Wilson Michele, Golan Yoav, Nguyen Dianne, Yazdani Morteza, Amin Alpesh N
RTI Health Solutions, Research Triangle Park, NC, USA.
Tufts Medical Center, Boston, MA, USA.
Infect Dis Ther. 2025 Jul 9. doi: 10.1007/s40121-025-01169-4.
Fecal microbiota spores, live-brpk (hereafter VOS) is a microbiota-based orally administered therapeutic approved by the United States Food and Drug Administration for prevention of recurrent Clostridioides difficile infection (rCDI) following standard-of-care (SoC) antibiotics for the treatment of rCDI in patients aged ≥ 18 years. The study objective was to estimate the budget impact of introducing VOS within a hypothetical United States (US) health plan.
A model was developed estimating the health plan budget impact of adding VOS to SoC compared with SoC alone for rCDI. Input data were from the published literature. Uptake of VOS was assumed at 10%, 20%, 30%, and 40% for recurrences 1 through 4, respectively. Annual and per-member per-month (PMPM) costs (2023 US dollars) were estimated from a health plan perspective. Scenario analyses considered different VOS uptake rates and use of fecal microbiota, live-jslm (hereafter RBL).
Including VOS on a formulary for rCDI was found to reduce overall annual costs in a 1-million-member commercial plan by US$42,328. VOS increased pharmacy costs (US$0.0820 PMPM), and these pharmacy costs were offset by other medical cost savings (-US$0.0856 PMPM) such that including VOS on a formulary was cost-saving at US$0.0035 PMPM. With these cost savings, introducing VOS prevented an estimated 27 recurrences among 225 individuals with rCDI. Scenario analyses indicated greater and/or earlier VOS uptake generates more cost savings owing to recurrence prevention, and that VOS was more cost-saving than RBL.
Treatment with VOS is anticipated to reduce recurrences and health plan costs for those with rCDI. Using VOS earlier is expected to increase cost savings. Graphical abstract available for this article.
粪便微生物群孢子，即活布拉氏酵母菌（以下简称VOS），是一种基于微生物群的口服疗法，已获美国食品药品监督管理局批准，用于预防18岁及以上复发性艰难梭菌感染（rCDI）患者在接受标准护理（SoC）抗生素治疗rCDI后再次感染。本研究的目的是评估在美国一个假设的健康计划中引入VOS的预算影响。
建立了一个模型，估计与仅使用SoC治疗rCDI相比，在SoC基础上增加VOS对健康计划预算的影响。输入数据来自已发表的文献。假设第1至4次复发时VOS的使用率分别为10%、20%、30%和40%。从健康计划的角度估计年度和人均每月（PMPM）成本（2023年美元）。情景分析考虑了不同的VOS使用率以及粪便微生物群活酵母菌（以下简称RBL）的使用情况。
在一个拥有100万成员的商业计划中，将VOS纳入rCDI的处方集可使年度总成本降低42,328美元。VOS增加了药房成本（PMPM为0.0820美元），而这些药房成本被其他医疗成本节省（-PMPM为0.0856美元）所抵消，因此将VOS纳入处方集可节省成本，PMPM为0.0035美元。通过这些成本节省，引入VOS可预防225例rCDI患者中的约27例复发。情景分析表明，更高和/或更早地使用VOS由于预防复发而能节省更多成本，且VOS比RBL更具成本效益。
预计VOS治疗可减少rCDI患者的复发率并降低健康计划成本。更早使用VOS有望增加成本节省。本文提供了图形摘要。
