Last Updated : December 17, 2021
Details
FilesGeneric 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:
- 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 open | 05-May-21 |
Call for patient/clinician input closed | 28-Jun-21 |
Clarification: - Patient input submission received from Migraine Canada Migraine Quebec | |
Submission received | 03-Jun-21 |
Submission accepted | |
Review initiated | 18-Jun-21 |
Draft CADTH review report(s) provided to sponsor for comment | 02-Sep-21 |
Deadline for sponsors comments | 14-Sep-21 |
CADTH responses on draft review report(s) provided to sponsor | 15-Oct-21 |
Expert committee meeting (initial) | 27-Oct-21 |
Draft recommendation issued to sponsor | 09-Nov-21 |
Draft recommendation posted for stakeholder feedback | 18-Nov-21 |
End of feedback period | 02-Dec-21 |
Final recommendation issued to sponsor and drug plans | 15-Dec-21 |
Final recommendation posted | 10-Jan-22 |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 06-Jan-22 |
CADTH review report(s) posted | 01-Mar-22 |
Files
Last Updated : December 17, 2021