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 |