Lopes Renato D, Berger Samantha E, Di Fusco Manuela, Kang Amiee, Russ Cristina, Afriyie Abena, Earley Amy, Deshpande Sohan, Mantovani Lorenzo G
Division of Cardiology, Duke University Medical Center and Duke Clinical Research Institute, 200 Morris Street, Durham, NC 2770, USA.
Meta Research, Evidera, 500 Totten Pond Rd. 5th Floor, Waltham, MA 02451, USA.
Int J Cardiol. 2020 Nov 15;319:85-93. doi: 10.1016/j.ijcard.2020.06.061. Epub 2020 Jul 4.
This review assessed global health technology assessment (HTA) reports and recommendations of non-vitamin K oral anticoagulants (NOACs) in non-valvular atrial fibrillation (NVAF).
NHTA agency websites were searched for HTA reports evaluating NOACs versus NOACs or vitamin K antagonists. HTA methods and information on patient involvement/access were collected and empirically analyzed.
The review identified 38 unique HTA reports published between 2012 and 2017 in 16 countries including 11 in Europe. NOACs that were cost-effective per local willingness-to-pay (WTP) thresholds were positively recommended for the treatment of NVAF. WTP thresholds ranged from €20,000 to 69,000. Apixaban was recommended in 10/12 (83%) countries, dabigatran in 9/13 (69%) countries, and rivaroxaban in 10/13 (76%) over warfarin. Edoxaban was recommended in 5/7 (71%) countries. Economic evaluations and recommendations comparing NOACs were sparse (two or three countries per NOAC) and generally favored apixaban and edoxaban, followed by dabigatran. Eleven HTA reports from four countries considered the patient voice (Canada [n = 3], Scotland [n = 3], England [n = 4], Brazil [n = 1]); however, only 2/11 (18%) developed recommendations based on this. Among the reports with a positive recommendation, 26/30 (87%) featured a decision that aligned with the approved regulatory label.
Most agencies recommended NOACs over warfarin for patients with NVAF. Few countries made statements recommending one NOAC over another. Given different WTP thresholds, a drug that is cost-effective in one market may not be in another. Therefore, the various NOAC recommendations from HTA agencies cannot be generalized across different countries.
本综述评估了全球卫生技术评估（HTA）报告以及非维生素K口服抗凝剂（NOACs）用于非瓣膜性心房颤动（NVAF）的建议。
检索国家卫生技术评估（NHTA）机构网站，查找评估NOACs与其他NOACs或维生素K拮抗剂对比的HTA报告。收集HTA方法以及关于患者参与/获取的信息并进行实证分析。
该综述确定了2012年至2017年间在16个国家发表的38份独特的HTA报告，其中11份来自欧洲。根据当地支付意愿（WTP）阈值具有成本效益的NOACs被积极推荐用于NVAF的治疗。WTP阈值从20,000欧元到69,000欧元不等。在12个国家中的10个（83%）推荐阿哌沙班，在13个国家中的9个（69%）推荐达比加群，在13个国家中的10个（76%）推荐利伐沙班优于华法林。在7个国家中的5个（71%）推荐依度沙班。比较NOACs的经济评估和建议较少（每种NOACs有两三个国家），并且一般倾向于阿哌沙班和依度沙班，其次是达比加群。来自四个国家的11份HTA报告考虑了患者意见（加拿大[n = 3]、苏格兰[n = 3]、英格兰[n = 4]、巴西[n = 1]）；然而，只有2/11（18%）基于此制定了建议。在具有积极建议的报告中，26/30（87%）的决策与批准的监管标签一致。
大多数机构推荐NOACs用于NVAF患者而非华法林。很少有国家发表声明推荐一种NOACs优于另一种。鉴于不同的WTP阈值，在一个市场具有成本效益的药物在另一个市场可能并非如此。因此，HTA机构的各种NOACs建议不能在不同国家一概而论。
