The California Technology Assessment Forum (CTAF), a core program of the Institute for Clinical and Economic Review (ICER), will hold a public meeting on Thursday, October 29, 2015 to discuss the comparative effectiveness and value of two interventions for patients with congestive heart failure (CHF) – the investigational drug LCZ696 and the CardioMEMS™ HF System. The CardioMEMS HF System is a pulmonary artery pressure monitor manufactured by St. Jude Medical and approved by the FDA in May 2014. LCZ696 is manufactured by Novartis and is a combination of the company’s angiotensin receptor inhibitor valsartan (Diovan®) and a novel neprilysin inhibitor (sacubitiril). The drug was granted FDA priority review in February 2015, with a decision on approval expected as early as August 2015. The CTAF panel will review these interventions given the magnitude of their potential clinical and economic impact on the care of patients with CHF.
ICER will produce a report that includes a systematic review of the published evidence, as well as an economic analysis featuring these two interventions. The report will also feature a calculation of a “value-based price benchmark” for the interventions under review. This price benchmark will be based on an analysis of comparative cost-effectiveness relative to the current standard of care and the potential short-term budgetary impact for health systems. The report will form the basis for deliberation and discussion at the public meeting, where the CTAF Panel will vote on key questions raised in the report, and a policy roundtable will discuss evidence-based practice and policy recommendations.
A preliminary scoping document will be posted on the CTAF website for public comment on or about July 9, 2015. After the scoping document is posted, stakeholders will have one week to submit suggestions and refinements to ensure that the report provides a comprehensive analysis of the California-specific considerations and issues of greatest importance. For a full timeline of key dates for the review, click here.
Date: October 29, 1015
Meeting details and registration information will be posted to to the CTAF website as they become available.