Generic Name: ocrelizumab
Brand Name: Ocrevus
Manufacturer: Hoffman-La Roche Limited
Therapeutic Area: Primary progressive multiple sclerosis
Indications: Primary progressive multiple sclerosis
Submission Type: New Indication
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: April 26, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule B
Key Milestones2 | |
---|---|
Call for patient input posted | September 27, 2017 |
Patient group input closed | November 16, 2017 |
Clarification: - Patient input submission received | |
Patient input summary sent for review to patient input groups | November 22, 2017 |
Patient group comments on input summary closed | November 29, 2017 |
Clarification: - Patient input summary feedback received | |
Submission received | October 26, 2017 |
Submission accepted for review | November 09, 2017 |
Review initiated | November 10, 2017 |
Draft CDR review report(s) sent to applicant | February 05, 2018 |
Comments from applicant on draft CDR review report(s) received | February 14, 2018 |
Redaction requests from applicant on draft CDR review report(s) received | February 22, 2018 |
CDR review team's comments on draft CDR review report(s) sent to applicant | March 09, 2018 |
Canadian Drug Expert Committee (CDEC) meeting | March 21, 2018 |
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 05, 2018 |
Embargo period ended and validation of redacted CDR review report(s) received | April 19, 2018 |
CDEC Final Recommendation issued to applicant and drug plans | April 26, 2018 |
CDEC Final Recommendation posted | April 30, 2018 |
Final CDR review report(s) and patient input posted | May 08, 2018 |