2025年欧洲障碍门户网站-报告摘要

European Access Hurdles Portal:Summary of the thirdexternal report May2025 Theindustry created the European Access Hurdles Portal to add newinformation to the debate on availability of innovative medicines Created in April 2022, the role of the Portal is toimprove transparency regarding the root causes of unavailability and delay, including the role ofthe environment and its corresponding impact on commercial decision-making Results indicate a complete willingness from industry to provide moretransparency on the root causes of unavailability Industry participation Data completeness and representativeness Therapy areas of products included in thePortal dataset between Jan 2021-Jun 2024 Therapy areas of products approved bythe EMA between Jan 2021-Jun 2024 Data on94 productswere submitted to thePortal. All received European marketing authorisationbetween January 2021 and June 2024. All35EFPIA member companies with eligibleproducts submitted data to the Portal (100%participation) The analysis described in this report istherefore representative of100% of allproductsapproved by the EMA betweenJanuary 2021 and June 2024 that aremarketed by EFPIA members The therapy areas of Portal products and the composition ofproducts approved by the EMA over the same time period are similar–suggesting the products within the Portal arerepresentativeof thetypes of innovative medicines approved by the EMA over this period This report presents an updated analysis focusing on a set of keyresearch questions The products in-scope of the Portal received marketing authorisationlater in Europe than in the US and Japan Key findings: Speed of marketing authorisation Date of EMA approvals relative to the US, UK, Japan and China •Of all new products approved by international regulatorsbetween January 2021 and June 2024,EMA approval camelater, on average, than the US and by Japan by 252 daysand 24 days respectively; this represents the comparativespeed of EMA approvals improving since the 2024 report oForoncology drugs,EMA approval happened, onaverage, 69 days earlier than in Japan and 303 dayslater than in the US. This represents a positive trendversus 2024, where EMA approval came 204 days afterPMDA oFororphan products, EMA approval comes 312 daysafter the US, and 95 days after Japan •This shows that even before considering the P&R process,Europe is slower in approving new productsthan theregulatory agencies in other regions1 In many instances of product unavailability, the products have in factbeen filed for reimbursement but have not yet been reimbursed Key findings: Status of filing and reimbursement •To truly understandpatient access, we must considerfiling,availabilityandaccessibility through alternative accessschemes (AAS)* oTaking an average across European countries,67%ofproducts have either been filed for P&R or madeaccessible through an AAS •Focusing on the formal P&R channel, looking at all products inthe Portal to date (which covers products that are on average25 months post-marketingauthorisation): oTaking an average across European countries,59%ofproducts have been filedfor P&R. Of which: ▪55%of filed products have been reimbursed▪37%of filed products are pending areimbursement decision▪7%have had a negative decision or beenwithdrawn •The both the total percentage and the relative proportion ofproducts that have been filed for P&R or made accessiblethrough an AASvaries significantlybased ongeography When following a cohort of products over time, there is an increase inthe rate of filing, availability and accessibility Change in rate of product filing, availability and accessibility across countriesand over time Key findings: Status of filing and reimbursement •By investigating the current statusof the 66productsincluded in the 2024 Portal Report wecan understand the impact of time on the rate offiling, availability and accessibility •There has been a5% increasein the rate offiling and accessibility via an AAS from at32-months post MA (vs 20-months previously) •This is largely driven by anincrease in theproportion of products filed for P&Rthat werepreviously inaccessible •The level of change varies significantlyacross Europe oConsidering the countries with the biggestchanges, Romania and Greece, havecountry filing requirements, the portalunderlines this is a significant factorcontributing to delays in some countries While there are delays in P&R filing in for some products, this is not akey driver of low availability of medicines in all countries Key findings: Speed of filing and reimbursement Time to file for P&R as proportion of the total time until reimbursement following EMAmarketingauthorisation •Although the Portal contains products that havebeen on the market for different lengths of time,across products that have been successfullyreimbursed: o31%(or an average of 163 days)of thetotal time between EMA approval andavailability can be attributed to the timebetween receiving EMA m