inclisiran

Generic Name: inclisiran

Brand Name: TBC

Manufacturer: Novartis Pharmaceuticals Canada Inc.

Therapeutic Area: Primary hypercholesterolemia

Indications: Inclisiran is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial), as an adjunct to diet: • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low density lipoprotein cholesterol (LDL-C) goals with the tolerated dose of a statin or, • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Manufacturer Requested Reimbursement Criteria¹: As an adjunct to diet and maximally tolerated statin (MTS) therapy, with or without other lipidlowering therapies (LLT), in adult patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDLC.

Submission Type: Initial

NOC Status at Filing: Pre NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule A

1. 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.