Patients with heart failure may benefit from treatment with the CardioMEMS device, a miniaturized implantable system that monitors pulmonary artery pressures. However, a recent analysis found that the evidence was lacking because of potential confounders.

The device may be cost-effective based on accepted thresholds but only if payers are able to negotiate a 40-percent discount from what CMS pays for the device.

Lead researcher Daniel A. Ollendorf, PhD, of the Institute for Clinical and Economic Review (ICER) in Boston, and colleagues published their results online in JAMA Internal Medicine on Sept. 6. ICER is a nonprofit healthcare research organization.

For this analysis, the researchers evaluated the CHAMPION trial, which enrolled 550 patients with New York Heart Association class III heart failure who were hospitalized for heart failure within the past 12 months. All patients were implanted with St. Jude Medical’s CardioMEMS device, which the FDA approved in May 2014. Clinicians received pulmonary artery pressure readings from the treatment group, but they did not receive readings from the control group.

After six and 15 months of follow-up, patients in the treatment group had significantly fewer heart failure-related hospitalizations. After 18 months, 50 patients in the treatment group and 64 patients in the control group died. The difference was not statistically significant.

The researchers based their cost-effectiveness estimates on the costs that CMS pays for the CardioMEMS device, including $17,750 for the device, $1,129 for the implantation procedure and $27 per month for monitoring the remotely transmitted data.

The cost per quality-adjusted life year (QALY) was $57,933 for the CardioMEMS device. The researchers mentioned that the cost-effectiveness would exceed $100,000 per QALY gained if the benefits of the CardioMEMS persisted for 4.6 years or less or if the cost of the device doubled.

They also estimated that 25 percent of patients who were eligible for the CardioMEMS device would receive it at the end of five years. During those five years, they said the potential budget impact for payers would be approximately $5 billion. They added that the five-year budget impact would be reasonable if the CardioMEMS device cost $10,665, which is 40 percent lower than the price CMS pays.

Based on the researchers’ findings, the California Technology Assessment Forum voted 6 to 4 in favor of the CardioMEMS device having an incremental net health benefit. The California Technology Assessment Forum is a program of ICER’s and is supported by grants from the Blue Shield of California Foundation, the California Health Care Foundation and the Laura and John Arnold Foundation.

However, seven of nine panelists said the CardioMEMS device was of low value because of uncertainty about its clinical benefit and its high costs. The researchers noted that a roundtable discussion after the vote led to a recommendation that physicians choose patients carefully before treating them with the CardioMEMS device. The panel also suggested that the device should prioritized for patients with class III heart failure who are comfortable with frequent interactions about their pulmonary artery pressure and who have had unstable disease despite taking optimal medications.