葡萄糖钠转运体-2 抑制剂和胰高血糖素样肽-1 受体激动剂的处方管理

Daniel Trinh, Matthew McDonald
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摘要

加拿大卫生部已批准了 4 种钠-葡萄糖共转运体-2 (SGLT2) 抑制剂(ertugliflozin、dapagliflozin、canagliflozin 和 empagliflozin)和 5 种胰高血糖素样肽-1 (GLP-1) 受体激动剂(semaglutide、liraglutide、dulaglutide、lixisenatide 和 exenatide),以及 5 种固定剂量复方产品(SGLT2 抑制剂:dapagliflozin-二甲双胍、canagliflozin-二甲双胍和 empagliflozin-二甲双胍;GLP-1 受体激动剂:liraglutide-二甲双胍和 exenatide):二甲双胍;GLP-1 受体激动剂:利拉鲁肽-胰岛素 degludec 和利西那肽-胰岛素 glargine)。在加拿大,所有 SGLT2 抑制剂及其固定剂量组合的数据保护均已结束。目前已有 11 种达帕格列净(dapagliflozin)仿制药上市,加拿大卫生部正在审查几种卡格列净(canagliflozin)和恩格列净(empagliflozin)仿制药。GLP-1 受体激动剂的专利保护尚未到期。每种 SGLT2 抑制剂和 GLP-1 受体激动剂的公共药品计划报销标准都不尽相同,从限制获益到非限制获益不等。本环境扫描报告强调,随着 SGLT2 抑制剂和 GLP-1 受体激动剂的成熟,除了最初获得加拿大卫生部批准的适应症(2 型糖尿病)外,还增加了其他适应症(心力衰竭、慢性肾病、体重管理)。SGLT2 抑制剂开始失去其独占地位,并面临非专利药的竞争。
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Formulary Management of Sodium-Glucose Cotransporter-2 Inhibitors and Glucagon-Like Peptide-1 Receptor Agonists
Health Canada has approved 4 sodium-glucose cotransporter-2 (SGLT2) inhibitors (ertugliflozin, dapagliflozin, canagliflozin, and empagliflozin) and 5 glucagon-like peptide-1 (GLP-1) receptor agonists (semaglutide, liraglutide, dulaglutide, lixisenatide, and exenatide), with 5 fixed-dose combination products (SGLT2 inhibitors: dapagliflozin-metformin, canagliflozin-metformin, and empagliflozin-metformin; GLP-1 receptor agonists: liraglutide–insulin degludec and lixisenatide–insulin glargine). Data protection has ended for all SGLT2 inhibitors in Canada as well as their fixed-dose combinations. Eleven dapagliflozin generics are currently available, and there are several canagliflozin and empagliflozin generics under review at Health Canada. Patent protection has not expired for GLP-1 receptor agonists. There is heterogeneity in public drug program reimbursement criteria for each SGLT2 inhibitor and GLP-1 receptor agonist ranging from restricted to unrestricted benefit. This Environmental Scan highlights that as SGLT2 inhibitors and GLP-1 receptor agonists have matured, additional indications (heart failure, chronic kidney disease, weight management) have been added to their initial Health Canada–approved indication (type 2 diabetes mellitus). SGLT2 inhibitors are beginning to lose their exclusivity status and are experiencing generic competition.
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