erenumab


( Last Updated : September 21, 2020)
Generic 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

Details

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:
  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 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

Recommendation and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Group Input Submissions