A draft report from a nonprofit that focuses on cost-effectiveness in healthcare takes aim at St. Jude Medical’s CardioMEMS HF System, saying there is insufficient evidence indicating that the device represents a marked improvement over existing technologies.

That was the conclusion of an analysis from the Institute for Clinical and Economic Review, which also found that with a list price of $17,750, CardioMEMS could impose excessive costs on the overall healthcare system. That figure represents the cost of the device itself and not implantation and monitoring.

Indeed, the institute says the device can be priced much lower. “When estimated patterns of CardioMEMS uptake are considered, our value-based price benchmark for CardioMEMS comes in at $7,622, a nearly 60 percent discount off the current list price,” says Steven Pearson, founder and president of ICER, in a prepared statement.

A Breakthrough?

The system is intended for patients with congestive heart failure, a condition that hasn’t seen a major breakthrough treatment in more than a decade, according to the draft document. Currently, about 6 million patients are affected by CHF in the U.S., and the costs for treating the condition are expected to rise.

CardioMEMS is a permanently implanted wireless sensor that measures pulmonary artery pressure, which some studies have shown rises before the signs and symptoms of worsening heart failure. Using the sensor, patients may wirelessly transmit data to a secure online database, that allows treating physicians to access this information. St. Jude acquired the system through its 2014 acquisition of Atlanta-based CardioMEMS.

Despite some reservations, the FDA approved CardioMEMS May 28, 2014. It required the company to conduct two postmarket studies as a condition of the approval — one to assess the device’s safety and effectiveness with a sample size to detect gender differences, and the other to compare post market effectiveness to a subset of premarket recipients.

ICER remains skeptical, even with the FDA’s required studies. “We believe there is a reasonable chance that CardioMEMS would not confer incremental benefit in all subsequent studies or settings,” it says in the draft document. It therefore gives the current body of evidence backing the device an “I” rating for inefficient.

ICER also takes aim at the annual budgetary impact of CardioMEMS utilization, which it calculates to be $1.6 billion annually — well above the organization’s $603 million per year device budgetary impact threshold.

Company Reacts

St. Jude spokeswoman Kate Stoltenberg tells IDDM that the company is confident about the system’s value and benefits, adding that many physicians in California and around the country say it represents a significant breakthrough.

“[The] 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,” she says.

ICER is encouraging public comment on the draft document through Sept. 25, ahead of an Oct. 29 meeting of its California Technology Assessment Forum in Oakland, Calif. That body develops recommendations aimed to improve the quality and value of healthcare. During that meeting, CTAF members will discuss the evidence presented in a revised version of the report and vote on the effectiveness and value of these interventions.

The draft document is available here: www.fdanews.com/092115-St-jude-cardiomems.pdf. — Elizabeth Hollis