Last Updated : September 21, 2020
Details
FilesGeneric Name:
erenumab
Project Status:
Complete
Therapeutic Area:
Migraine
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Aimovig
Project Line:
Reimbursement Review
Project Number:
SR0578-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
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 | August 25, 2020 |
| Final CADTH review report(s) posted | September 18, 2020 |
Files
Last Updated : September 21, 2020