Last Updated : April 20, 2021
Details
FilesGeneric Name:
ofatumumab
Project Status:
Complete
Therapeutic Area:
Multiple Sclerosis, relapsing
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Kesimpta
Project Line:
Reimbursement Review
Project Number:
SR0657-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment
of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient input open | July 27, 2020 |
| Call for patient input closed | September 16, 2020 |
| Clarification:
- Patient input submission received from MS Society of Canada |
|
| Submission received | August 25, 2020 |
| Submission accepted | September 09, 2020 |
| Review initiated | September 10, 2020 |
| Draft CADTH review report(s) provided to sponsor for comment | November 24, 2020 |
| Deadline for sponsors comments | December 03, 2020 |
| CADTH responses on draft review report(s) provided to sponsor | January 08, 2021 |
| Expert committee meeting (initial) | January 20, 2021 |
| Draft recommendation issued to sponsor | February 03, 2021 |
| End of embargo period | February 18, 2021 |
| Final recommendation issued to sponsor and drug plans | February 25, 2021 |
| Final recommendation posted | March 01, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 11, 2021 |
| CADTH review report(s) posted | April 19, 2021 |
Files
Last Updated : April 20, 2021