The Institute for Clinical and Economic Review (ICER) has released the revised draft report CardioMEMS™ HF System (St. Jude Medical) and Sacubitril/Valsartan (Entresto™, Novartis) for Management of Congestive Heart Failure: Effectiveness, Value, and Value-Based Price Benchmarks that reflects revisions made following a public comment period. The revised draft includes 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.
ICER is committed to a transparent public engagement process to ensure that all stakeholders have the opportunity to provide input to our evidence reports. After the initial draft ICER report was released, drug and device manufacturers, as well as other stakeholders, had a two week period to provide comments. These comments have been considered by ICER staff as part of the development of a revised draft report that will be used to support deliberations and voting at the October 29, 2015 meeting of the California Technology Assessment Forum (CTAF).
More information on our methods for public engagement can be found here: Drug Assessment and Meeting Overview.
Based on comments received, the revised draft contains additional information and updates to several analyses. You can read a detailed description of our response to comments, including the impact those comments had on the revision of the draft report, here. You can access the revised draft report , as well as revised voting questions and public comments received, here.
A limited number of seats are still available for members of the public who wish to attend the CTAF meeting that will be held in Oakland on October 29, 2015. Members of the public may register by clicking here; those unable to attend the meeting in-person may register for a live webcast of the event by clicking here. A video recording will be available on the website after the meeting.