Last Updated : October 23, 2024
Details
FilesGeneric Name:
inclisiran
Project Status:
Active
Therapeutic Area:
Primary hypercholesterolemia
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Leqvio
Project Line:
Reimbursement Review
Project Number:
SR0791-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) level in adults who are on maximally tolerated dose of a statin, with or without other LDL-C -lowering therapies, and who have heterozygous familial hypercholesterolemia (HeFH).
Submission Type:
Resubmission
Fee Schedule:
Schedule A
Indications:
As an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) level in adults with the following conditions who are on maximally tolerated dose of a statin, with or without other LDL-C -lowering therapies: Heterozygous familial hypercholesterolemia (HeFH), or Non-familial hypercholesterolemia with atherosclerotic cardiovascular disease
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.
| Call for patient/clinician input open | 24-May-23 |
|---|---|
| Call for patient/clinician input closed | 14-Jul-23 |
| Clarification: - Patient input submission received from Canadian Heart Patient Alliance and HeartLife Foundation | |
| Submission received | 19-Sep-23 |
| Submission accepted | 04-Oct-23 |
| Review initiated | 05-Oct-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 20-Dec-23 |
| Deadline for sponsors comments | 08-Jan-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 15-Feb-24 |
| Expert committee meeting (initial) | 28-Feb-24 |
| Draft recommendation issued to sponsor | 13-Mar-24 |
| Draft recommendation posted for stakeholder feedback | 21-Mar-24 |
| End of feedback period | 08-Apr-24 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 26-Jun-24 |
| Draft recommendation issued to sponsor | 11-Jul-24 |
| Draft recommendation posted for stakeholder feedback | 18-Jul-24 |
| End of feedback period | 01-Aug-24 |
| Final recommendation issued to sponsor and drug plans | 15-Aug-24 |
| Final recommendation posted | 03-Sep-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 29-Aug-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : October 23, 2024