For prevention of migraine in adults who have at least 8 migraine days per month and who have previously failed, are intolerant, or have a contraindication to at least two migraine preventive therapies
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Migraine
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
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
April 04, 2019
Clarification:
CADTH initially posted the call for patient from July 12, 2018 to August 31, 2018. The pending submission was subsequently delayed and CADTH re-posted the call for patient input when the revised filing date was received.
Patient group input closed
May 27, 2019
Clarification:
- Patient input submission received from Migraine Canada Migraine Quebec
Patient input summary sent for review to patient input groups
June 03, 2019
Patient group comments on input summary closed
June 10, 2019
Clarification:
- Patient input summary feedback received
Submission received
May 02, 2019
Submission accepted
May 16, 2019
Review initiated
May 17, 2019
Draft CADTH review report(s) sent to sponsor
August 01, 2019
Comments from sponsor on draft CADTH review report(s) received
August 13, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor
October 03, 2019
Canadian Drug Expert Committee (CDEC) meeting
October 16, 2019
CDEC recommendation sent to sponsor and drug plans
October 30, 2019
Embargo period ended
December 11, 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
March 18, 2020
CDEC recommendation sent to sponsor and drug plans
March 25, 2020
Embargo period ended
May 13, 2020
Clarification:
- Request for extension to embargo period received from the sponsor
- Embargo extension request granted
- Reconsideration requested
- Sponsors request for reconsideration placed on the July 15, 2020 CDEC agenda
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans
July 22, 2020
CDEC Final Recommendation posted
July 24, 2020
Redaction requests from sponsor on draft CADTH review report(s) received
August 06, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans
August 18, 2020
Validation of redacted CADTH review report(s) received