Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

colchicine

Details

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Generic Name:
colchicine
Project Status:
Complete
Therapeutic Area:
Atherothrombotic events in coronary artery disease
Manufacturer:
Pendopharm, a division of Pharmascience Inc.
Brand Name:
Myinfla
Project Line:
Reimbursement Review
Project Number:
SR0691-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For reduction of atherothrombotic events in patients with existing coronary artery disease who had a myocardial infarction.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Reduction of atherothrombotic events in adult patients with existing coronary artery disease, in addition to standard therapies, including LDL-C lowering and antithrombotic drug treatment.
Recommendation Type:
Do not reimburse
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 open29-Apr-21
Call for patient/clinician input closed18-Jun-21
Clarification:

- No patient input submission received

Submission received28-May-21
Submission accepted11-Jun-21
Review initiated14-Jun-21
Draft Canada's Drug Agency review report(s) provided to sponsor for comment27-Aug-21
Deadline for sponsors comments08-Sep-21
Canada's Drug Agency responses on draft review report(s) provided to sponsor15-Oct-21
Expert committee meeting (initial)27-Oct-21
Draft recommendation issued to sponsor10-Nov-21
Draft recommendation posted for stakeholder feedback18-Nov-21
End of feedback period02-Dec-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting23-Feb-22
Final recommendation issued to sponsor and drug plans08-Mar-22
Final recommendation posted24-Mar-22
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)22-Mar-22
Canada's Drug Agency review report(s) posted14-Apr-22

Files

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