英文【EFPIA】创新药物不可用和获取延迟的根本原因——2025年报告摘要

The root cause of unavailability and delay to innovative medicines: Reducing the time before patients have access to innovative medicinesReport summaryMay 20252ContentsObjective of the analysisFindingsConclusions1233ContentsObjective of the analysisFindingsConclusions1234The report explains the root causes of unavailability of products across European countries The W.A.I.T. Indicators & Root CausesThe root cause of unavailability and delay to innovative medicines – CRA reportEFPIA Patients W.A.I.T. Indicator – IQVIA report•The unprecedented speed of innovation exhibited over the last five years and the promise of the industry pipeline provides an important opportunity to improve outcomes for patients•There is common agreement that the value of innovation is only realised when patients benefit from advances in treatment•However, a significant number of medicines are not available across all European Union (EU) markets•EFPIA has studied this through the W.A.I.T. Indicator Survey for many years and has asked CRA to support an analysis of the root cause of delays in availability of medicines in the EU•This report summarizes the sixth edition of the root cause analysis, first released in June 2020 and used as a basis for discussion with several EU and national policy-makers and stakeholdersFocus of this report5What do we mean by availability and delay?•In the European Union, once a new treatment has gone through a process of research and development lasting ten years on average, three further milestones have to be reached prior to patient access•It is important to distinguish between a number of different time points:1.The length of time between application for and the granting of marketing authorisation2.The length of time from market authorisation to application for price and reimbursement3.The length of time from application for price and reimbursement to decision on value assessment4.The length of time from decision on value assessment to reimbursement decisionTypes of delay in the availability of medicinesSource: CRA analysis6What is the evidence on unavailability and delays?•There is wide variation in time to availability and available across Europe•There is also evidence that shows systematic differences between different types of medicines –The availability of oncology medicines, although remaining higher than for all medicines, has decreased over time–For orphan medicines, the rate of availability remains consistently lower, with long delays and low rates of availability in CEE and Southern Europe•Even within one country, patients can get access to some medicines almost immediately, and wait years for others•Across all innovative medicines, there is little evidence that delays are reducing – in fact the contraryComparing availability across European countries1Sources: [1] Patient W.A.I.T. Indicator 2024 Survey60-80%>80%20-40%40-60%10-20%<10%24%18%16%60%37%50%50%82%50%27%8%3%19%53%27%27%61%39%9% 9%83%60%73%90%58%58%51%71%54%61%31%43%36%10%7Con