Generic Name: onabotulinumtoxinA
Brand Name: Botox
Manufacturer: Allergan 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: Active
Biosimilar: No
Companion Diagnostics: No
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 CDR review report(s) sent to applicant | February 20, 2019 |
| Comments from applicant on draft CDR review report(s) received | March 01, 2019 |
| Redaction requests from applicant on draft CDR review report(s) received | March 08, 2019 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | March 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | April 10, 2019 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 23, 2019 To April 25, 2019 |
Tags
headache disorders, nervous system