cladribine

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Generic 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
Performance Metric:
Achieved
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 postedNovember 03, 2017
Patient group input closedDecember 22, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJanuary 09, 2018
Patient group comments on input summary closedJanuary 16, 2018
Clarification:

- Patient input summary feedback received

Submission receivedDecember 01, 2017
Submission accepted for reviewDecember 15, 2017
Review initiatedDecember 18, 2017
Draft CDR review report(s) sent to applicantMarch 28, 2018
Comments from applicant on draft CDR review report(s) receivedApril 09, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 16, 2018
Clarification:

- Manufacturer waived the opportunity to request redactions

CDR review team's comments on draft CDR review report(s) sent to applicantMay 04, 2018
Canadian Drug Expert Committee (CDEC) meetingMay 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMay 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJuly 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 agendaOctober 17, 2018
CDEC Final Recommendation issued to applicant and drug plansOctober 24, 2018
CDEC Final Recommendation postedOctober 26, 2018
Final CDR review report(s) and patient input postedOctober 31, 2018