inclisiran

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Generic Name:

inclisiran

Project Status:

Complete

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

Performance Metric:

Achieved

Biosimilar:

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.

Recommendation Type:

Do not reimburse

Final Recommendation:

February 7, 2022

The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Procedural review: CADTH accepted a procedural review request, submitted by Novartis Pharmaceuticals Canada Inc., for the SR0681-000 Leqvio CDEC Final Recommendation.

Status: Concluded.

Description: This matter was concluded following adjudication by a Procedural Review Panel (the “Panel”). In its decision, the Panel found that CADTH/CDEC had acted in accordance with the Procedures for CADTH Reimbursement Reviews for the review of Leqvio.

The Panel’s decision was provided in a memorandum report to CADTH. CADTH has prepared a response to address the findings of the procedural review

Outcome: The CDEC Final Recommendation of Do Not Reimburse is upheld for Leqvio.

Key Milestones²
Call for patient/clinician input open	17-Feb-21
Call for patient/clinician input closed	09-Apr-21
Clarification: - Patient input submission received from the Canadian Heart Patient Alliance (CHPA) and HeartLife Foundation
Submission received	17-Mar-21
Submission accepted	31-Mar-21
Review initiated	01-Apr-21
Draft CADTH review report(s) provided to sponsor for comment	16-Jun-21
Deadline for sponsors comments	25-Jun-21
CADTH responses on draft review report(s) provided to sponsor	06-Aug-21
Expert committee meeting (initial)	18-Aug-21
Draft recommendation issued to sponsor	30-Aug-21
Draft recommendation posted for stakeholder feedback	09-Sep-21
End of feedback period	23-Sep-21
Clarification: - Reconsideration: major revisions requested by sponsor
Expert committee meeting	26-Jan-22
Final recommendation issued to sponsor and drug plans	07-Feb-22
Final recommendation posted	24-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	22-Feb-22
CADTH review report(s) posted	19-Apr-22
Procedural review accepted	14-Apr-22
Procedural review concluded	20-Jun-22
Clarification: -Final Recommendation upheld