atogepant

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Generic Name:
atogepant
Project Status:
Complete
Therapeutic Area:
Migraine, prevention
Manufacturer:
Allergan Inc. (an AbbVie company)
Call for patient/clinician input open:
Brand Name:
Qulipta
Project Line:
Reimbursement Review
Project Number:
SR0724-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the prevention of episodic migraine in adults with less than 15 migraine days per month who have experienced an inadequate response, intolerance or contraindication to at least two oral prophylactic migraine medications.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
The prevention of episodic migraine ( 15 migraine days per month) in adults.
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 open25-Jan-22
Call for patient/clinician input closed18-Mar-22
Clarification:

- Patient input submission received from Migraine Canada and Migraine Quebec (joint)

Submission received23-Feb-22
Submission accepted09-Mar-22
Review initiated10-Mar-22
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) provided to sponsor for comment08-Mar-23
Deadline for sponsors comments20-Mar-23
CADTH review report(s) and responses to comments provided to sponsor14-Apr-23
Expert committee meeting (initial)26-Apr-23
Draft recommendation issued to sponsor09-May-23
Draft recommendation posted for stakeholder feedback18-May-23
End of feedback period02-Jun-23
Final recommendation issued to sponsor and drug plans14-Jun-23
Final recommendation posted30-Jun-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)28-Jun-23
CADTH review report(s) posted30-Aug-23