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onabotulinumtoxinA

Last Updated: June 17, 2020
Result type: Reports
Project Number: SR0584-000
Product Line: Common Drug Review

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

  1. 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 postedSeptember 26, 2018
Patient group input closedNovember 15, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsNovember 28, 2018
Patient group comments on input summary closedDecember 05, 2018
Clarification:

- No patient input summary feedback received

Submission receivedNovember 02, 2018
Submission acceptedNovember 16, 2018
Review initiatedNovember 19, 2018
Draft CADTH review report(s) sent to sponsorFebruary 20, 2019
Comments from sponsor on draft CADTH review report(s) receivedMarch 01, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedMarch 08, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorMarch 29, 2019
Canadian Drug Expert Committee (CDEC) meetingApril 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansApril 25, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedJune 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 agendaSeptember 18, 2019
CDEC recommendation sent to sponsor and drug plansSeptember 25, 2019
Embargo period endedOctober 09, 2019
CDEC Final Recommendation issued to sponsor and drug plansOctober 17, 2019
CDEC Final Recommendation postedOctober 22, 2019
Final CADTH review report(s) postedNovember 19, 2019