The OBR Blog

February 20, 2014 - 08:02 am Posted in Featured comments0 Comments

If Palmetto GBA gets their way, oncologists and cancer patients in West Virginia, Virginia, and North and South Carolina may soon be denied access to Janssen Diagnostics’ CELLSEARCH® CTC test, indicated for use in patients with metastatic breast, colorectal, or prostate cancer.

The test is used to capture and count circulating tumor cells (CTC) in patients; and in conjunction with all other clinical information collected from a physical examination, a complete medical history, and results from diagnostic tests (e.g. blood, imaging, and/or laboratory tests), a more complete picture to determine a patient’s prognosis can be assessed.

Does Medicare coverage or lack of coverage impact quality cancer care? Well, if you’re unlucky enough to live in one of these 4 states, you need to know that Medicare is considering discontinuing coverage for the CTC test in your region. The pending Non-Coverage Decision (DL34631, Circulating Tumor Cell Marker Assays) for the test is to be decided on February 24, 2014. While this isn’t a life or death situation, it would be nice to think that eligible patients could get access to technology without having to pay out of pocket. Or at least coverage wouldn’t depend on where your house is.

The CELLSEARCH CTC test, initially cleared by the FDA in 2004, is the only in vitro diagnostic (IVD) test that has been cleared through the FDA 510(k) review process.

According to Andrew J. Armstrong, MD, Duke Cancer Center, men with metastatic prostate cancer have a wide range of outcomes that can range from months to many years of life expectancy.

The CELLSEARCH CTC test is able to provide a more refined prognosis when used in combination with other tests, “and the number of CTCs in the blood at any given time can lead to adjustments in prognosis during therapies with chemotherapy or newer hormonal therapies,” he said.

“There are some men whose prostate cancers do not produce much PSA, and some men where the CTC test really adds clinical value in the decision to stop an ineffective therapy or continue an effective one.”

The clinical validity of CTC enumeration tests is well-established in scientific literature, including articles published in respected journals, such the New England Journal of Medicine, Journal of Clinical Oncology, Lancet Oncology, Urology and many other peer-reviewed, highly regarded journals.

Clinical data from 26 independent prospective studies involving more than 2,800 patients have been published in more than 100 peer-reviewed publications that validate the clinical performance and value of the test.

On the other hand, we spoke to Dean Gesme, MD, a medical oncologist at Minnesota Oncology, and he told us, “We don’t utilize the test in our practice.  The technology is fascinating but its role in determining treatment or in informing the need for changes of therapy have yet to be validated.”

“While more studies are needed to understand how to use the CTC to guide therapy decisions, the value that the CTC test provides currently is similar or better than the value that PSA tests, CT scans, and bone scans provide to doctors and patients in the clinic,” Dr. Armstrong went on to say.

Oncologists and patients are concerned that the draft non-coverage decision, if finalized in its current form, could jeopardize Medicare beneficiary access to the CELLSEARCH® CTC test and consequently impact clinical management of beneficiaries with certain types of metastatic cancer.

According to a statement from the company, “For patients undergoing cancer treatment, CTC testing provides data on whether their prognosis is changing over time. This allows physicians to make an evidence-based decision regarding whether to continue existing therapy, change therapy, and/or stop therapy. Thus by providing physicians with earlier disease prognosis data, patients can be spared prolonged periods of treatment with ineffective therapy and its cumulative toxicities, and alternative active therapies can be initiated, or options such as hospice care can be contemplated.”

Janssen Diagnostics is seeking to continue constructive discussions with Palmetto (the regional Medicare carrier) to review data published in peer-reviewed medical journals and presented at major medical meetings that confirm the value of CTC testing.

From 2010-2012 alone, more than 85,000 U.S. patients and their oncologists used CELLSEARCH® to better understand the progression of disease and make more informed treatment decisions.

To submit your concerns directly to Medicare about the pending Non-Coverage Decision test, you can go to:

by John McCleery

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