inclisiran

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Generic Name:
inclisiran
Project Status:
Active
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:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) level in adults who are on maximally tolerated dose of a statin, with or without other LDL-C -lowering therapies, and who have heterozygous familial hypercholesterolemia (HeFH).
Submission Type:
Resubmission
Fee Schedule:
Schedule A
Indications:
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
  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 open24-May-23
Call for patient/clinician input closed14-Jul-23
Clarification:

- Patient input submission received from Canadian Heart Patient Alliance and HeartLife Foundation

Submission received19-Sep-23
Submission accepted04-Oct-23
Review initiated05-Oct-23
Draft CADTH review report(s) provided to sponsor for comment20-Dec-23
Deadline for sponsors comments08-Jan-24
CADTH review report(s) and responses to comments provided to sponsor15-Feb-24
Expert committee meeting (initial)28-Feb-24
Draft recommendation issued to sponsor13-Mar-24
Draft recommendation posted for stakeholder feedback21-Mar-24
End of feedback period08-Apr-24
Clarification:

- Reconsideration: major revisions requested by sponsor