fremanezumab

Details

Files
Generic Name:
fremanezumab
Project Status:
Complete
Therapeutic Area:
migraine
Manufacturer:
Teva Canada Innovation
Call for patient/clinician input open:
Brand Name:
Ajovy
Project Line:
Reimbursement Review
Project Number:
SR0641-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the prevention of migraine in adults who have at least 4 migraine days per month.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Indicated for 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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input openMarch 30, 2020
Call for patient input closedMay 20, 2020
Clarification:

- Patient input submission received from Migraine Canada and Migraine Quebec

Submission receivedJune 03, 2020
Submission acceptedSeptember 22, 2020
Clarification:

- Submission was not accepted for review on 17 June 2020

Review initiatedSeptember 23, 2020
Draft CADTH review report(s) provided to sponsor for commentDecember 18, 2020
Deadline for sponsors commentsJanuary 06, 2021
CADTH responses on draft review report(s) provided to sponsorFebruary 04, 2021
CADTH review report(s) and responses to comments provided to sponsorFebruary 04, 2021
Expert committee meeting (initial)February 17, 2021
Draft recommendation issued to sponsorMarch 03, 2021
End of embargo periodMarch 17, 2021
Final recommendation issued to sponsor and drug plansMarch 24, 2021
Final recommendation postedMarch 26, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)April 08, 2021
CADTH review report(s) postedMay 28, 2021