ICER Releases Final Report on CardioMEMS HF System™ and Entresto™ for Management of Congestive Heart Failure

Final report includes summary of CTAF’s votes on effectiveness and value, value-based price benchmarks, and key policy recommendations for coverage policy and clinical practice

Contact: Mitchell Stein, 617-528-4013 ext. 7010, mstein@icer-review.org

Boston, Mass., December 1, 2015 – The Institute for Clinical and Economic Review (ICER) has posted the final report CardioMEMS™ HF System (St. Jude Medical, Inc.) and Sacubitril/Valsartan (Entresto™, Novartis AG) for Management of Congestive Heart Failure: Effectiveness, Value, and Value-Based Price Benchmarks and accompanying materials to the California Technology Assessment Forum (CTAF) website. The report evaluates the comparative effectiveness and value of the CardioMEMS device, a system that monitors increases in pulmonary artery pressure (an indicator of worsening congestive heart failure, or CHF), and the drug Entresto, which is a combination of an angiotensin II receptor blocker (ARB) and neprilysin inhibitor. The final report includes the results of the October 29, 2015 public meeting of CTAF, during which an independent panel of experts in evidence voted on key questions raised in the report and a policy roundtable discussed how best to apply the evidence to practice and policy. ICER also released two action guides – one for clinicians, payers, and policymakers, and another for patients. Both are intended to supplement the final report and help stakeholders understand and implement policy based on the evidence on clinical effectiveness and on the value of the interventions examined in the report.

At the meeting, the CTAF panel voted nine to one that Entresto provides greater net health benefits to patients than standard care with angiotensin converting enzyme (ACE) inhibitors. A majority of the panel also voted that CardioMEMS improves net health benefits compared to usual care and monitoring, though the votes were closely split, with six of the ten panelists judging the current evidence to be adequate to conclusively state that the device produces improved health outcomes and four judging the evidence to be inadequate.

The panel also considered economic analyses of the long-term cost effectiveness and short-term budget impact associated with the adoption of the two interventions in votes on care value and provisional health system value. A majority of panel members found Entresto to provide intermediate care value, a measure representing long-term benefit to patients, based on the combination of its clinical- and cost-effectiveness. However, a majority voted that the drug provides low provisional health system value due to the large potential budget impact resulting from the higher costs relative to ACE inhibitors combined with the large number of patients who would be eligible for treatment. ICER’s analysis found that to prevent an excessive cost burden on the health care system, the price of Entresto would have to be discounted from its wholesale acquisition cost of $4,560 to $4,168, a discount of 9%. Private insurers and Medicaid programs are frequently able to achieve discounts of this magnitude.

A majority of panel members judged that CardioMEMS represents low care value as a result of uncertainties over the magnitude of benefit provided by the device. In addition, a majority of panel members voted that the device represented low provisional health system value based on concerns that unmanaged uptake of the device would exceed the threshold established in the ICER Value Assessment Framework. ICER’s value-based price benchmark for CardioMEMS is $10,665, a 40% discount from the Medicare list price of $17,750.

Among the key recommendations for coverage policy and clinical practice arising from the discussion, votes, and subsequent policy debate were the following:

  1. Provider groups and payers should consider limiting prescribing of Entresto to cardiologists or require other clinicians to consult with cardiologists due to potential side effects, the importance of selecting appropriate patients for therapy, and the large cost of Entresto compared to ACE inhibitors or ARBs.
  2. Based on the combination of clinical benefit to patients, pricing aligned with patient benefit, and short-term affordability, payers and purchasers should consider placing Entresto in the “preferred brand” category of their formulary, especially if they are able to reach ICER’s value-based price benchmark through negotiations.
  3. Within labeled indications, the greatest potential for benefit from the CardioMEMS system is for patients 1) whose disease course has been relatively unstable while on optimal medication regimens and who have had more than one hospitalization in a relatively short period of time, and 2) who are committed to engage with providers and participate in the interactions required to gather and act upon the information provided by CardioMEMS.
  4. Provider groups that offer the CardioMEMS system should consider implementing it through a Center of Excellence model that ensures appropriate resources are dedicated to supporting patients with the device.
    A full summary of the key policy recommendations is available in the final report.

About CTAF
The California Technology Assessment Forum (CTAF) – a core program of the Institute for Clinical and Economic Review (ICER) – reviews objective evidence reports and holds public meetings to develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about CTAF, please visit www.ctaf.org.

About ICER
The Institute for Clinical and Economic Review (ICER) is an independent non-profit health care research organization dedicated to improving the interpretation and application of evidence in the health care system. ICER directs three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). For more information about ICER, please visit ICER’s website, www.icer-review.org.