Last Updated : May 23, 2023
Details
FilesGeneric Name:
finerenone
Project Status:
Complete
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
Biosimilar:
No
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.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | April 22, 2022 |
|---|---|
| Call for patient/clinician input closed | June 17, 2022 |
| Clarification: - Patient input submission received from The Kidney Foundation of Canada, Diabetes Canada | |
| Submission received | May 20, 2022 |
| Submission accepted | June 06, 2022 |
| Review initiated | June 07, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | August 30, 2022 |
| Deadline for sponsors comments | September 09, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | October 14, 2022 |
| Expert committee meeting (initial) | October 26, 2022 |
| Draft recommendation issued to sponsor | November 07, 2022 |
| Draft recommendation posted for stakeholder feedback | November 17, 2022 |
| End of feedback period | December 01, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | February 22, 2023 |
| Final recommendation issued to sponsor and drug plans | March 08, 2023 |
| Final recommendation posted | March 27, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 23, 2023 |
| CADTH review report(s) posted | May 18, 2023 |
Files
Last Updated : May 23, 2023