Last Updated : May 24, 2023
Details
Generic Name:
inclisiran
Project Status:
Pending
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:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Novartis Pharmaceuticals Canada Inc. respectfully requests the reimbursement of Leqvio as per Health Canada approved indication: as an adjunct to lifestyle changes, including diet, and maximally tolerated dose of statin therapy, with or without other LDL-C-lowering therapies, in adult patients with HeFH or nFH with ASCVD, who require additional lowering of low-density lipoprotein cholesterol (LDL‐C).
Submission Type:
Resubmission
Fee Schedule:
Pending
Indications:
As per the Health Canada approved indication, for primary hypercholesterolemia (Heterozygous familial hypercholesterolemia (HeFH) and non-familial hypercholesterolemia (nFH)) with atherosclerotic cardiovascular disease (ASCVD).
Anticipated Date:
- 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.
Last Updated : May 24, 2023