Last Updated : March 29, 2021
Details
FilesGeneric Name:
sacubitril/valsartan
Project Status:
Complete
Therapeutic Area:
Heart failure, NYHA Class II or III
Manufacturer:
Novartis Pharma Inc.
Call for patient/clinician input open:
Brand Name:
Entresto
Project Line:
Reimbursement Review
Project Number:
SR0644-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
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:
Reassessment
Fee Schedule:
Schedule B
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.
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 review report(s) and responses to comments provided to sponsor | October 08, 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 | May 17, 2021 |
Files
Last Updated : March 29, 2021