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Last Updated: December 16, 2020
Result type: Reports
Project Number: SR0644-000
Product Line: Reimbursement Review

Generic Name: sacubitril/valsartan

Brand Name: Entresto

Manufacturer: Novartis Pharma Inc.

Therapeutic Area: Heart failure, NYHA Class II or III

Indications: Entresto is indicated for the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with NYHA Class II or III, to reduce the incidence of cardiovascular death and heart failure hospitalisation. Entresto should be administered in combination with other heart failure therapies, in place of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB). Entresto should be initiated, and up-titration conducted, by a physician experienced with the treatment of heart failure.

Manufacturer Requested Reimbursement Criteria1: Addition to the current criteria: Initiation of sacubitril/valsartan may be considered in patients stabilized from a heart failure hospitalization without prior exposure to angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB).

Submission Type: Array

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule B

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input openMarch 30, 2020
Call for patient input closedMay 20, 2020

- Patient input submission received from The HeartLife Foundation

Submission receivedMay 22, 2020
Submission acceptedJune 05, 2020
Review initiatedJune 08, 2020
Draft CADTH review report(s) provided to sponsor for commentSeptember 02, 2020
Deadline for sponsors commentsSeptember 14, 2020
CADTH responses on draft review report(s) provided to sponsorOctober 08, 2020
Expert committee meeting (initial)October 21, 2020
Draft recommendation issued to sponsorNovember 04, 2020
End of embargo periodDecember 16, 2020

- Request for extension to embargo period received from sponsor

- Embargo extension request granted

- Reconsideration requested

Expert committee meetingMarch 17, 2021