CDA | Evidence Driven
CDA | Evidence Driven

evolocumab

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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
  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 open03-Oct-23
Call for patient/clinician input closed27-Nov-23
Clarification:

- No patient input submission received

Submission received29-Nov-23
Submission accepted13-Dec-23
Review initiated14-Dec-23
Draft CADTH review report(s) provided to sponsor for comment07-Mar-24
Deadline for sponsors comments19-Mar-24
CADTH review report(s) and responses to comments provided to sponsor12-Apr-24
Expert committee meeting (initial)24-Apr-24
Draft recommendation issued to sponsor07-May-24
Draft recommendation posted for stakeholder feedback16-May-24
End of feedback period31-May-24
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration accepted

Final recommendation issued to sponsor and drug plans-
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)-
CADTH review report(s) posted-

Files

Draft Recommendation View PDF
Last Updated : June 17, 2024