UK market access strategy for AlphaBiomics’ novel precision medicine diagnostic test RxSelex™

** 医疗保健挑战：** 免疫介导的疾病是终身疾病，其特征是身体免疫系统的异常反应，称为炎症。例如克罗恩病（CD）和溃疡性结肠炎（UC）。经历严重疾病的人，其活动无法用常规药物控制，通常用生物药物治疗以阻止炎症。这种类型的药物是由生物体中也发现的材料制成的。通常，患有相同疾病的个体最初用相同类型的生物药物治疗。然而，个体患者对相同生物药物的反应非常不同。有些人可能会受益，而另一些人则不会，或者有不必要的副作用。在2019冠状病毒病大流行期间，这些免疫功能低下的患者持续需要去医院就诊，治疗成功的不确定性尤其困难。**字母组学的解决方案：** 肠道微生物组（我们肠道中典型无害细菌的大型复杂群落）对生物药物反应具有重要影响。AlphaBiomics正在为CD和UC患者开发一种非侵入性的家庭测试，可以预测一个人对生物药物的可能反应。这项名为RxSelex（tm）的测试测量了患者粪便中发现的重要肠道微生物组成分。一旦这种诊断测试准备好使用，它将被出售给NHS。快速项目目标：** 国民保健服务目前正在经历重大变化，在如何规划，获得，支付和提供卫生和保健服务。建立了新的综合保健系统，以便将某一地理区域的国民保健服务提供者和专员与地方当局和其他地方伙伴聚集在一起，共同规划保健和保健服务，以满足区域人口的需要。NHS重组为ICS正在改变采用和订购途径，包括RxSelex（tm）等诊断测试。该项目的目的是为NHS采用和传播适合新ICS结构的RxSelex（tm）制定明确的路线图。**快速工作计划：** AlphaBiomics将聘请专家咨询公司Hardian Health来提供这一路线图。Hardian将审查有关采用和购买诊断测试的公开信息。他们还将估计英国将受益于RxSelex（tm）的IBD患者数量。然后，Hardian将采访专家，以确认或更新他们的发现，然后在路线图中总结结果。

**HEALTHCARE CHALLENGE:** Immune-mediated diseases are lifelong illnesses characterized by an abnormal reaction of the body's immune system, known as inflammation. Examples are Crohn's disease (CD) and ulcerative colitis (UC). People who experience severe disease whose activity cannot be controlled with the usual medication are typically treated with a biologic drug to stop inflammation. This type of medicine is made of materials also found in living organisms. Typically, individuals with the same disease are initially treated with the same type of biologic drug. However, individual patients respond very differently to the same biologic drug. Some may benefit, whereas others do not, or have unwanted side effects. The continued need for hospital visits and uncertainty of treatment success has been especially difficult for these immuno-compromised patients during the COVID-19 pandemic.**ALPHABIOMICS' SOLUTION:** The gut microbiome (the large and complex community of typically harmless bacteria in our intestines) has an important influence over biologic drug response. AlphaBiomics is developing a non-invasive at-home test for CD and UC patients that predicts a person's likely response to biologic drugs as a group. This test, called RxSelex(tm), measures important gut microbiome components found in a patient's stool. Once this diagnostic test is ready for use, it will be sold to the NHS.**FAST PROJECT AIM:** The NHS is currently undergoing major changes in how health and care services are planned, obtained, paid for, and delivered. New Integrated Care Systems (ICSs) have been established to aggregate providers and commissioners of NHS services across a geographical area with local authorities and other local partners to collectively plan health and care services to meet the needs of regional population. NHS reorganisation into ICSs is changing adoption and ordering pathways including for diagnostic tests like RxSelex(tm). The aim of this project is to develop a clear roadmap for NHS adoption and dissemination of RxSelex(tm) that fits the novel ICS structure.**FAST WORK PLAN:** AlphaBiomics will engage the expert consultancy Hardian Health to deliver this roadmap. Hardian will review publicly available information regarding adoption and purchasing of diagnostic tests. They will also estimate the number of IBD patients in the UK who will benefit from RxSelex(tm). Hardian will then interview experts to confirm or update their findings and then summarise the results in a roadmap.