Al-Subhi Abrar, Khan Mansoor Ahmed, Aseeri Mohammed A
Pharmaceutical Care Department, King Abdul-Aziz Medical City-Western Region, King Abdullah International Medical Research Center/King Saud bin Abdulaziz University for Health Sciences, Jeddah, Kingdom of Saudi Arabia.
Glob J Qual Saf Healthc. 2020 May 26;3(2):38-43. doi: 10.36401/JQSH-19-41. eCollection 2020 May.
Medication-use evaluation (MUE) is a performance improvement method used to achieve optimal patient outcomes. The recombinant human factor VIIa (rFVIIa) (NovoSeven) is an expensive agent approved by the U.S. Food and Drug Administration (FDA) for specific indications. However, in clinical practice, rFVIIa is often used for conditions unrelated to the one approved, with limited evidence. The use of rFVIIa has been associated with expenditures of more than Saudi riyal (SR)30 million ($8 million) annually at King Abdul-Aziz Medical City-Western Region (KAMC-WR). Therefore, we planned a MUE of rFVIIa. The primary purpose was to determine the off-label use of rFVIIa, and the secondary purpose was to evaluate the cost impact of off-label use of rFVIIa at KAMC-WR.
This was an observational retrospective cohort study conducted to assess the off-label usage pattern and the direct cost of rFVIIa for one year.
A total of 27 patients who received rFVIIa were included. Two out of the 27 patients had hemophilia A with inhibitors (7%), and 23 of the 27 patients received rFVIIa with off-label indications (85%). The total cost associated with the use of rFVIIa was SR18.61 million ($4.96 million). The cost of the rFVIIa used for the appropriate purpose was SR17.83 million ($4.75 million), which represented 95.8% of the expenditures.
Recombinant FVIIa is one of the most expensive medications in our hospital. It has been used mostly in patients having hemophilia A with inhibitors.
用药评估（MUE）是一种用于实现最佳患者治疗效果的绩效改进方法。重组人凝血因子VIIa（rFVIIa）（诺其）是一种经美国食品药品监督管理局（FDA）批准用于特定适应症的昂贵药物。然而，在临床实践中，rFVIIa常被用于未经批准的适应症，且证据有限。在阿卜杜勒-阿齐兹国王医疗城西部地区（KAMC-WR），rFVIIa的使用每年导致超过3000万里亚尔（800万美元）的支出。因此，我们计划对rFVIIa进行用药评估。主要目的是确定rFVIIa的超说明书用药情况，次要目的是评估KAMC-WR地区rFVIIa超说明书用药的成本影响。
这是一项观察性回顾性队列研究，旨在评估rFVIIa一年的超说明书用药模式和直接成本。
共有27例接受rFVIIa治疗的患者纳入研究。27例患者中有2例患有血友病A并伴有抑制物（7%），27例患者中有23例接受了超说明书适应症的rFVIIa治疗（85%）。使用rFVIIa的总成本为1861万里亚尔（496万美元）。用于适当适应症的rFVIIa成本为1783万里亚尔（475万美元），占支出的95.8%。
重组凝血因子VIIa是我院最昂贵的药物之一。它主要用于患有血友病A并伴有抑制物的患者。
