LaPensee Ken, Lodise Thomas
Director, Health Economics and Outcomes Research, Paratek Pharmaceuticals, King of Prussia, PA.
Professor, Albany College of Pharmacy and the Health Sciences, NY.
Am Health Drug Benefits. 2018 Dec;11(9):449-459.
Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that was recently approved by the US Food and Drug Administration for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). In 2 phase 3 clinical trials, IV-to-oral switch and oral-only administration of omadacycline achieved the primary end points of noninferiority compared with linezolid in treating patients with ABSSSI.
To estimate the potential cost-savings with bioequivalent IV-to-oral antibiotics, such as omadacycline, compared with the standard of care with IV vancomycin by avoiding hospitalizations and reducing hospital stays in patients presenting from the emergency department for ABSSSI treatment.
We used hospital avoidance models to examine the potential cost-savings of managing patients with ABSSSI and no or limited comorbidities and without life-threatening conditions by using omadacycline in the outpatient setting compared with the current standard of care. Early hospital discharge models were used to evaluate the hospital stay reduction that would be required to be achieved with omadacycline treatment relative to IV vancomycin to confer cost-savings compared with standard of care among patients with ABSSSI and ≥2 comorbidities but no life-threatening conditions.
In the hospital stay avoidance models, cost-savings may be realized by using therapeutically bioequivalent IV-to-oral antibiotics, such as omadacycline, compared with inpatient treatment with IV vancomycin. Based on a sensitivity analysis, further savings could be possible with outpatient administration of omadacycline, even if 20% of omadacycline outpatients were subsequently admitted and incurred the full inpatient cost, with no reimbursement penalties. Of more than 300 patients, only 1 was admitted to the hospital after a full course of omadacycline in the oral-only clinical trial. In the early hospital discharge models, the maximum cost-minimizing daily expense of omadacycline varied from $173 to $936, depending on the presence of active comorbidities or systemic symptoms, hospital stay reduction, and model perspective.
These results suggest that the targeted use of antibiotics with bioequivalent IV-to-oral formulations, such as omadacycline, for select patients with ABSSSI may lead to cost-savings compared with inpatient IV vancomycin treatment by shifting care to the outpatient setting or by facilitating earlier hospital discharge among hospitalized patients.
奥马环素是一种口服和静脉注射（IV）每日一次的氨甲基环素类抗生素，最近被美国食品药品监督管理局批准用于治疗急性细菌性皮肤和皮肤结构感染（ABSSSI）患者。在两项3期临床试验中，奥马环素从静脉注射转换为口服给药以及仅口服给药在治疗ABSSSI患者方面与利奈唑胺相比达到了非劣效性的主要终点。
通过避免住院和缩短急诊科就诊接受ABSSSI治疗患者的住院时间，评估与静脉注射万古霉素这种标准治疗方法相比，使用生物等效的静脉注射转口服抗生素（如奥马环素）可能节省的成本。
我们使用避免住院模型来研究，与当前标准治疗方法相比，在门诊环境中使用奥马环素治疗无合并症或合并症有限且无危及生命情况的ABSSSI患者可能节省的成本。使用早期出院模型来评估，相对于静脉注射万古霉素，奥马环素治疗需要实现的住院时间缩短幅度，以便在患有ABSSSI且合并症≥2种但无危及生命情况的患者中与标准治疗方法相比实现成本节省。
在避免住院时间模型中，与静脉注射万古霉素的住院治疗相比，使用治疗上生物等效的静脉注射转口服抗生素（如奥马环素）可能实现成本节省。基于敏感性分析，即使20%的奥马环素门诊患者随后入院并产生全部住院费用且无报销处罚，门诊使用奥马环素仍可能进一步节省成本。在300多名患者中，仅口服奥马环素的临床试验中有1名患者在完成整个疗程后入院。在早期出院模型中，奥马环素使成本最小化的每日最高费用从173美元到936美元不等，这取决于是否存在活动性合并症或全身症状、住院时间缩短情况以及模型视角。
这些结果表明，对于部分ABSSSI患者，有针对性地使用具有生物等效静脉注射转口服制剂的抗生素（如奥马环素），与住院静脉注射万古霉素治疗相比，通过将护理转移到门诊环境或促进住院患者更早出院，可能会节省成本。
