Last Updated : April 17, 2024
Details
FilesGeneric Name:
evinacumab
Project Status:
Complete
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).
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | March 16, 2023 |
|---|---|
| Call for patient/clinician input closed | May 09, 2023 |
| Clarification: - Patient input submission received from the Canadian Organization for Rare Disorders and Canadian Heart Patient Alliance | |
| Submission received | May 10, 2023 |
| Submission accepted | May 25, 2023 |
| Review initiated | May 26, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | August 10, 2023 |
| Deadline for sponsors comments | August 21, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | September 15, 2023 |
| Expert committee meeting (initial) | September 27, 2023 |
| Draft recommendation issued to sponsor | October 11, 2023 |
| Draft recommendation posted for stakeholder feedback | October 19, 2023 |
| End of feedback period | November 02, 2023 |
| Clarification: - Reconsideration: minor revisions requested by drug programs - Request for reconsideration accepted | |
| Final recommendation posted | January 31, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 29, 2024 |
| CADTH review report(s) posted | April 17, 2024 |
Files
Last Updated : April 17, 2024