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BC PharmaCare

YourVoice Drug Information

The drug below is being considered for 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. 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 indication. 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 for that indication.

Information about the drug Generic name (scientific degludec – name) Brand name Xultophy® Manufacturer Novo Nordisk Indication Type 2 Diabetes Mellitus Has the drug been reviewed is currently under review by the CDR. by the Common Drug For more information about the CDR’s review of baricitinib (Olumiant), you Review (CDR)? can Search the CDR Reports. The CDR is a national organization that reviews drugs on behalf of Canadian public sector plans when manufacturers want the jurisdictions to provide coverage for the drugs. Public input start date Thursday, June 6, 2019 Public input closing date Thursday, July 4, 2019 AT MIDNIGHT How is the drug taken? Xultophy is available as a solution for injection under the skin via a pre-filled pen. It is usually taken in combination with other diabetes treatments. How often is the drug taken? Xultophy is administered once per day.

Ministry of Health Pharmaceutical Services Division Page 1 of 6 BC PharmaCare Drug Information - liraglutide (XULTOPHY®)

Information about the drug General drug and/or drug study Xultophy contains two drugs that help regulate blood sugar in the body. information The first drug is called insulin degludec. Insulin degludec is a long-acting basal insulin which lowers blood sugar levels in the body. The second drug is liraglutide. Liraglutide is a -like -1 (GLP-1) receptor agonist which helps the body to make more insulin during meals and lowers the amount of sugar made by the body.

Studies of Xultophy looked at: • Diabetes-related outcomes (e.g., coronary heart disease, neuropathy) • Deaths (caused by any cause or related to cardiovascular causes) • Blood sugar control (e.g., hemoglobin A1c, fasting or post-meal blood sugar measurements) • Health-related quality of life • Body mass index or body weight • Blood pressure • Bad reactions • Serious bad reactions • Patients leaving the trial due to bad reactions • Bad reactions of special interest (e.g., low blood sugar, kidney failure)

Cost of the drug under review compared to other drugs used to treat the same indication generic name PharmaCare Status Usual Dose Annual Cost of Therapy (Brand Name) of (if and how the drug is ($) Drug Comparator already covered) Insulin and glucagon-like peptide-1 (GLP-1) receptor agonist combinations 16 to 50 U insulin degludec Insulin degludec - liraglutide and 0.58 to 1.8 mg liraglutide 1,184 (16 U) to 3,699 (50 U) Under Review (XULTOPHY®) once a day. Max daily dose: 50 U

15 to 60 U Insulin glargine - and 5 to 20 mcg lixisenatide 694 (15 U) to 2,770 (60 U) Under Review once a day. Starting dose not (SOLIQUA®) > 10 mcg lixisenatide.

Max daily dose: 60 U

Glucagon-like peptide-1 (GLP-1) receptor agonists Under Review 0.5 to 1 mg once weekly 2,544 (OZEMPIC®)

Dulaglutide Under Review 0.75 to 1.5 mg once weekly 2,596 (TRULICITY®)

Ministry of Health Pharmaceutical Services Division Page 2 of 6 BC PharmaCare Drug Information insulin degludec - liraglutide (XULTOPHY®)

Cost of the drug under review compared to other drugs used to treat the same indication generic name PharmaCare Status Usual Dose Annual Cost of Therapy (Brand Name) of (if and how the drug is ($) Drug Comparator already covered) Non-Benefit 5 to 10 mcg twice daily 1,748 (BYETTA®)

Exenatide Pending Review 2 mg once weekly 2,580 (BYDUREON®)

Liraglutide Under Review 1.2 to 1.8 mg daily 2,170 to 3,256 (VICTOZA®)

Starting dose of 10 mcg once Lixisenatide Non-Benefit daily for 14 days, after which 1,486 (ADLYXINE™) the dose should be increased to 20 mcg once daily

Metformin 500 mg three to four times Regular Benefit daily, or 850 mg two to three 25 to 36 (generics) times daily.

Sulfonylureas Gliclazide Limited Coverage 80 to 320 mg daily 34 to 136 (generics)

Gliclazide long-acting Limited Coverage 30 to 120 mg daily 22 to 44 (generics)

Glimepiride Non-Benefit 1 to 4 mg daily 179 (generics)

Glyburide Regular Benefit 2.5 to 20 mg daily 12 to 84 (generics)

Thiazolidinediones (TZDs) Pioglitazone (generics) Limited Coverage 15 to 45 mg daily 139 to 295

Rosiglitazone Non-Benefit 4 to 8 mg daily 591 to 845 (generics)

Meglitinides Repaglinide (generics) Non-Benefit 0.5 to 2 mg daily 76 to 89

Alpha-glucosidase inhibitors 50 to 100 mg three times Acarbose (GLUCOBAY®) Non-Benefit 295 to 409 daily

Ministry of Health Pharmaceutical Services Division Page 3 of 6 BC PharmaCare Drug Information insulin degludec - liraglutide (XULTOPHY®)

Cost of the drug under review compared to other drugs used to treat the same indication generic name PharmaCare Status Usual Dose Annual Cost of Therapy (Brand Name) of (if and how the drug is ($) Drug Comparator already covered) Sodium- transport protein (SGLT2) inhibitors Canagliflozin Under Review 100 or 300 mg daily 1,026 (INVOKANA®)

Dapagliflozin Under Review 5 or 10 mg daily 976 (FORXIGA®)

Empagliflozin Under Review 10 or 25 mg daily 976 (JARDIANCE®)

Ertugliflozin (STEGLATRO™) Under Review 5 to 15 mg daily 966a

SGLT2 inhibitor plus metformin fixed dose combinations Canagliflozin-metformin Under Review One tablet twice a day 1,153 (INVOKAMET®) Dapagliflozin-metformin Under Review One tablet twice a day 894 (XIGDUO®) -metformin Under Review One tablet twice a day 1,006 (SYNJARDY™) Ertugliflozin - metformin Under Review One tablet twice a day 966a (SEGLUROMET™)

Dipeptidyl peptidase-4 (DPP-4) inhibitors Alogliptin Non-Benefit 25 mg daily 803 (NESINA®) Limited Coverage 5 mg daily 950 (TRAJENTA®) Saxagliptin Limited Coverage 5 mg daily 904 to 1,083 (ONGLYZA®) Sitagliptin Non-Benefit 100 mg daily 1,129 (JANUVIA®)

DPP-4 inhibitor plus metformin fixed dose combinations Alogliptin- Two tablets daily metformin Non-Benefit 872 (KAZANO®)

Linagliptin- Limited Coverage Two tablets daily metformin 997

(JENTADUETO®)

Ministry of Health Pharmaceutical Services Division Page 4 of 6 BC PharmaCare Drug Information insulin degludec - liraglutide (XULTOPHY®)

Cost of the drug under review compared to other drugs used to treat the same indication generic name PharmaCare Status Usual Dose Annual Cost of Therapy (Brand Name) of (if and how the drug is ($) Drug Comparator already covered) Saxagliptin- Limited Coverage Two tablets daily metformin 927

(KOMBOGLYZE®)

JANUMET: Twice daily. Maximal daily dose: 100 mg sitagliptin & 2000 mg Sitagliptin- metformin Non-Benefit metformin 613 to 1,225 JANUMET XR: Once a day. (JANUMET®, JANUMET® XR) Maximal daily: 100 mg sitagliptin & 2000 mg metformin

All prices are from the Common Drug Review Pharmacoeconomic Review Report for insulin delgudec – liraglutide (XULTOPHY) unless otherwise stated. a Price obtained from drug distributor.

The Drug Review Process in British Columbia

A manufacturer submits a request to the Ministry of Health (the Ministry) to have their drug covered by PharmaCare.

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: • 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.

Ministry of Health Pharmaceutical Services Division Page 5 of 6 BC PharmaCare Drug Information insulin degludec - liraglutide (XULTOPHY®)

Ministry of Health Pharmaceutical Services Division Page 6 of 6