IQVIA, RWS, Paris, France.
IQVIA, RWS, Paris, France.
J Cardiol. 2022 Jul;80(1):72-79. doi: 10.1016/j.jjcc.2021.10.009. Epub 2021 Nov 10.
A patent foramen ovale (PFO) is formed when the ovale foramen does not close spontaneously or re-opens leaving the right and left atrium connected. The present study was conducted to analyze the cost-effectiveness of PFO closure with Amplatzer device plus medical therapy (MT) compared to MT alone in the French reimbursement system for PFO patients with a prior history of stroke, using the RESPECT study data.
A multi-state Markov model was used. The analysis was conducted from a collective perspective over a 10-year time horizon with 4% discount applied for costs and health effects. The simulated population included adult patients with PFO. Sub-group analysis was limited to patients with atrial septal aneurysm and/or a large-shunt. Clinical inputs were derived from the RESPECT study and literature. Costs associated with the device, drugs, and management were sourced from literature and national databases. The outcomes of analyses included life-years (LYs), quality-adjusted LYs (QALYs), incremental cost-effectiveness ratio (ICER), and number of recurrent strokes avoided. Scenario and sensitivity analyses were conducted to assess the robustness of the results.
The use of Amplatzer plus MT provided additional QALYs (0.16) at an incremental cost of 7301€, generating an ICER of 46,288€/QALY for Amplatzer vs. MT alone. In the sub-group analysis, Amplatzer plus MT provided additional QALYs (0.20) at an incremental cost of 5818€, generating an ICER of 28,624€/QALY for Amplatzer plus MT vs. MT alone. Amplatzer plus MT led to lower number of recurrent strokes in comparison to MT alone in both populations. Scenario and sensitivity analyses confirmed the robustness of the results.
Amplatzer plus MT represents a cost-effective treatment option and is associated with lower stroke recurrence compared to MT alone for PFO patients with a prior history of stroke.
卵圆孔未闭（PFO）是由于卵圆孔未能自发闭合或重新开放，使左右心房相通而形成的。本研究旨在分析在法国 PFO 患者的报销体系中，使用 Amplatzer 封堵器加药物治疗（MT）与单独 MT 相比的成本效益，该体系中的 PFO 患者既往有卒中病史，研究数据来源于 RESPECT 研究。
采用多状态马尔可夫模型。分析从 10 年的时间跨度进行，从集体角度进行，成本和健康效果应用 4%的贴现率。模拟人群包括 PFO 成年患者。亚组分析仅限于房间隔瘤和/或大分流患者。临床数据来源于 RESPECT 研究和文献。与器械、药物和管理相关的成本来源于文献和国家数据库。分析结果包括生命年（LYs）、质量调整生命年（QALYs）、增量成本效益比（ICER）和避免的复发性卒中数。进行了情景和敏感性分析以评估结果的稳健性。
Amplatzer 加 MT 的使用提供了额外的 0.16 个 QALYs（质量调整生命年），而增量成本为 7301 欧元，产生的 Amplatzer 与 MT 单独使用相比的增量成本效益比（ICER）为 46288 欧元/QALY。在亚组分析中，Amplatzer 加 MT 提供了额外的 0.20 个 QALYs（质量调整生命年），而增量成本为 5818 欧元，产生的 Amplatzer 加 MT 与 MT 单独使用相比的增量成本效益比（ICER）为 28624 欧元/QALY。Amplatzer 加 MT 与 MT 单独使用相比，在两种人群中都降低了复发性卒中的数量。情景和敏感性分析证实了结果的稳健性。
Amplatzer 加 MT 是一种具有成本效益的治疗选择，与单独 MT 相比，可降低 PFO 患者既往有卒中病史的复发性卒中的发生风险。
