Is CardioMEMS Too Expensive?
The CardioMEMS system has been heralded as a new approach to heart failure, pinpointing worsening congestive heart failure (CHF) earlier to allow physicians to treat patients more effectively. But now, a new review from a non-profit research organization has suggested that CardioMEMS is too costly in light of its clinical benefit.
The CardioMEMS system from St. Jude Medical consists of a small implant placed in the pulmonary artery to monitor pulmonary artery pressure, widely considered to be an indicator of congestive heart failure. The implant’s measurements are transmitted using an electronics system and physicians then have access to the patient’s pressure measurements and trends. Being able to see this data regularly and spot trends earlier allows physicians to modify treatment plans and medications before symptoms set in. The technology was evaluated in the CHAMPION trial before FDA approval in May 2014.A draft report from the Institute for Clinical and Economic Review, prepared for the California Technology Assessment Forum (CTAF), examines CardioMEMS as well as a heart failure drug, Novartis AG’s Entresto. The authors write that they give the CardioMEMS body of evidence an “insufficient” rating because they see many unanswered questions such as mortality impact, usefulness of the technology without vigilant nurse communication, lack of comparison to a strict, rigorous heart failure management regimen, and examination of the technology with only one 550-patient trial. “We believe there is a reasonable chance that CardioMEMS would not confer incremental benefit in all subsequent studies or settings,” the authors write.Beyond ICER’s evaluation of the technology’s body of evidence, the authors go on to note that the $17,750 list price for CardioMEMS is too high, based on cost-effectiveness thresholds and impact on the health care system budget. This assumes that at most, health care expenses should grow 1% fasther than the growth of U.S. gross domestic product (GDP). The analysis finds that “Results for CardioMEMS indicate that the total budgetary impact at one year is similar to the annual average over five years; this is because nearly all CardioMEMS costs are incurred at the time of implantation . . .” The authors note that to stay within the budget impact threshold, “less than 10% of the 450,000 eligibale patients each year could receive CardioMEMS.” The analysis leads to a “value-based price benchmark” of $7,622 for CardioMEMS—what is deemed the appropriate price based on cost-effectiveness and budget impact.