverage of its EndoPredict breast cancer gene expression test.
The decisions from CGS Administrators and Wisconsin Physicians Service Insurance Corporation came after Myriad submitted additional data published in the journal Clinical Cancer Research and requested expanded access to the test for assessing the benefit of extended endocrine therapy for women with breast cancer, a spokesperson for Myriad said.
The new draft LCDs said the test may help assess risk of late recurrence after endocrine therapy is finished, but it's unclear if the test is useful for identifying patients who should receive extended endocrine therapy (EET). The MACs noted that some of the data presented was not significant for the period studied and added that there's not sufficient evidence the "test can clearly delineate patients who can benefit from EET."
The new LCD doesn't deny coverage for the existing indications for EndoPredict, which have been covered under an LCD since 2017. EndoPredict is covered by Medicare for the management of post-menopausal woman diagnosed with early-stage estrogen receptor positive, Her2-negative breast cancer who are either lymph node-negative or who have one to three positive nodes.
Patients must also be under consideration for treatment with adjuvant endocrine therapy, and the test is used by clinicians to identify patients with sufficiently low risk of distant recurrence at 10 years who can safely forgo chemotherapy.