Cardiology Associates of North Mississippi, 499 Gloster Creek Village, Suite A-2, Tupelo, MS, USA.
Albany College of Pharmacy and Health Sciences, Albany, NY, USA.
Am J Cardiovasc Drugs. 2024 Nov;24(6):729-741. doi: 10.1007/s40256-024-00665-1. Epub 2024 Aug 13.
Atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality and morbidity, is associated with a substantial healthcare and economic burden. Reduction of low-density lipoprotein cholesterol (LDL-C) to guideline-recommended goals is crucial in the prevention or management of ASCVD, particularly in those at high risk. Despite the availability of several effective lipid-lowering therapies (LLTs), up to 80% of patients with ASCVD do not reach evidence-based LDL-C goals. This nonattainment may be due to poor adherence to, and lack of timely utilization of, LLTs driven by a range of variables, including polypharmacy, side effects, clinical inertia, costs, and access issues. Inclisiran was approved by the US Food and Drug Administration in 2021 as a novel, twice-yearly, healthcare provider (HCP)-administered LLT. In-office administration allows HCPs more control of drug acquisition, administration, and reimbursement, and may allow for more timely care and increased patient monitoring. In the USA, in-office administered drugs are considered a Medical Benefit and can be acquired and reimbursed using the "buy-and-bill" process. Buy-and-bill is a standard system for medication administration already established in multiple therapeutic areas, including oncology, vaccines, and allergy/immunology. Initiating in-office administration will involve new considerations for clinicians in the cardiovascular specialty, such as the implementation of new infrastructure and processes; however, it could ultimately increase treatment adherence and improve cardiovascular outcomes for patients with ASCVD. This article discusses the potential implications of buy-and-bill for the cardiology specialty and provides a practical guide to implementing HCP-administered specialty drugs in US clinical practice.
动脉粥样硬化性心血管疾病(ASCVD)是导致死亡率和发病率的主要原因,与大量的医疗保健和经济负担有关。降低低密度脂蛋白胆固醇(LDL-C)至指南推荐的目标对于 ASCVD 的预防或管理至关重要,尤其是在高危人群中。尽管有几种有效的降脂治疗(LLT),但高达 80%的 ASCVD 患者未达到基于证据的 LDL-C 目标。这种未达标可能是由于多种因素导致的 LLT 依从性差和未能及时使用,包括多药治疗、副作用、临床惰性、成本和获得问题。依洛尤单抗于 2021 年被美国食品和药物管理局批准为一种新型、每半年一次的医疗保健提供者(HCP)管理的 LLT。在办公室管理允许 HCP 更好地控制药物的获取、管理和报销,并可能允许更及时的护理和增加患者监测。在美国,办公室管理的药物被认为是一种医疗福利,可以通过“购买和计费”流程获得和报销。购买和计费是一种已经在多个治疗领域(包括肿瘤学、疫苗和过敏/免疫学)建立的药物管理标准系统。开始在办公室管理将涉及心血管专业临床医生的新考虑因素,例如实施新的基础设施和流程;然而,它最终可能会提高治疗依从性并改善 ASCVD 患者的心血管结局。本文讨论了购买和计费对心脏病学专业的潜在影响,并提供了在美国临床实践中实施 HCP 管理的专科药物的实用指南。
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