Last Updated : April 22, 2024
Details
FilesGeneric Name:
inclisiran
Project Status:
Active
Therapeutic Area:
Primary hypercholesterolemia
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Brand Name:
Leqvio
Project Line:
Reimbursement Review
Project Number:
SR0791-001
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 non-familial hypercholesterolemia (nFH) with atherosclerotic cardiovascular disease (ASCVD).
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 | May 24, 2023 |
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Call for patient/clinician input closed | July 14, 2023 |
Clarification: - Patient input submission received from Canadian Heart Patient Alliance and HeartLife Foundation | |
Submission received | September 19, 2023 |
Submission accepted | October 04, 2023 |
Review initiated | October 05, 2023 |
Draft CADTH review report(s) provided to sponsor for comment | December 20, 2023 |
Deadline for sponsors comments | January 08, 2024 |
CADTH review report(s) and responses to comments provided to sponsor | February 15, 2024 |
Expert committee meeting (initial) | February 28, 2024 |
Draft recommendation issued to sponsor | March 13, 2024 |
Draft recommendation posted for stakeholder feedback | March 21, 2024 |
End of feedback period | April 08, 2024 |
Final recommendation issued to sponsor and drug plans | April 22, 2024 |
Final recommendation posted | - |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | July 25, 2024 |
CADTH review report(s) posted | - |
Files
Last Updated : April 22, 2024