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European Access Hurdles Portal: Results from thethirdyear of data collection May2025Reviseddraft Executivesummary n April 2022, EFPIA and its members committed to a series of actions designed to reducedisparities in accessacross Europe.TheEuropean Access HurdlesPortal(the “Portal”) waslaunched then as an industry-led initiative toincreasetransparency regarding the root causes ofunavailabilityofinnovative medicines in Europe—a key issue affecting patientaccess toinnovative medicines. It is intended to identifyand report onthemultifactorialroot causes ofdelays in pricing and reimbursement (P&R) filing or the reimbursement decision-making processfor European Union (EU) centrally approved medicinesin their first indication. This allows dataondelayandlackofavailabilitytobeputintocontextandtherebysupportsasharedunderstanding oftheseroot causesandthecollective responsibility to address theseissues. ThePortal can be used to supporta multi-stakeholder dialogue to devise solutions that can addressthese challenges holistically. This is the third report using evidence from the Portal. The Portal now includes data collected onmedicines that received marketing authorisation in their first indication between January 2021and June 2024. The data continue to mature over each iterationof the Portal, allowing us tovalidate results from previous reports,undertake more granular analysisand begin to assesstrends in accessibility of innovative medicines over time. Transparency:There is a commitment to providing more transparency on the root causes ofunavailability and delay, with 100%participation fromEFPIA member companieswith eligibleproducts. As a result, the Portal now contains a total of 94products that were approved betweenJanuary 2021 and June 2024in their first indication(representing just over one-half of all productsapproved by the European Medicines Agency (EMA) in this period).The Portal has significantlyincreased in size over the pasttwo years,demonstratinganongoingwillingness fromtheindustrytohelp to address the barriers tounavailability and delay. Filing, availability and accessibility:As wegainmore data in the Portal, the complexinteraction between filing, availability and accessibilityis becoming more apparent. There is adistinction between products being available (included in the national reimbursement list) andpatients having access to them.We find the following: •Tounderstand if products are accessible to patients,we need to consider filing,availability(inclusion of a centrallyapproved medicine on the public reimbursement listin a country)andwhetherpatientshavethe possibility toaccess products through alternative access schemes (AAS).1On average across European countries, 67% ofproducts have either been filed for P&R(includingfiled andalreadyreimbursed)or madeaccessible to patients through anAAS. •Focusing on the formal price and reimbursement channel,taking an average acrossEuropean countries, 59% of products have already been filed for P&R.Therefore, thePortal shows that in most instances of product unavailability, the products have beenfiled for reimbursement but have not yet been reimbursed. Looking at all products in thisperiod (which are onaverage 25 months post-marketing authorisation(MA)), we find thefollowing: oOf filed products, 55% have been reimbursed o37% are pending a reimbursement decision,and othe remaining 7% have had anegative reimbursement decision or been withdrawnby the manufacturer2 •Given we havecollected data over a number of years, we can observe if delays andunavailability are changing over time.When comparing how rates of filing for P&R andaccessibility have changed over time for the 66 products included in the 2024 Portalreport,3we find that there has been a 5% increaseover the last year. This has beenprimarily driven by an increase in the proportion of products filed for P&R. •Although there are delays in P&R filing for some products across European countries,this is not a key driver of low availability of medicines in all countries. Across productsthat have been successfully reimbursed, 31%of thetotaltime between MAandavailability can be attributed to the time between MA and P&R filing, while 69% isattributable to the time between P&R filing and P&R decisions at the country level. Variation across countries and the role of AAS:The percentage of products that have beenfiled for P&R or made accessible to patients through anAASvaries significantly across Europeanmarkets; the percentage is higher in larger markets than in smaller markets, particularly in CentralEastern Europe.Inseveralsmaller markets,such as Austria, Greece and Cyprus,a highproportion(over20%)ofproductshave been madeaccessiblethrough AAS. Root causes:The Portal also provides granular data on the reasons why products have not yetbeen filed for P&R across different countries. As set out in the CRA root causes analysis,evidence from the Portalcontinues tosupport that delays in both P&R filing and P&R dec