Wurcel Victoria, Perche Olivier, Lesteven Daniel, Williams Doris-Ann, Schäfer Birgit, Hopley Colin, Jungwirth Rebecca, Postulka Anne, Pasmans Raf, Hermansson Lisse-Lotte, Ott Markus, Glorioso Valeria
EDMA, The European Diagnostic Manufacturers Association, Member of MedTech Europe, Brussels, Belgium.
Public Health Genomics. 2016;19(3):137-43. doi: 10.1159/000446531. Epub 2016 Jun 1.
Personalised health care is an evolution, moving away from a disease-focused model of care, translating scientific and technological advances into benefits for patients, and placing them at the centre of the patients' health and care. Companion diagnostics emerge as a very specific and special group of in vitro diagnostics among the different technologies shaping the personalised health care spectrum. Companion diagnostics provide highly valuable information, allowing patients, health practitioners and payers to decide with a higher level of certainty on the potential benefits of a treatment or care pathway. Decreasing uncertainty may result in a more efficient selection of treatments and care, targeted at subpopulations that are most likely to benefit. Companion diagnostics account for a minimal portion of the already small expenditure on in vitro diagnostics (far less than 1% of total health care expenditure), and yet they provide the means to limit inefficient use of health care resources while optimising patient outcomes. It is clear that equal access to personalised health care is still an issue across the EU. One of the most common perceived barriers is affordability. The investment in companion diagnostics can provide long-term value for patients and health care systems, shifting resources to areas of need. Health systems do not fully recognise yet the value that companion diagnostics bring to make personalised health care more affordable across the EU. This inhibits patient access to personalised treatments and care, preventing improved outcomes. In many countries, market access frameworks for diagnostic tests are fragmented and not aligned with specific funding and reimbursement mechanisms, discouraging the use of these tests. Emerging evidence shows that patients are missing out on the appropriate tests and treatments while a reduction in the inefficient use of health care resources is not realised. This article outlines some of these market access barriers for companion diagnostics in the EU, including reimbursement challenges specific to some member states (Germany, the UK, and France). Furthermore, proposals addressing barriers and increasing timely patient access to companion diagnostics in the EU are presented.
个性化医疗是一种演变，它摒弃了以疾病为中心的医疗模式，将科技进步转化为患者的福祉，并将患者置于其健康与医疗的核心位置。伴随诊断在构成个性化医疗领域的不同技术中，成为了一组非常特殊且独特的体外诊断方法。伴随诊断提供了极具价值的信息，使患者、医疗从业者和支付方能够更确定地决定某种治疗或护理途径的潜在益处。不确定性的降低可能会带来更高效的治疗和护理选择，针对最有可能受益的亚群体。伴随诊断在体外诊断已不算高的支出中占比极小（远低于医疗总支出的1%），然而它们却提供了限制医疗资源低效使用同时优化患者治疗效果的手段。显然，在整个欧盟，平等获得个性化医疗仍然是一个问题。最常见的障碍之一是可负担性。对伴随诊断的投资可为患者和医疗系统带来长期价值，将资源转移到有需求的领域。医疗系统尚未充分认识到伴随诊断在使整个欧盟的个性化医疗更具可负担性方面所带来的价值。这抑制了患者获得个性化治疗和护理的机会，阻碍了治疗效果的改善。在许多国家，诊断测试的市场准入框架分散，且与特定的资金和报销机制不一致，这不利于这些测试的使用。新出现的证据表明，患者正在错过适当的测试和治疗，同时医疗资源的低效使用并未得到改善。本文概述了欧盟伴随诊断的一些市场准入障碍，包括一些成员国（德国、英国和法国）特有的报销挑战。此外，还提出了解决障碍并增加欧盟患者及时获得伴随诊断机会的建议。
