Generic Name: ocrelizumab
Brand Name: Ocrevus
Manufacturer: Hoffman-La Roche Limited
Therapeutic Area: multiple sclerosis, relapsing
Indications: multiple sclerosis, relapsing
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: November 21, 2017
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Key Milestones2 | |
|---|---|
| Call for patient input posted3 | April 18, 2017 |
| Patient group input closed3 | June 07, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | June 15, 2017 |
| Patient group comments on input summary closed | June 22, 2017 |
| Clarification: - Patient input submission received | |
| Submission received | May 16, 2017 |
| Submission accepted for review | May 31, 2017 |
| Review initiated | June 01, 2017 |
| Draft CDR review report(s) sent to applicant | August 21, 2017 |
| Comments from applicant on draft CDR review report(s) received | August 30, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | September 07, 2017 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | October 05, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | October 18, 2017 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | October 31, 2017 |
| Embargo4 period ended and validation of redacted CDR review report(s) received | November 14, 2017 |
| CDEC Final Recommendation issued to applicant and drug plans | November 21, 2017 |
| CDEC Final Recommendation posted5 | November 23, 2017 |
| Final CDR review report(s) and patient input posted5 | December 15, 2017 |