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onabotulinumtoxinA

Last Updated: December 17, 2018
Result type: Reports
Project Number: SR0584-000
Product Line: Common Drug Review

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

  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 accepted for reviewNovember 16, 2018
Review initiatedNovember 19, 2018
Draft CADTH review report(s) sent to applicantFebruary 20, 2019
Comments from applicant on draft CADTH review report(s) receivedMarch 01, 2019
Redaction requests from applicant on draft CADTH review report(s) receivedMarch 08, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantMarch 29, 2019
Canadian Drug Expert Committee (CDEC) meetingApril 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant 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