CardioMEMS image courtesy of St. Jude Medical.
September 16, 2015 — The Institute for Clinical and Economic Review (ICER) has released a new report offering a comprehensive review of currently available evidence on two new interventions as potential advances in the care of congestive heart failure (CHF) patients. The report is titled CardioMEMS HF System (St. Jude Medical) and Sacubitril/Valsartan (Entresto, Novartis) for Management of Congestive Heart Failure: Effectiveness, Value, and Value-Based Price Benchmarks.
The first system discussed, known as CardioMEMS, monitors increases in pulmonary artery pressure (a key indicator of worsening CHF) , and the second is the medication sacubitril/valsartan (Entresto) to treat CHF. The ICER report provides analyses of long-term cost-effectiveness and the potential budget impact of these new interventions. In addition, the results of these analyses are used to calculate a value-based price benchmark for each intervention. These price benchmarks reflect estimates of how much better the interventions are at improving patient outcomes, tempered by thresholds at which additional new costs would contribute to growth in healthcare costs exceeding growth in the overall national economy.
CHF represents a major public health concern, currently affecting nearly 6 million individuals in the United States. Growth in per capita medical spending and aging of the population are expected to contribute to substantial increases in the direct medical costs of treating CHF, with annual costs totaling nearly $80 billion by 2030.
"Figuring out the effectiveness and value of new drugs and devices is not merely an academic exercise," noted Steven D. Pearson, M.D., MSc, founder and president of ICER. "The headlines are full of stories about rising healthcare costs and their impact on patients, families, and the budgets of states and the federal government. A clear-eyed view of the evidence is critical to all members of the healthcare community as we try to figure out what should be used, which patients benefit most and at what price innovative treatments represent a reasonable value."
ICER's analysis concludes that there is moderate certainty that Entresto provides a small to substantial net health benefit compared to the current standard of care in patients with CHF. Entresto increases the average length of life for patients and also decreases the number of hospitalizations for CHF. At the list price of $4,560 per year, Entresto does not save money over the long term but its added costs are well-aligned with the degree of benefit it brings to patients. This means Entresto can be judged "cost-effective" in the long term according to commonly accepted cost-effectiveness thresholds.
However, ICER's analysis predicts that nearly 2 million patients could be prescribed Entresto over the first five years, creating a total budget impact so high that excessive cost burdens would be placed on the overall healthcare system. In order to keep healthcare cost growth in line with growth in the national economy, ICER's value-based price benchmark for Entresto is $3,779 annually, a 17 percent discount off the list price. Private insurers and Medicaid programs are frequently able to achieve discounts at this level.
Regarding the CardioMEMS HF System, the ICER analysis concludes that the current evidence is "insufficient" to be able to determine that it improves overall patient outcomes. If the device is used, however, at a list price of $17,750, it would also exceed the threshold for potential budget impact that indicates an excessive cost to the overall healthcare system. As Pearson noted, "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."
The draft report, as well as accompanying draft voting questions, will be open to public comment until Sept. 25, 2015.
For more information: www.icer-review.org
January 27, 2026 
