finerenone


( Last Updated : December 1, 2022)
Generic Name:
finerenone
Project Status:
Active
Therapeutic Area:
Chronic kidney disease
Manufacturer:
Bayer Inc.
Brand Name:
Kerendia
Project Line:
Reimbursement Review
Project Number:
SR0737-000
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Bayer requests that finerenone 10 mg, and 20 mg be reimbursed as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of: End-stage kidney disease and a sustained decrease in estimated glomerular filtration rate, Cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure. Standard of care includes: an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), and a sodium-glucose cotransporter-2 inhibitor (SGLT2i), unless contraindicated or not tolerated
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Kerendia (finerenone) is indicated as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of: • End-stage kidney disease and a sustained decrease in estimated glomerular filtration rate,• Cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure.
  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/clinician input openApril 22, 2022
Call for patient/clinician input closedJune 17, 2022
Clarification:

- Patient input submission received from The Kidney Foundation of Canada, Diabetes Canada

Submission receivedMay 20, 2022
Submission acceptedJune 06, 2022
Review initiatedJune 07, 2022
Draft CADTH review report(s) provided to sponsor for commentAugust 30, 2022
Deadline for sponsors commentsSeptember 09, 2022
CADTH review report(s) and responses to comments provided to sponsorOctober 14, 2022
Expert committee meeting (initial)October 26, 2022
Draft recommendation issued to sponsorNovember 07, 2022
Draft recommendation posted for stakeholder feedbackNovember 17, 2022
End of feedback periodDecember 01, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor