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erenumab

Last Updated: September 18, 2020
Result type: Reports
Project Number: SR0578-000
Product Line: Common Drug Review

Generic Name: erenumab

Brand Name: Aimovig

Manufacturer: Novartis Pharmaceuticals Canada Inc.

Indications: Migraine

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: New

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: July 22, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 postedApril 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 closedMay 27, 2019
Clarification:

- Patient input submission received from Migraine Canada Migraine Quebec

Patient input summary sent for review to patient input groupsJune 03, 2019
Patient group comments on input summary closedJune 10, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 02, 2019
Submission acceptedMay 16, 2019
Review initiatedMay 17, 2019
Draft CADTH review report(s) sent to sponsorAugust 01, 2019
Comments from sponsor on draft CADTH review report(s) receivedAugust 13, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorOctober 03, 2019
Canadian Drug Expert Committee (CDEC) meetingOctober 16, 2019
CDEC recommendation sent to sponsor and drug plansOctober 30, 2019
Embargo period endedDecember 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 agendaMarch 18, 2020
CDEC recommendation sent to sponsor and drug plansMarch 25, 2020
Embargo period endedMay 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 plansJuly 22, 2020
CDEC Final Recommendation postedJuly 24, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedAugust 06, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansAugust 18, 2020
Validation of redacted CADTH review report(s) receivedAugust 25, 2020
Final CADTH review report(s) postedSeptember 18, 2020