Generic Name: onabotulinumtoxinA
Brand Name: Botox
Manufacturer: Allergan Canada Inc.
Indications: Migraine, chronic
Manufacturer Requested Reimbursement Criteria1: For the prophylaxis of headaches in adults with chronic migraine (15 days per month with headache lasting 4 hours a day or longer).
Submission Type: Resubmission
Project Status: Complete
Biosimilar: No
Companion Diagnostics: No
Date Recommendation Issued: October 17, 2019
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule B
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient input posted | September 26, 2018 |
| Patient group input closed | November 15, 2018 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | November 28, 2018 |
| Patient group comments on input summary closed | December 05, 2018 |
| Clarification: - No patient input summary feedback received | |
| Submission received | November 02, 2018 |
| Submission accepted for review | November 16, 2018 |
| Review initiated | November 19, 2018 |
| Draft CADTH review report(s) sent to sponsor | February 20, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | March 01, 2019 |
| Redaction requests from sponsor on draft CADTH review report(s) received | March 08, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | March 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | April 10, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans | April 25, 2019 |
| Embargo period ended and validation of redacted CADTH review report(s) received | June 07, 2019 |
| Clarification: - Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested | |
| Sponsor's request for reconsideration placed on CDEC agenda | September 18, 2019 |
| CDEC recommendation sent to sponsor and drug plans | September 25, 2019 |
| Embargo period ended | October 09, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | October 17, 2019 |
| CDEC Final Recommendation posted | October 22, 2019 |
| Final CADTH review report(s) posted | November 19, 2019 |