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导航和推进体外诊断的市场准入:了解关键利益相关者和政策制定者的角色

Brandon K Hill¹, Andrea M Prinzi¹, J R Kane²

¹US Medical Affairs, bioMérieux, Salt Lake City, Utah, USA.

Open forum infectious diseases

|October 24, 2025

概括

应对市场准入挑战对于广泛采用传染病诊断至关重要. 通过以证据为基础的宣传与政策制定者和付款人进行接触是改善患者获得重要诊断技术的关键.

科学领域:

临床诊断临床诊断临床诊断
卫生政策和市场准入
抗微生物耐药性抗微生物耐药性

背景情况:

快速而准确的传染病诊断对于抗微生物药物管理和患者的治疗结果至关重要.
采用体外诊断 (IVD) 的障碍包括高成本,不一致的报销和监管障碍.
市场准入,卫生政策和倡导活动显著影响患者的诊断技术可用性.

研究的目的:

提供关于体外诊断器 (IVD) 市场准入过程的概述.
突出各种利益相关者对诊断可访问性的影响.
强调需要协调,以证据为基础的参与,以推进IVD采用.

主要方法:

审查市场准入流程的关键组成部分:监管途径,覆盖范围,报销,证据生成和利益相关方参与.
分析医疗保健提供者,支付者,患者和决策者的角色.
强调临床医生,药剂师和实验室专业人员倡导的重要性.

主要成果:

了解市场准入格局对于克服新诊断的采用障碍至关重要.
医疗保健专业人员积极参与政策和宣传工作对于影响监管和补偿至关重要.
协调的沟通策略是必要的,以有效地与监管机构,付款人和专业协会进行互动.

结论:

推进体外诊断的可访问性需要与市场准入组件的战略参与.
临床和实验室专业人员基于证据的宣传对于成功的政策和报销至关重要.
利益相关者之间的合作对于确保患者及时获得创新的诊断解决方案至关重要.

关键词:

倡导活动倡导活动卫生政策卫生政策在体外诊断 in vitro诊断传染病诊断诊断传染病诊断进入市场的市场准入权.

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