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sacubitril/valsartan

Last Updated: March 26, 2021
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).

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Date Recommendation Issued: March 24, 2021

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 open March 30, 2020
Call for patient input closed May 20, 2020
Clarification:

- Patient input submission received from The HeartLife Foundation

Submission received May 22, 2020
Submission accepted June 05, 2020
Review initiated June 08, 2020
Draft CADTH review report(s) provided to sponsor for comment September 02, 2020
Deadline for sponsors comments September 14, 2020
CADTH responses on draft review report(s) provided to sponsor October 08, 2020
Expert committee meeting (initial) October 21, 2020
Draft recommendation issued to sponsor November 04, 2020
End of embargo period December 16, 2020
Clarification:

- Request for extension to embargo period received from sponsor

 

- Embargo extension request granted

 

- Reconsideration requested

Expert committee meeting March 17, 2021
Final recommendation issued to sponsor and drug plans March 24, 2021
Final recommendation posted March 26, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) April 08, 2021
CADTH review report(s) posted