University of Groningen Groningen, Netherlands.
Front Pharmacol. 2012 Oct 15;3:181. doi: 10.3389/fphar.2012.00181. eCollection 2012.
Stratified Medicine (SM) has the potential to target patient populations who will most benefit from a therapy while reducing unnecessary health interventions associated with side effects. The link between clinical biomarkers/diagnostics and therapies provides new opportunities for value creation to strengthen the value proposition to pricing and reimbursement (P&R) authorities. However, the introduction of SM challenges current reimbursement schemes in many EU countries and the US as different P&R policies have been adopted for drugs and diagnostics. Also, there is a lack of a consistent process for value assessment of more complex diagnostics in these markets. New, innovative approaches and more flexible P&R systems are needed to reflect the added value of diagnostic tests and to stimulate investments in new technologies. Yet, the framework for access of diagnostic-based therapies still requires further development while setting the right incentives and appropriate align stakeholders interests when realizing long-term patient benefits. This article addresses the reimbursement challenges of SM approaches in several EU countries and the US outlining some options to overcome existing reimbursement barriers for stratified medicine.
分层医学（SM）有可能针对最能从治疗中获益的患者群体，同时减少与副作用相关的不必要的健康干预。临床生物标志物/诊断与治疗之间的联系为价值创造提供了新的机会，以加强对定价和报销（P&R）机构的价值主张。然而，SM 的引入对许多欧盟国家和美国的现行报销方案提出了挑战，因为不同的 P&R 政策已分别针对药物和诊断采用。此外，这些市场缺乏对更复杂诊断进行价值评估的一致流程。需要新的、创新的方法和更灵活的 P&R 系统来反映诊断测试的附加值，并刺激对新技术的投资。然而，基于诊断的治疗方法的准入框架仍需要进一步发展，同时在实现长期患者利益时设定正确的激励措施并适当调整利益相关者的利益。本文探讨了欧盟几个国家和美国在 SM 方法方面的报销挑战，概述了克服分层医学现有报销障碍的一些选择。
