atogepant

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Generic Name:
atogepant
Project Status:
Active
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
Performance Metric:
Achieved
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 open30-Oct-23
Call for patient/clinician input closed22-Dec-23
Clarification:

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

Submission received21-Dec-23
Submission accepted12-Jan-24
Review initiated15-Jan-24
Draft CADTH review report(s) provided to sponsor for comment02-Apr-24
Deadline for sponsors comments11-Apr-24
CADTH review report(s) and responses to comments provided to sponsor09-May-24
Expert committee meeting (initial)22-May-24
Draft recommendation issued to sponsor04-Jun-24
Draft recommendation posted for stakeholder feedback13-Jun-24
End of feedback period27-Jun-24
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration not accepted

Final recommendation issued to sponsor and drug plans15-Jul-24
Final recommendation posted31-Jul-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)29-Jul-24
CADTH review report(s) posted-