Last Updated : June 26, 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
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
- 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.
| 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 |
Files
Last Updated : June 26, 2024