Last Updated : April 23, 2024
Details
Generic 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
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
- 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 | October 03, 2023 |
|---|---|
| Call for patient/clinician input closed | November 27, 2023 |
| Clarification: - No patient input submission received | |
| Submission received | November 29, 2023 |
| Submission accepted | December 13, 2023 |
| Review initiated | December 14, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | March 07, 2024 |
| Deadline for sponsors comments | March 19, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | April 12, 2024 |
| Expert committee meeting (initial) | April 24, 2024 |
| Draft recommendation issued to sponsor | May 07, 2024 To May 09, 2024 |
| Draft recommendation posted for stakeholder feedback | May 16, 2024 |
| End of feedback period | May 31, 2024 |
Last Updated : April 23, 2024