inclisiran


( Last Updated : April 14, 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

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.

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