CDA | Evidence Driven
CDA | Evidence Driven

galcanezumab

Details

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Generic Name:
galcanezumab
Project Status:
Complete
Therapeutic Area:
Prevention of migraine
Manufacturer:
Eli Lilly Canada Inc. (Lilly)
Brand Name:
Emgality
Project Line:
Reimbursement Review
Project Number:
SR0693-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Eli Lilly Canada Inc. (Lilly) is requesting reimbursement for EMGALITY® (galcanezumab) for the prevention of migraine in adults who have at least four migraine days per month and have experienced an inadequate response, intolerance, or contraindication to at least two oral prophylactic migraine medications.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Emgality is indicated for the prevention of migraine in adults who have at least four 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 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 open05-May-21
Call for patient/clinician input closed28-Jun-21
Clarification:

- Patient input submission received from Migraine Canada Migraine Quebec

Submission received03-Jun-21
Submission accepted
Review initiated18-Jun-21
Draft CADTH review report(s) provided to sponsor for comment02-Sep-21
Deadline for sponsors comments14-Sep-21
CADTH responses on draft review report(s) provided to sponsor15-Oct-21
Expert committee meeting (initial)27-Oct-21
Draft recommendation issued to sponsor09-Nov-21
Draft recommendation posted for stakeholder feedback18-Nov-21
End of feedback period02-Dec-21
Final recommendation issued to sponsor and drug plans15-Dec-21
Final recommendation posted10-Jan-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)06-Jan-22
CADTH review report(s) posted01-Mar-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submissions View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : December 17, 2021