Last Updated : December 17, 2021
Details
FilesGeneric 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
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:
- 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/clinician input open | 29-Apr-21 |
| Call for patient/clinician input closed | 18-Jun-21 |
| Clarification: - No patient input submission received | |
| Submission received | 28-May-21 |
| Submission accepted | 11-Jun-21 |
| Review initiated | 14-Jun-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 27-Aug-21 |
| Deadline for sponsors comments | 08-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 | 10-Nov-21 |
| Draft recommendation posted for stakeholder feedback | 18-Nov-21 |
| End of feedback period | 02-Dec-21 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 23-Feb-22 |
| Final recommendation issued to sponsor and drug plans | 08-Mar-22 |
| Final recommendation posted | 24-Mar-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 22-Mar-22 |
| CADTH review report(s) posted | 14-Apr-22 |
Files
Last Updated : December 17, 2021