英文【EFPIA】小型市场不可用和延迟的根本原因——国家分析

European Access Hurdles Portal & the Root Causes AnalysisSmaller marketsRevised Country AnalysisMay 20252DRAFT for internal use onlyApproach: We have followed a multi-step approach to understand the root causes of unavailability and delay in smaller marketsDefining the questionLiterature reviewCompany interviewsSolutions and reportingCountry focus groups•Establish what the expected challenges will be with the Portal 2025 data•Draft hypotheses on how the data can be better explained, particularly for smaller markets•Conduct review of existing evidence in the public domain:oAcademic publicationsoGrey literature (policy papers, industry publications, media, etc)• Collaborate with national trade associations to host focus groups and understand local access challenges and policy priorities•Conduct 1:1 interviews between CRA team and company representatives•Pressure-test how the identified challenges have impact on filing and access•Develop proposed policy solutions for overcoming the identified challenges•Draft report on root causes in smaller markets•Publish in April / MayMalta Cyprus Latvia Lithuania Estonia Slovenia Croatia N. Macedonia Montenegro3DRAFT for internal use onlyApproach: We have applied this framework to understand patterns of filing and availability in each smaller market 4…because it is unsustainable (the business case cannot be made) for the MAH to do soExamples:• Unsustainable pricing rules• Unpredictable budget allocation decisions and use of clawbacks3…because features of the local system make it impractical to fileExamples:• Non-transparent P&R criteria and methodologies• Low likelihood of success• Under-resourced HTAbs• Waiting lists for reimbursement 2Examples:• Requirements for price or assessments in other markets• Expectations of price or assessments in other markets• Lack of necessary local data or expertise (low patient population)…because local requirements make it difficult or impossible for the MAH to file1…because it is unnecessary to file to obtain accessExamples:• Direct to tendering• Class-level service lists• Alternative access schemes that provide faster patient accessWhy might there be delays in filing of a newly centrally approved medicine?HypothesesIf MAHs lack a local presence in a smaller market, this can make it impossible, impractical or unsustainable for them to file a new medicine for P&R, depending on the local context and P&R requirements4DRAFT for internal use onlySummary results: We find that the reasons for delays in filing in smaller markets are multi-faceted and driven by the local contextRelative importance of each factor in:…because it is unnecessary to file to obtain access…because local requirements make it difficult or impossible for the MAH to file…because features of the local system make it impractical to file…because it is unsustainable (the business case cannot be made) for the MAH to do soMaltaCyprusLatviaLithuaniaEstoniaSloveniaCroatia N. MacedoniaMontenegroWhy are there delays in fili