CADTH | Evidence Driven
CADTH | Evidence Driven

evinacumab

Details

Files
Generic Name:
evinacumab
Project Status:
Active
Therapeutic Area:
Homozygous familial hypercholesterolemia (HoFH)
Manufacturer:
Ultragenyx Pharmaceutical Inc.
Call for patient/clinician input open:
Brand Name:
Evkeeza
Project Line:
Reimbursement Review
Project Number:
SR0778-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ultragenyx is requesting evinacumab be reimbursed as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients aged 5 years and older with homozygous familial hypercholesterolemia (HoFH).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
evinacumab is indicated as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients aged 5 years and older with homozygous familial hypercholesterolemia (HoFH).
  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 open16-Mar-23
Call for patient/clinician input closed09-May-23
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders and Canadian Heart Patient Alliance

Submission received10-May-23
Submission accepted25-May-23
Review initiated26-May-23
Draft CADTH review report(s) provided to sponsor for comment10-Aug-23
Deadline for sponsors comments21-Aug-23
CADTH review report(s) and responses to comments provided to sponsor15-Sep-23
Expert committee meeting (initial)27-Sep-23
Draft recommendation issued to sponsor11-Oct-23
Draft recommendation posted for stakeholder feedback19-Oct-23
End of feedback period02-Nov-23
Clarification:

- Reconsideration: minor revisions requested by drug programs

- Request for reconsideration accepted

Files

Draft Recommendation View PDF
Last Updated : November 9, 2023