ICER Draft Report on CardioMEMS and Entresto for Management of Congestive Heart Failure Posted for Public Comment

Boston, Mass. And San Francisco, Calif., September 11, 2015 – The Institute for Clinical and Economic Review (ICER) has released a new report 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 report offers a comprehensive review of currently available evidence on two new interventions that have triggered significant interest as potential advances in the care of patients with congestive heart failure (CHF).  The first of these is a system for monitoring increases in pulmonary artery pressure (a key indicator of worsening CHF) known as CardioMEMS™, 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 health care costs exceeding growth in the overall national economy.

 CHF represents a major public health concern, currently affecting nearly 6 million individuals in the US.  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,” Steven D. Pearson, MD, MSc, the Founder and President of ICER noted.  “The headlines are full of stories about rising health care 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 health care 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, meaning that 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 health care system. In order to keep health care cost growth in line with growth in the national economy, ICER’s value-based price benchmark for Entresto is $3,779 annually, a 17% discount off the list price.  Private insurers and Medicaid programs are frequently able to achieve discounts at this level.


The ICER analysis concludes that the current evidence is “insufficient” to be able to determine that the CardioMEMS HF System 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 health care system. As Dr. 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% discount off the current list price.”

The draft report, as well as accompanying draft voting questions, will be open to public comment until September 25, 2015. Comments should be emailed to ICER will review all comments received and incorporate changes to the report as necessary. A revised draft report and voting questions will be posted on October 8. Guidelines for submitting public comments, including formatting specifications, are posted on the CTAF website.

The revised draft report will be the subject of deliberation and vote at the next meeting of the California Technology Assessment Forum (CTAF) on October 29, 2015 in Oakland, California. During this meeting, the CTAF Panel will publicly deliberate on the evidence presented in the report, vote on the effectiveness and value, and discuss the findings with a policy roundtable of experts to determine strategies to implement evidence-based recommendations that support effective coverage and use of these treatments.  The meeting will be free and open to the public.

There will also a limited number of slots available for anyone wishing to make an oral comment on the report during the in-person meeting. Requests to make an oral comment should be submitted to by Thursday, October 22.

Meeting Details
Date/time: October 29, 2015, 10 am – 4 pm PT
Location: 1111 Broadway, 7th Floor, Oakland, CA 94607
Click here to register to attend the meeting.

Additional explanatory material is available on the ICER website:

New Drug Assessment Project


Value Assessment Project
ICER Rating System Overview [including Evidence-Based Medicine (EBM) matrix]

Drug Assessment Report and Meeting Process Overview
Frequently Asked Questions regarding the drug assessment program