UPDATED Sept. 14, 2015, with comment from St. Jude.
St. Jude Medical (NYSE:STJ)’s CardioMEMS may not be a cost-effective solution for patients with congestive heart failure, according to a study from the non-profit Institute for Clinical and Economic Review in Boston.
The group analyzed the cost effectiveness of St. Jude’s device, which consists of a wireless sensor implanted in the pulmonary artery via catheter to directly measure pressure in the vessel. The device is designed to help physicians manage patients’ medication to control their heart failure before visible changes to weight or blood pressure occur.
In the report, the ICER suggests that the the CardioMEMS has the “potential to provide clinical benefit over standard approaches to CHF management.”
However, when intervention costs and potential savings are evaluated on a population basis, the annual cost of the device “exceeds the potential budget impact threshold at which excessive cost burdens would be placed on the overall health care system,” according to the report.
The group suggests the device, which costs $17,750, has a “value-based price benchmark” of merely $7,622 for treating CHF.
The ICER report also found there to be a “low certainty of a small net benefit” for the system compared to alternatives for managing the disorder, according to the report. The group questioned the device’s impact on mortality and its performance in a setting outside the Champion trial it was tested in.
“We believe there is a reasonable chance that CardioMEMS would not confer incremental benefit in all subsequent studies or settings. Therefore, we judge the current body of evidence to be “insufficient”, or a rating of “I” using the ICER Evidence Rating framework,” the study reports.
“We are confident in the value and benefits demonstrated by the CardioMEMS HF system and are joined by many leading physicians from California and around the country who believe that the technology is a significant breakthrough in the way heart failure patients are managed. CTAF’s draft report encourages review and comments from the public, including real world experience from leading clinicians whose experience with the technology has been favorable and supports outcomes realized through the Champion randomized, controlled and comparative clinical trial,” a spokeswoman for St. Jude told MassDevice.com via email Sept. 14.
In March the company released data from a retrospective look at the Champion trial, saying it helped drive a large reduction in mortality and hospitalization rates for heart failure patients.
St. Jude said the analysis of patients with heart failure and reduced ejection fraction compared the standard of care with and without CardioMEMS monitoring. The review showed that patients monitored using the CardioMEMS device over an average 17 months had a 57% reduction in mortality and a 43% reduction in hospitalizations due to heart failure, compared with patients treated only using the standard of care (optimal doses of guideline-directed medical therapy).