atogepant

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Generic Name:
atogepant
Project Status:
Complete
Therapeutic Area:
Migraine, prevention
Manufacturer:
AbbVie Corporation
Call for patient/clinician input open:
Brand Name:
Qulipta
Project Line:
Reimbursement Review
Project Number:
SR0817-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the prevention of chronic migraine in adults with 15 headache days per month (among which 8 days are considered to be migraine days) and who have previously failed, are intolerant to, or have a contraindication to at least two migraine preventive therapies.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
The prevention of migraine in adults who have at least 4 migraine days per month.
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openOctober 30, 2023
Call for patient/clinician input closedDecember 22, 2023
Clarification:

- Patient input submission received from the Canadian Migraine Society and Migraine Canada

Submission receivedDecember 21, 2023
Submission acceptedJanuary 12, 2024
Review initiatedJanuary 15, 2024
Draft CADTH review report(s) provided to sponsor for commentApril 02, 2024
Deadline for sponsors commentsApril 11, 2024
CADTH review report(s) and responses to comments provided to sponsorMay 09, 2024
Expert committee meeting (initial)May 22, 2024
Draft recommendation issued to sponsorJune 04, 2024
Draft recommendation posted for stakeholder feedbackJune 13, 2024
End of feedback periodJune 27, 2024
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration not accepted

Final recommendation issued to sponsor and drug plansJuly 15, 2024
Final recommendation postedJuly 31, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)July 29, 2024
CADTH review report(s) postedDecember 13, 2024