Last Updated : December 21, 2018
Details
FilesGeneric Name:
cladribine
Project Status:
Complete
Therapeutic Area:
Multiple Sclerosis, relapsing-remitting
Manufacturer:
EMD Serono, a Division of EMD Inc., Canada
Brand Name:
Mavenclad
Project Line:
Reimbursement Review
Project Number:
SR0546-000
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Multiple Sclerosis, relapsing
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones2 | |
|---|---|
| Call for patient input posted | November 03, 2017 |
| Patient group input closed | December 22, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | January 09, 2018 |
| Patient group comments on input summary closed | January 16, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | December 01, 2017 |
| Submission accepted for review | December 15, 2017 |
| Review initiated | December 18, 2017 |
| Draft CDR review report(s) sent to applicant | March 28, 2018 |
| Comments from applicant on draft CDR review report(s) received | April 09, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | April 16, 2018 |
| Clarification: - Manufacturer waived the opportunity to request redactions | |
| CDR review team's comments on draft CDR review report(s) sent to applicant | May 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | May 16, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | May 30, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | July 12, 2018 |
| Clarification: - Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested | |
| Applicant's request for reconsideration placed on CDEC agenda | October 17, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | October 24, 2018 |
| CDEC Final Recommendation posted | October 26, 2018 |
| Final CDR review report(s) and patient input posted | October 31, 2018 |
Files
Last Updated : December 21, 2018