REBYOTA™（粪便微生物群，活体-jslm[FMBL]）与标准护理预防美国复发性艰难梭菌感染的成本效益分析。

Cost-Effectiveness Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) Versus Standard of Care for the Prevention of Recurrent Clostridioides difficile Infection in the USA.

机构信息

Albany College of Pharmacy and Health Sciences, Albany, NY, USA.

HEOR & RWE, Medical Affairs, Ferring Pharmaceuticals, Inc., 100 Interpace Parkway, Parsippany, NJ, 07054, USA.

出版信息

Adv Ther. 2023 Jun;40(6):2784-2800. doi: 10.1007/s12325-023-02505-1. Epub 2023 Apr 24.

DOI:10.1007/s12325-023-02505-1

PMID:37093359

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10220097/

Abstract

INTRODUCTION

Recurrent Clostridioides difficile infection (rCDI) is common and associated with considerable clinical and economic consequences. REBYOTA™ (fecal microbiota, live-jslm [FMBL]) is a microbiota-based live biotherapeutic approved for the prevention of rCDI following antibiotic treatment for rCDI. We sought to evaluate cost-effectiveness of FMBL compared to standard of care (SOC) from a US third-party payer perspective among patients with one or more (≥ 1) recurrences.

METHODS

A Markov model with a lifetime time horizon was developed. The model population included adult patients who had ≥ 1 recurrence after a primary CDI episode and had completed ≥ 1 round of antibiotics, or had ≥ 2 severe CDI episodes resulting in hospitalization within the last year. The model consisted of six health states with an 8-week model cycle: rCDI, absence of CDI after recurrence, colectomy, ileostomy, ileostomy reversal, and death. Drug costs and rCDI-related medical costs were estimated in 2022 US dollars and discounted at 3% annually. Deterministic sensitivity analyses were performed.

RESULTS

Compared to SOC, FMBL at $9000/course resulted in an incremental cost-effectiveness ratio (ICER) of $18,727 per quality-adjusted life year (QALY) gained. The incremental cost was $5336 (FMBL $79,236, SOC $73,900) and the incremental effectiveness was 0.285 QALYs (FMBL 10.346, SOC 10.061). The cumulative drug acquisition and administration costs for the FMBL and SOC arms were $24,245 and $16,876, while rCDI-related medical costs for FMBL and SOC were $54,991 and $57,024, respectively. The ICER in the subgroup of patients at first recurrence was $13,727 per QALY gained. FMBL remained cost-effective across all sensitivity analyses.

CONCLUSIONS

FMBL was found to be cost-effective compared to SOC for the prevention of rCDI with more benefits among patients at first recurrence, with an ICER far below the payer ICER threshold of $100,000. Patients treated with FMBL experienced higher total QALYs and reduced healthcare resource utilization, including reduced hospitalizations.

摘要

简介

复发性艰难梭菌感染（rCDI）很常见，并且与相当大的临床和经济后果相关。REBYOTA™（粪便微生物群，活 JSLM[FMBL]）是一种基于微生物组的活生物疗法，批准用于预防 rCDI，用于 rCDI 后的抗生素治疗。我们从美国第三方支付者的角度评估了 FMBL 与标准护理（SOC）相比在≥1 次复发的患者中的成本效益。

方法

开发了一个具有终生时间范围的马尔可夫模型。模型人群包括在原发性 CDI 发作后有≥1 次复发且完成了≥1 轮抗生素治疗的成年患者，或在过去一年中有≥2 次严重 CDI 发作导致住院的患者。该模型由六个健康状态组成，模型周期为 8 周：rCDI、复发后无 CDI、结肠切除术、回肠造口术、回肠造口术逆转和死亡。药物成本和 rCDI 相关医疗成本按 2022 年的美元计算，并以每年 3%的速度贴现。进行了确定性敏感性分析。

结果

与 SOC 相比，FMBL 每疗程 9000 美元的增量成本效果比（ICER）为每获得 1 个质量调整生命年（QALY）增加 18727 美元。增量成本为 5336 美元（FMBL 79236 美元，SOC 73900 美元），增量效果为 0.285 QALY（FMBL 10.346，SOC 10.061）。FMBL 和 SOC 臂的累积药物获得和管理成本分别为 24245 美元和 16876 美元，而 FMBL 和 SOC 的 rCDI 相关医疗费用分别为 54991 美元和 57024 美元。首次复发患者亚组的 ICER 为每获得 1 个 QALY 增加 13727 美元。在所有敏感性分析中，FMBL 均保持成本效益。