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onabotulinumtoxinA

Last Updated: December 6, 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 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 07, 2019
Comments from applicant on draft CDR review report(s) received February 19, 2019
Redaction requests from applicant on draft CDR review report(s) received February 26, 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