Upcoming Medicare decision threatens coverage of cancer test

Medicare is considering discontinuing coverage of circulating tumor cell (CTC) assays for beneficiaries across West Virginia, Virginia, North Carolina, and South Carolina.

CTC assays predict progression-free survival and overall survival, and monitor treatment response in metastatic breast, colorectal, and prostate cancers. CTCs are tumor cells that have detached from solid tumors and entered the patient’s bloodstream. The number of CTCs in patients with metastatic breast, prostate, or colorectal cancer can predict favorable or unfavorable prognosis at initiation of and over the course of treatment.

The pending Non-Coverage Decision (DL34631, Circulating Tumor Cell Marker Assays) includes, but is not limited to CELLSEARCH (Janssen Diagnostics), OncoCEE-BR (Biocept), and real-time polymerase chain reaction, or PCR (RT-PCR), assays (e.g., TaqMan, Life Technologies), which are used to amplify and simultaneously quantify a targeted DNA molecule.

“[The CTC test] enables doctors to detect changes in their patients’ status and provides information about their prognosis, thereby helping physicians make more informed patient-care decisions,” says Jorge Villacian, MD, Chief Medical Officer, Janssen Diagnostics, makers of CELLSEARCH, the first and only FDA-approved CTC test. It detects, captures, and enumerates CTCs with a high level of sensitivity and specificity.

“Importantly, in certain clinical contexts-for example in prostate, breast, and colorectal cancer with bone-only metastasis-CTC testing may be of increased value to patients when other parameters like imaging are not applicable,” Dr. Villacian says.

To date, 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. From 2010 to 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.

Janssen Diagnostics sells the CELLSEARCH system and reagents to labs, which, in turn, offer the test to oncologists and their patients. This means that the final cost is influenced by each labs’ pricing system. In general, the test costs $450 to $600 in the United States. 

“The potential to switch from an ineffective therapy-certainly more costly than the test itself-underscores the value of the test,” says Dr. Villacian.