Last Updated : October 10, 2024
Details
FilesGeneric Name:
evolocumab
Project Status:
Active
Therapeutic Area:
Primary hyperlipidemia
Manufacturer:
Amgen Canada Inc.
Call for patient/clinician input open:
Brand Name:
Repatha
Project Line:
Reimbursement Review
Project Number:
SR0821-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Patients with recent acute coronary syndrome (ACS), who have LDL-C 1.8 mmol/L despite optimized lipid-lowering therapy (moderate-to-high intensity statin therapy, with or without ezetimibe).
Submission Type:
Reassessment
Fee Schedule:
Schedule A
Indications:
REPATHA is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia and ASCVD): as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated
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.
| Call for patient/clinician input open | 03-Oct-23 |
|---|---|
| Call for patient/clinician input closed | 27-Nov-23 |
| Clarification: - No patient input submission received | |
| Submission received | 29-Nov-23 |
| Submission accepted | 13-Dec-23 |
| Review initiated | 14-Dec-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 07-Mar-24 |
| Deadline for sponsors comments | 19-Mar-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 12-Apr-24 |
| Expert committee meeting (initial) | 24-Apr-24 |
| Draft recommendation issued to sponsor | 07-May-24 |
| Draft recommendation posted for stakeholder feedback | 16-May-24 |
| End of feedback period | 31-May-24 |
| Clarification: - Reconsideration: minor revisions requested by sponsor - Request for reconsideration accepted | |
| Final recommendation issued to sponsor and drug plans | 08-Aug-24 |
| Final recommendation posted | 26-Aug-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 22-Aug-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : October 10, 2024