University of Florida College of Pharmacy, Gainesville, FL.
University of Florida College of Pharmacy, Gainesville, FL.
Clin Ther. 2024 Mar;46(3):289-292. doi: 10.1016/j.clinthera.2023.12.014. Epub 2024 Feb 2.
Glucagon-like peptide 1 receptor agonists (GLP1-RA) are effective therapies in lowering glycosylated hemoglobin (HbA), providing cardioprotective benefits, and lowering weight. The use of GLP1-RA solely for weight-loss has become commonplace in many practices, which in turn has made it difficult in some areas for those with type 2 diabetes (T2DM) to obtain these much-needed medications.
Using recent published literature, along with clinical experience, it has become apparent that many GLP1-RAs have become difficult to obtain for patients with diabetes.
Many clinicians started to prescribe the brand Ozempic® (semaglutide*) and dulaglutide for weight loss despite neither of them being Food and Drug Administration (FDA) approved for this indication. Ozempic, having outperformed dulaglutide in in both HbA reduction and weight loss, along with FDA approval of semaglutide for weight loss, has quickly become widely used off-label for weight loss. This off-label use may have increased, despite the approval of semaglutide, because many insurances will not cover semaglutide solely for weight management. Most recently, Eli Lilly was able to develop tirzepatide, which was FDA approved in May of 2022, and they are seeking fast-track FDA approval for weight loss and are projected to gain this approval within 2023.
Insurance coverage for weight management remains sparse, and obtaining these therapies for diabetes has now become more burdensome, with insurance companies requiring a prior authorization proving FDA-approved diagnosis of T2DM. Hopefully, should more GLP1-Ras receive approval for weight loss, along with an increase in insurance coverage, the burden on patients with diabetes will be lessened as they are able to quickly obtain this highly effective therapy.
胰高血糖素样肽 1 受体激动剂(GLP1-RA)在降低糖化血红蛋白(HbA)、提供心脏保护益处和降低体重方面非常有效。在许多实践中,GLP1-RA 仅用于减肥已经变得很普遍,这反过来又使得一些 2 型糖尿病(T2DM)患者在某些地区难以获得这些急需的药物。
使用最近发表的文献和临床经验,很明显,许多 GLP1-RA 已经变得难以获得糖尿病患者。
许多临床医生开始开处方品牌 Ozempic®(司美格鲁肽*)和度拉糖肽用于减肥,尽管它们都没有获得美国食品和药物管理局(FDA)对此适应症的批准。Ozempic 在 HbA 降低和体重减轻方面均优于度拉糖肽,并且 FDA 批准司美格鲁肽用于减肥,因此已迅速被广泛用于减肥的标签外使用。尽管获得了司美格鲁肽的批准,但这种标签外的使用可能会增加,因为许多保险公司不会仅为体重管理而承保司美格鲁肽。最近,礼来公司成功开发了替西帕肽,该药物于 2022 年 5 月获得 FDA 批准,他们正在寻求快速通道 FDA 批准用于减肥,并预计在 2023 年内获得批准。
体重管理的保险覆盖仍然稀疏,并且由于保险公司要求提供事先授权,证明患有 T2DM 的 FDA 批准诊断,因此获得这些糖尿病治疗方法的负担现在更加沉重。希望随着更多的 GLP1-Ras 获得减肥批准以及保险覆盖范围的增加,糖尿病患者的负担将会减轻,因为他们能够快速获得这种高效的治疗方法。