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
- 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.
|Call for patient/clinician input open||February 17, 2021|
|Call for patient/clinician input closed||April 09, 2021|
- Patient input submission received from the Canadian Heart Patient Alliance (CHPA) and HeartLife Foundation
|Submission received||March 17, 2021|
|Submission accepted||March 31, 2021|
|Review initiated||April 01, 2021|
|Draft CADTH review report(s) provided to sponsor for comment||June 16, 2021|
|Deadline for sponsors comments||June 25, 2021|
|CADTH responses on draft review report(s) provided to sponsor||August 06, 2021|
|Expert committee meeting (initial)||August 18, 2021|
|Draft recommendation issued to sponsor||August 30, 2021|
September 01, 2021
|Draft recommendation posted for stakeholder feedback||-|
|End of feedback period||-|