onabotulinumtoxinA


( Last Updated : June 18, 2020)
Generic Name:
onabotulinumtoxinA
Project Status:
Complete
Therapeutic Area:
Migraine, chronic
Manufacturer:
Allergan Canada Inc.
Call for patient/clinician input open:
Brand Name:
Botox
Project Line:
Reimbursement Review
Project Number:
SR0584-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details

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
Fee Schedule:
Schedule B
Indications:
Migraine, chronic
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 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

Files

Recommendations and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Group Input Submissions