Department of Pharmacy Practice and Science, University of Nebraska Medical Center, Omaha.
J Manag Care Spec Pharm. 2021 Jul;27(7):840-845. doi: 10.18553/jmcp.2021.27.7.840.
Oral semaglutide is the first orally administered glucagon-like peptide-1 receptor agonist (GLP-1RA) approved by the FDA. Clinical trials found that oral semaglutide 14 mg had a greater reduction in hemoglobin A1c (A1c) compared with empagliflozin 25 mg and sitagliptin 100 mg and was noninferior to liraglutide 1.8 mg. However, US cost-effectiveness data for oral semaglutide are limited and do not consider the costs of adverse events. To assess the short-term cost-effectiveness of oral semaglutide compared with empagliflozin, sitagliptin, and liraglutide in patients with type 2 diabetes. A decision analysis over a 52-week time horizon was used to evaluate the incremental cost-effectiveness of oral semaglutide vs empagliflozin, sitagliptin, and liraglutide from a US health care payer's perspective. Data on efficacy, adverse events, and discontinuation were derived from 52-week data from phase 3, head-to-head clinical trials (PIONEER 2, 3, and 4). Costs included drug and administration cost and treatment of gastrointestinal adverse events. Incremental cost-effectiveness ratios (ICERs) were calculated as the difference in cost over the difference in A1c reduction between oral semaglutide and comparators. In the base-case analysis, 52-week treatment costs with oral semaglutide were $2,660 and $3,104 higher and $2,337 less than empagliflozin, sitagliptin, and liraglutide, respectively. Incremental (greater) A1c reductions were seen with oral semaglutide at 0.40%, 0.50%, and 0.30% vs empagliflozin, sitagliptin, and liraglutide, respectively. ICERs per 1% reduction in A1c for oral semaglutide were $6,650 and $6,207 vs empagliflozin and sitagliptin, respectively. Oral semaglutide was dominant vs liraglutide (ICER of -$7,790). Oral semaglutide was dominant relative to liraglutide, offering a cost-saving GLP-1RA oral alternative. While there is not a recognized willingness-to-pay threshold for a 1% reduction in A1c, oral semaglutide may be cost-effective relative to empagliflozin and sitagliptin if a decision maker's willingness-to-pay threshold exceeds $6,650 and $6,207, respectively. No outside funding supported this study. The authors have no conflicts of interest to declare.
口服司美格鲁肽是首个经美国食品药品监督管理局（FDA）批准的可口服的胰高血糖素样肽-1 受体激动剂（GLP-1RA）。临床试验发现，与恩格列净 25mg 和西格列汀 100mg 相比，口服司美格鲁肽 14mg 可使糖化血红蛋白（HbA1c）水平更大幅度下降，且与利拉鲁肽 1.8mg 非劣效。然而，美国关于口服司美格鲁肽的成本效益数据有限，并未考虑不良事件的成本。 本研究旨在评估口服司美格鲁肽与恩格列净、西格列汀和利拉鲁肽相比，在 2 型糖尿病患者中的短期成本效益。 采用 52 周时间范围的决策分析，从美国医疗保健支付者的角度评估口服司美格鲁肽相对于恩格列净、西格列汀和利拉鲁肽的增量成本效益。口服司美格鲁肽的疗效、不良事件和停药数据源自 3 项 52 周的头对头临床试验（PIONEER 2、3 和 4）。成本包括药物和管理费用以及胃肠道不良事件的治疗费用。增量成本效益比（ICER）计算为口服司美格鲁肽与对照组之间 HbA1c 降低差异的成本差异。 在基础分析中，口服司美格鲁肽的 52 周治疗成本分别比恩格列净、西格列汀和利拉鲁肽高 2660 美元、3104 美元和 2337 美元。与恩格列净、西格列汀和利拉鲁肽相比，口服司美格鲁肽的 HbA1c 分别有 0.40%、0.50%和 0.30%的增量（更大）降低。口服司美格鲁肽每降低 1%HbA1c 的 ICER 分别为 6650 美元和 6207 美元，与恩格列净和西格列汀相比。口服司美格鲁肽相对于利拉鲁肽具有优势（ICER 为-7790 美元）。 与利拉鲁肽相比，口服司美格鲁肽具有优势，为 GLP-1RA 提供了一种具有成本效益的口服替代药物。虽然没有公认的 A1c 降低 1%的支付意愿阈值，但如果决策者的支付意愿阈值分别超过 6650 美元和 6207 美元，口服司美格鲁肽可能比恩格列净和西格列汀具有成本效益。 本研究无外部资金支持。作者无利益冲突声明。
