LaPensee Kenneth, Mistry Rohit, Lodise Thomas
Director, Health Economics and Outcomes Research, Paratek Pharmaceuticals, Inc, King of Prussia, PA.
Senior Associate, Health Economics, PAREXEL Access Consulting, PAREXEL International, London, UK.
Am Health Drug Benefits. 2019 Feb;12(1-Supplement 2):S13-S24.
Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). It has broad-spectrum activity against common causative pathogens of ABSSSI, including methicillin-resistant . Omadacycline has been shown to be noninferior to linezolid for the treatment of adults with ABSSSI across 2 phase 3 clinical trials. To date, no studies have assessed the budget impact for omadacycline in the treatment of ABSSSI.
To estimate the potential budget impact of introducing omadacycline as a treatment option in patients who present to the emergency department (ED) with ABSSSI from the hospital perspective (Medicare payer) in the United States. The ED's and observation units were assumed to be hospital-owned.
The base case of this decision model-based analysis was conducted from the perspective of a hospital for a theoretical cohort of 1 million covered Medicare members over a 3-year time horizon. Scenario analyses included the economic impact of (1) shifting inpatient care to the outpatient setting with omadacycline and (2) reducing hospital length of stay (LOS) among hospitalized patients with omadacycline IV to oral therapy relative to the current inpatient standard of care. Costs are presented in 2017 US dollars with no adjustments for inflation, based on the cost model estimates.
The annual total incremental cost following the introduction of omadacycline as a treatment of ABSSSI was $11,168, $39,918, and $88,777 in years 1, 2, and 3, respectively. The incremental cost per member treated (cost per case) rose by $0.49, $1.74, and $3.86 over 3 years. Reducing hospital LOS by 1 day among hospitalized patients with omadacycline resulted in incremental costs of $4311, $15,231, and $33,919 in years 1, 2, and 3, respectively. Under the assumption that patients may be discharged sooner when an oral formulation of the same drug with which they are being treated is available, reducing hospital LOS by 2 days reduced costs by $2546, $9455, and $20,939 in years 1, 2, and 3, respectively. Shifting inpatient care to the outpatient setting with omadacycline reduced costs by $38,777, $139,885, and $310,784 in years 1, 2, and 3, respectively.
This hypothetical, model-based study determined that omadacycline would result in a modest increase in total cost over 3 years when introduced as a treatment for ABSSSI in adults who present to the ED for their care.
奥马环素是一种口服和静脉注射(IV)的每日一次氨基甲基环素类抗生素,在美国被批准用于治疗患有急性细菌性皮肤和皮肤结构感染(ABSSSI)的成人患者。它对ABSSSI的常见致病病原体具有广谱活性,包括耐甲氧西林菌。在两项3期临床试验中,奥马环素已被证明在治疗患有ABSSSI的成人患者方面不劣于利奈唑胺。迄今为止,尚无研究评估奥马环素治疗ABSSSI的预算影响。
从美国医院角度(医疗保险支付方)估计将奥马环素作为治疗选择引入到因ABSSSI就诊于急诊科(ED)的患者中的潜在预算影响。假设ED和观察病房为医院所有。
基于决策模型的本分析的基础病例是从一家医院的角度,针对理论上100万参保医疗保险成员的队列,在3年时间范围内进行的。情景分析包括:(1)使用奥马环素将住院治疗转移到门诊环境的经济影响;(2)相对于当前住院标准治疗,使用奥马环素IV至口服疗法减少住院患者的住院时间(LOS)。根据成本模型估计,成本以2017年美元呈现,未作通胀调整。
在第1年、第2年和第3年,引入奥马环素治疗ABSSSI后的年度总增量成本分别为11,168美元、39,918美元和88,777美元。在3年中,每例治疗成员的增量成本(每例成本)分别增加了0.49美元、1.74美元和3.86美元。使用奥马环素使住院患者的住院LOS减少1天,在第1年、第2年和第3年分别导致增量成本4311美元、15,231美元和33,919美元。假设当患者可获得正在使用的同一药物的口服制剂时可更早出院,使用奥马环素使住院LOS减少2天,在第1年、第2年和第3年分别使成本降低2546美元、9455美元和20,939美元。使用奥马环素将住院治疗转移到门诊环境,在第1年、第2年和第3年分别使成本降低38,777美元、139,885美元和310,784美元。
这项基于模型的假设性研究确定,当将奥马环素作为治疗选择引入到因ABSSSI就诊于ED进行治疗的成人患者中时,在3年内总成本将适度增加。