A panel of Medicare advisers will review evidence of how well certain tests work in helping doctors gauge the progress of lung, breast and colon cancer and what help these diagnostics can provide in choosing treatments.
A March 24 meeting of the Medicare Evidence Development and Coverage Advisory Committee has been scheduled to look at products that are meant to pick up on genetic variations produced in cancer cells.
Medicare is seeking the opinions of its advisers on about whether such tests can help patients live longer as a result of better treatment decisions and avoid complications from certain chemotherapies.
A report released last year raised questions about the ultimate benefits of some of the tests.
Doctors rely on the products in shaping discussions with patients about whether their prognosis is better or worse than average, according to the report from the Agency for Healthcare Research and Quality. Much of the available evidence focuses on determining prognosis, but there’s been little emphasis on how the information may affect the outcomes of treatment for patients, such as with the selection of medicines, the report stated.
“Such changes in management may be occurring and may be of benefit, or possibly harm, to patients, but they have not been measured and studied, with the notable exception of the Oncotype DX assay in breast cancer,” the authors wrote.
They added that there is “a sizeable body of evidence” to suggest Oncotype DX results in fewer recommendations for chemotherapy, and thus less exposure for some patients to the harms of this treatment, but noted that there are still questions about the effect on this test on outcomes for patients.
The deliberations of MedCAC panels are meant to aid the Centers for Medicare and Medicaid Services in setting payment policies, but are not binding. At the March meeting, the advisers’ discussion is intended to help CMS shape decisions “about the extent to which it may wish to use existing evidence as the basis for any future determinations about coverage for tests that estimate cancer prognosis.”
As part of the discussion, Medicare intends to have this expert panel weigh in on one of the liveliest current topics in the arena of diagnostics.
Among the questions to be considered by the panel is whether the regulatory status of a test should count in considering evidence of how it will work. The Food and Drug Administration last year kicked off what promises to be lengthy tussle with academic health centers and companies that make diagnostic products, by officially unveiling a new framework for regulating certain tests used in cutting-edge medicine.
The FDA is reconsidering what had long been a hands-off approach to lab-developed tests. Decades ago, lab-developed tests often were used by doctors and pathologists working in a single medical center. But advances in genetics have blurred the distinction between the lab-developed tests and other diagnostics. Many large companies now market medical tests nationwide and even globally without getting FDA clearance.
The Oncotype DX diagnostics from Genomic Health, for example, are considered lab-developed tests. Redwood City, California-based Genomic Health calls these a service, through which its laboratory provides through an analysis of the genes expressed in certain tumors. The company has agreements with distributors in more than 90 countries, and reported product revenue of $206.6 million for the nine months ended in September 2014.