Last Updated : November 9, 2023
Details
FilesGeneric 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).
- 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 | 16-Mar-23 |
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Call for patient/clinician input closed | 09-May-23 |
Clarification: - Patient input submission received from the Canadian Organization for Rare Disorders and Canadian Heart Patient Alliance | |
Submission received | 10-May-23 |
Submission accepted | 25-May-23 |
Review initiated | 26-May-23 |
Draft CADTH review report(s) provided to sponsor for comment | 10-Aug-23 |
Deadline for sponsors comments | 21-Aug-23 |
CADTH review report(s) and responses to comments provided to sponsor | 15-Sep-23 |
Expert committee meeting (initial) | 27-Sep-23 |
Draft recommendation issued to sponsor | 11-Oct-23 |
Draft recommendation posted for stakeholder feedback | 19-Oct-23 |
End of feedback period | 02-Nov-23 |
Clarification: - Reconsideration: minor revisions requested by drug programs - Request for reconsideration accepted |
Files
Last Updated : November 9, 2023