The implantable CardioMEMS heart failure monitor can be cost-effective if it remains durable over a long period of time and is used in the right patients, a study suggested.
The pulmonary artery pressure sensor was tied to fewer lifetime hospitalizations (from 3.12 to 2.18) and more quality-adjusted life years (QALYs, from 2.46 to 2.74) for heart failure patients, according to a model based on data from the CHAMPION and CHARM trials.
Action Points
- The implantable CardioMEMS heart failure monitor can be cost-effective if it remains durable over a long period of time and is used in the right patients.
- Note that the study suggest that alhough it is a costly intervention, the value of this device compares favorably to other technologies used in similar patient groups, such as left-ventricular assist devices.
But with a $17,750 price under Medicare, CardioMEMS increased overall costs of care from $156,569 to $176,648, translating to , found , of California's VA Palo Alto Health Care System, and colleagues.
CardioMEMS cost $47,768 per QALY in patients with preserved ejection fraction, due to a longer expected survival. That figure ballooned to $82,301 in the reduced ejection fraction subgroup.
"Our analysis indicates that the CardioMEMS device provides better value in patients with preserved ejection fraction," the researchers reported in the February issue of , adding that the device "represents a rare evidence-supported intervention for this important group."
"Although it is a costly intervention that should be reserved for appropriately selected patients and still requires further evaluation, the value of this device compares favorably to other technologies used in similar patient groups, such as left-ventricular assist devices," the authors concluded.
A prior independent analysis by the nonprofit Institute for Clinical and Economic Review had estimated a cost per QALY of about $58,000 for the device, which it called "excessive" given "insufficient" evidence for overall patient outcome improvement.
However, , of SUNY Downstate Medical Center in Brooklyn, sided with Sandhu's group on a more favorable interpretation.
Approximately 80% of the cost of managing a patient with heart failure is attributable to heart failure hospitalizations, he told MedPage Today.
"The reduction in hospitalizations with the CardioMEMS device ultimately should lead to cost reductions relative to the benefits of using the device. Indeed, ultimately the reduction in hospitalizations may be sufficient to overcome the initial cost of the CardioMEMS device," he suggested.
The take-home message for clinicians is that "monitoring pulmonary artery pressure with the CardioMEMS provides clear benefits that justify the costs," Borer agreed.
Sandhu's study found that a $190 monthly fee for the CardioMEMS would limit costs per QALY to $100,000. Additionally, CardioMEMS must last over 34 months in order to cost less than $150,000 for every QALY.
, of The Ohio State University in Columbus, told Ƶ that "given the durability of this sensor, which appears to be in excess of ten years, the return on investment may be even larger over time."
The authors noted that the device would need to reduce mortality by 4% in order for it to cost less than $100,000 per QALY, but "while this seems likely, it is possible that prevented hospitalizations may be lower risk and mortality may be relatively unaffected."
Thus "it is unclear how preventing hospitalizations with CardioMEMS affects survival," Sandhu's group admitted, with the device's long-term effectiveness unknown.
The lack of long-term safety data, along with their reliance on a model that may not have captured all the potential benefits of the CardioMEMS, counted among the limitations of their study, the authors added.
The CardioMEMS received FDA approval in 2014, following a panel vote in 2013. The device relates pressure and heart rate information to health providers, who access it through a database.
"It is important to assess the cost-effectiveness of new therapies and new monitoring devices because a great deal of that cost will be borne by society through taxation and Medicare and other government sponsored health insurance programs," emphasized Borer, who served on two FDA advisory panels that evaluated the device.
In the case of CardioMEMS, "which is FDA approved and now shown to be cost-effective, should be strongly considered for indicated patients -- those with NYHA Class III heart failure, regardless of ejection fraction, and a history of at least one heart failure hospitalization in the past 12 months," concluded Abraham, who was a principal investigator of the CHAMPION trial.
Disclosures
Sandhu and Borer reported no relevant conflicts of interest.
Abraham disclosed receiving consulting fees from CardioMems and St. Jude Medical.
Primary Source
JACC Heart Failure
Sandhu AT, et al "Cost-effectiveness of implantable pulmonary artery pressure monitoring in chronic heart failure" JCHF 2016; DOI: 10.1016/j.jchf.2015.12.015.