Boston Healthcare Associates, Boston, MA.
Yale University School of Medicine, New Haven, CT.
J Manag Care Spec Pharm. 2022 Apr;28(4):461-472. doi: 10.18553/jmcp.2022.28.4.461.
Approximately 7.3 million people with type 1 or type 2 diabetes (T1D/T2D) are treated with insulin, placing them at higher risk of severe hypoglycemia (SH). SH requires assistance of another individual and often necessitates the prompt administration of intravenous glucose, injectable glucagon, or both. Untreated, SH can progress to unconsciousness, seizures, coma, or death. Before 2018, all glucagon rescue treatments required reconstitution. The complexity of reconstitution is often a barrier to successful administration during a severe hypoglycemic event. Studies suggest successful administration of glucagon emergency kits range from 6%-56% of the time. Second-generation glucagon treatments and glucagon analogs do not require reconstitution and have caregiver administration success rates ranging from 94%-100%. Dasiglucagon is a glucagon analog administered via autoinjector or prefilled syringe and has been shown to result in rapid hypoglycemia recovery. Moreover, the autoinjector can be administered successfully 94% of the time by trained caregivers. Previous evaluation of costs in budget impact models (BIMs) demonstrated the potential for second-generation glucagon treatments to reduce the cost of SH events (SHEs). The current model expands on those findings with a treatment pathway and accompanying assumptions reflecting important aspects of real-world SHE treatment. To evaluate the economic impact of dasiglucagon compared with available glucagon treatments for SHE management, considering direct cost of treatment and health care resource utilization. A 1-year BIM with a hypothetical US commercial health plan of 1 million lives was developed with a target population of individuals with diabetes at risk of SHE. The treatment pathway model included initial and secondary treatment attempts, treatment administration success and failure, plasma glucose (PG) recovery within 15 minutes, emergency medical services, emergency department (ED) visits, and hospitalizations. A 1-way sensitivity analysis was conducted to assess the sensitivity of the model to changes in parameter values. In a 1 million-covered lives population, it was estimated that 12,006 SHEs would occur annually. The higher rate of initial treatment success and PG recovery within 15 minutes associated with dasiglucagon treatment resulted in lower total health care costs. Total SHE treatment costs with dasiglucagon were estimated at $13.4 million, compared with $16.7 million for injectable native glucagon, $20.7 million for nasal glucagon, $35.3 million for reconstituted glucagon, and $43.8 million for untreated individuals. Compared with untreated people, the number needed to treat (NNT) with dasiglucagon was 6 individuals to avoid 1 hospitalization. NNT for this same comparison was 59 for injectable native glucagon and 27 for nasal glucagon. Treatment of SH with dasiglucagon decreased total direct medical costs by reducing health care resource utilization (emergency calls, emergency transports, ED visits, and hospitalizations) and accompanying costs associated with the treatment of SH. This research was funded by Zealand Pharma. Bromley, Hinahara, and Goss are employed by Boston Healthcare Associates, Inc., which received funding from Zealand Pharma for development of the health economic model and the manuscript. Kendall and Hammer are employed by Zealand Pharma. Weinzimer has received consulting fees from Zealand Pharma.
大约有 730 万 1 型或 2 型糖尿病(T1D/T2D)患者接受胰岛素治疗,这使他们面临严重低血糖(SH)的风险更高。SH 需要他人协助,通常需要迅速给予静脉葡萄糖、可注射的胰高血糖素或两者兼用。如果不治疗,SH 可能会发展为无意识、癫痫发作、昏迷或死亡。在 2018 年之前,所有的胰高血糖素急救治疗都需要重新配制。重新配制的复杂性通常是在严重低血糖事件中成功给药的障碍。研究表明,胰高血糖素急救包的成功给药时间范围为 6%-56%。第二代胰高血糖素治疗和胰高血糖素类似物不需要重新配制,其护理人员给药成功率为 94%-100%。Dasiglucagon 是一种通过自动注射器或预填充注射器给药的胰高血糖素类似物,已被证明可迅速恢复低血糖。此外,经过培训的护理人员可以 94%的时间成功使用自动注射器给药。之前在预算影响模型(BIM)中的成本评估表明,第二代胰高血糖素治疗有可能降低严重低血糖事件(SHE)的成本。目前的模型扩展了这些发现,提供了一条治疗途径和相应的假设,反映了现实世界中 SHE 治疗的重要方面。为了评估与可用的 SHE 管理治疗方法相比,Dasiglucagon 治疗 SHE 的经济影响,考虑了治疗的直接成本和医疗资源的利用情况。建立了一个具有 100 万生命的假设美国商业健康计划的 1 年 BIM,目标人群是有 SHE 风险的糖尿病患者。治疗途径模型包括初始和二次治疗尝试、治疗管理成功和失败、15 分钟内血糖(PG)恢复、紧急医疗服务、急诊(ED)就诊和住院。进行了单因素敏感性分析,以评估模型对参数值变化的敏感性。在 100 万覆盖人群中,估计每年会发生 12006 例 SHE。Dasiglucagon 治疗与更高的初始治疗成功率和 15 分钟内 PG 恢复相关,导致总医疗保健成本降低。Dasiglucagon 的总 SHE 治疗费用估计为 1340 万美元,而注射用天然胰高血糖素为 1670 万美元,鼻用胰高血糖素为 2070 万美元,重新配制的胰高血糖素为 3530 万美元,未治疗的个体为 4380 万美元。与未治疗的个体相比,Dasiglucagon 的治疗需要 6 个人才能避免 1 次住院。对于同样的比较,注射用天然胰高血糖素的 NNT 为 59,鼻用胰高血糖素的 NNT 为 27。Dasiglucagon 治疗 SH 通过减少卫生资源的利用(紧急呼叫、紧急转运、ED 就诊和住院)和伴随的 SH 治疗相关成本,降低了总直接医疗成本。这项研究由 Zealand Pharma 资助。Bromley、Hinahara 和 Goss 受雇于 Boston Healthcare Associates,Inc.,该公司因开发健康经济模型和手稿而从 Zealand Pharma 获得资金。Kendall 和 Hammer 受雇于 Zealand Pharma。Weinzimer 从 Zealand Pharma 获得咨询费。