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inclisiran

Last Updated: April 12, 2021
Result type: Reports
Project Number: SR0681-000
Product Line: Reimbursement Review

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.

Key Milestones2

Call for patient/clinician input openFebruary 17, 2021
Call for patient/clinician input closedApril 09, 2021
Clarification:

- Patient input submission received from the Canadian Heart Patient Alliance (CHPA) and HeartLife Foundation

Submission receivedMarch 17, 2021
Submission acceptedMarch 31, 2021
Review initiatedApril 01, 2021
Draft CADTH review report(s) provided to sponsor for commentJune 16, 2021
Deadline for sponsors commentsJune 25, 2021
CADTH responses on draft review report(s) provided to sponsorAugust 06, 2021
Expert committee meeting (initial)August 18, 2021
Draft recommendation issued to sponsorAugust 30, 2021
To
September 01, 2021
Draft recommendation posted for stakeholder feedback-
End of feedback period-