inclisiran


( Last Updated : September 9, 2021)
Generic Name:
inclisiran
Project Status:
Active
Therapeutic Area:
Primary hypercholesterolemia
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Brand Name:
Leqvio
Project Line:
Reimbursement Review
Project Number:
SR0681-000
NOC Status at Filing:
Pre NOC

Details


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
Fee Schedule:
Schedule A
Indications:
Leqvio is indicated 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 effect of Leqvio on cardiovascular morbidity and mortality has not been determined.
  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.

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Key Milestones2

Call for patient/clinician input open17-Feb-21
Call for patient/clinician input closed09-Apr-21
Clarification:

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

Submission received17-Mar-21
Submission accepted31-Mar-21
Review initiated01-Apr-21
Draft CADTH review report(s) provided to sponsor for comment16-Jun-21
Deadline for sponsors comments25-Jun-21
CADTH responses on draft review report(s) provided to sponsor06-Aug-21
Expert committee meeting (initial)18-Aug-21
Draft recommendation issued to sponsor30-Aug-21
Draft recommendation posted for stakeholder feedback09-Sep-21
End of feedback period23-Sep-21