The drug below is being considered for possible coverage under the B.C. PharmaCare program. PharmaCare is a government-funded drug plan that helps British Columbians with the cost of eligible prescription drugs and specific medical supplies. For more information on PharmaCare, visit Ministry of Health - PharmaCare. PharmaCare reviews each drug for treating a specific illness or medical condition (known as an “indication”). If a decision is made to cover the drug, it will be only for that illness or condition. In some cases, PharmaCare may cover a drug only for people who have the illness or condition and have not responded to other drugs used to treat that illness or condition. For more information on PharmaCare’s drug coverage review process, see the last page of this information sheet.

Information about the drug Generic name (scientific name) inclisiran Brand name (TBC) Manufacturer Novartis Pharmaceuticals Canada Inc. Indication Primary hypercholesterolemia in adults Has the drug been reviewed by Yes the Common Drug For more information about the CDR’s review of inclisiran (TBC), you can Search the Review (CDR)? CDR Reports. (see the note below this table.) Public input start date Wednesday, July 21, 2021 Public input closing date Wednesday, August 18, 2021, AT MIDNIGHT How is the drug taken? Inclisiran is injected subcutaneously (under the skin). How often is the drug Inclisiran is injected once initially, then once again after three months, and then once injected? every six months thereafter.

Ministry of Health Pharmaceutical, Laboratory & Blood Services Division Page 1 of 5 BC PharmaCare Drug Information — inclisiran (TBC) continued…

Information about the drug General drug and/or drug Inclisiran is used to treat primary hypercholesterolemia in adults, along with a study information cholesterol-lowering diet. Primary hypercholesterolemia is a term that refers to high blood cholesterol levels, particularly low-density lipoprotein cholesterol (LDL-C), which is often called “bad” cholesterol. Primary hypercholererolemia can either be inherited or it can be caused by external factors such as smoking, diet, inactivity, type 2 diabetes, and/or an underactive thyroid.

Inclisiran uses one of the body’s own natural processes to lower LDL-C levels. It works by limiting the production of a protein called PCSK9 (proprotein convertase subtilisin/kexin type 9) that can increase LDL-C levels. By preventing its production, inclisiran can lower your levels of LDL-C.

Studies looked at the following: • Percent change in LDL-C levels from baseline to Day 510 • Average percentage change in LDL-C from baseline during the period after day 90 and up to day 540 • Incidences of death from cardiovascular disease • Resuscitated cardiac arrests • Non-fatal heart attacks • Non-fatal strokes • Bad reactions • Serious bad reactions • Patients leaving the trial due to bad reactions • Bad reactions of special interest (brain damage, injection site reactions, kidney damage, liver damage, reactions to the ) Other considerations None

Note: The Common Drug Review (CDR) is a national organization that reviews drugs on behalf of Canadian public sector plans when manufacturers want to have the jurisdictions provide coverage for the drugs. For detailed information on B.C. PharmaCare’s drug review process, including the role of the CDR in that process, see The Drug Review Process in B.C. - Overview.

Cost of the drug under review compared to other drugs used to treat the same indication generic name PharmaCare Status Dosage Form Usual Dose Annual Cost of (Brand Name) of (if and how the drug Therapy Drug Comparator is already covered) 1 syringe administered initially, Single-use, pre-filled Inclisiran (TBC) Under Review at month 3, and then Not available syringe every 6 months thereafter

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Cost of the drug under review compared to other drugs used to treat the same indication generic name PharmaCare Status Dosage Form Usual Dose Annual Cost of (Brand Name) of (if and how the drug Therapy Drug Comparator is already covered) Anti-PCSK9 Monoclonal Antibody Single-use, prefilled cartridge or single Once every 2 weeks Limited Coverage $7,316 (Repatha) use, pre-filled syringe or once monthly or autoinjector

Alirocumab Single-use pre-filled Once every 2 weeks Non-Benefit $7,263a (Praluent) pen or syringe or once monthly HMG-CoA Reductase Inhibitors () Regular Benefit, calcium subject to RDP and Tablet Once daily $69 - $92 (generic) LCA

Regular Benefit, subject to RDP and Capsule Once daily $271 - $762 sodium LCA

Fluvastatin Regular Benefit, sodium subject to RDP and Tablet Once daily $640 (Lescol XL) LCA

Regular Benefit, subject to RDP and Tablet Once daily $194 - $354 LCA

Regular Benefit, subject to RDP and Tablet Once daily $136 - $327 sodium LCA

Rosuvastatin Regular Benefit, calcium subject to RDP and Tablet Once daily $53 - $78 (generics) LCA

Regular Benefit, subject to RDP and Tablet Once daily $80 - $99 (generics) LCA Cholesterol Absorption Inhibitor Limited Coverage and coverage under Tablet Once daily $71 (Ezetrol) Plan W Lipid-Regulating Agent

a Manufacturer’s submitted price

Ministry of Health Pharmaceutical, Laboratory & Blood Services Division Page 3 of 5 BC PharmaCare Drug Information — inclisiran (TBC) continued…

Cost of the drug under review compared to other drugs used to treat the same indication generic name PharmaCare Status Dosage Form Usual Dose Annual Cost of (Brand Name) of (if and how the drug Therapy Drug Comparator is already covered) Icosapent $3,863Error! ethyl Under Review Capsule Twice daily Bookmark not (Vascepa) defined. (Bezalip, Non-Benefit Tablet Once daily $688b generic)

Fenofibrate Non-Benefit Capsule Three times daily $732 - $962b (Lipidil and generics)

Fenofibrate Regular Benefit, Tablet Once daily $182 - $465 (Lipidil EZ) subject to LCA

Gemfibrozil Regular Benefit Capsule Twice daily $514 (generic)

Micro-coated fenofibrate Regular Benefit Tablet Once daily $107 (generics)

b Price as per Ontario Drug Benefit Formulary plus 8%. RDP – Reference Drug Program LCA – Low cost alternative

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The Drug Review Process in B.C.

A manufacturer submits a request to the Ministry of Health (Ministry).

An independent group called the Drug Benefit Council (DBC) gives advice to the Ministry. The DBC looks at: • whether the drug is safe and effective • advice from a national group called the Common Drug Review (CDR) • what the drug costs and whether it is a good value for the people of B.C. • ethical considerations involved with covering or not covering the drug • input from physicians, patients, caregivers, patient groups and drug submission sponsors

The Ministry makes PharmaCare coverage decisions by taking into account: • the existing PharmaCare policies, programs and resources • the evidence-informed advice of the DBC • the drugs already covered by PharmaCare that are used to treat similar medical conditions • the overall cost of covering the drug

For more information about the B.C. Drug Review Process, visit: The Drug Review Process in B.C. - Overview.

This document is intended for information only. It does not take the place of advice from a physician or other qualified health care provider.

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