HTA Policy Update
Section Editors: Sandra Nestler-Parr, PhD, MPhil, MSc; Ramiro E. Gilardino, MD, MSc
Welcome to the HTA Policy Update, which provides a brief update on notable HTA policy developments from around the globe. We welcome suggestions and guest editorials for future issues. Please contact the Value & Outcomes Spotlight editorial office with your ideas.
Latest Data Demonstrate Significant Disparity Across Countries in Europe in Time to Availability and Total Availability of New Medicines
Guest Editor: Mark Orchard, BSc, Senior Consultant, Cogentia, Cambridge, United Kingdom
As the first few technologies undergo Joint Clinical Assessment (JCA) as part of the European Union Regulation (EU-HTAR; Regulation 2021/2282) on health technology assessment (HTA), there is an aim to harmonize the approach to clinical assessment across EU Member States, with the objective to reduce duplication of effort, and ultimately achieve faster, broader, and more equitable access to medicines.
The latest report from the European Federation of Pharmaceutical Industries and Associations (EFPIA), Patients’ Waiting to Access Innovative Therapies (W.A.I.T.) Indicator, illustrates the importance of this objective, painting a stark picture of the disparity across countries in Europe in time to access and availability of medicines. Based on an analysis of 173 medicines approved by the European Medicines Agency (EMA) between 2020-2023, average time to availability across 36 countries was 578 days in the 2024 analysis, an increase of over a month relative to the 531-day average observed in the 2023 report. There was a greater than 700-day difference between the countries with the fastest and slowest availability: 128 days in Germany and 840 days in Portugal.1
Total availability ranged from 156 of 173 medicines in Germany to 6 of 173 medicines in Türkiye. Of the 36 markets scoped, 20 had a rate of availability below 50%. Even where access in a market is achieved, this is often on a named patient basis only, with access on an individual patient basis accounting for >30% of the available medicines in Austria, Denmark, Greece, Cyprus, Iceland, Lithuania, Serbia, and Bosnia.
Comparing data between the EFPIA W.A.I.T. Indicators for 2022, 2023, and 2024, permits an assessment of trends for specific markets. Total availability of medicines increased year-on-year in Spain, Bulgaria, Portugal, and Slovakia. Meanwhile, total availability decreased year-on-year in France, Denmark, Sweden, Greece, and Hungary. Looking at time to availability, Bosnia, Scotland, and Poland improved each year, while 9 countries, including England, The Netherlands, and France saw increased delays to availability year-on-year.
Notably for data collection for the 2024 W.A.I.T. Indicator, there was some pushback from national payers at the summary data presented by EFPIA. Most prominently, Spain’s health ministry published a separate report that provides an alternative picture to that in the EFPIA report.2 While there is detail provided in the accompanying reports, headlines and discourse around the EFPIA W.A.I.T. Indicator tends to frame time to access around time from central EMA marketing authorization to availability. National payers may reasonably argue that this unfairly biases the data against them, given that they can only begin their national HTA procedure once a dossier has been submitted.
The topic of time from central approval versus time from filing of a pricing and reimbursement submission by marketing authorization holders was explored in the accompanying access hurdles portal report.3 This analysis found that 31% of the total time between marketing authorization and availability can be attributed to time between EU marketing authorization and national pricing and reimbursement filing, with the remaining 69% attributed to national decision making.
Further analysis found that, on average, 59% of products were either reimbursed or filed for reimbursement in individual European countries, with this being as high as 91% in Germany, and as low as 9% in Malta. The most common reason for not filing for national reimbursement was economic viability (37%), followed by value assessment process (28%), health system infrastructure (20%), and pricing and reimbursement process (15%).
As well as data for Europe, a similar W.A.I.T. indicator was recently published for 2025 by FIFARMA,4 analyzing access of all medicines globally approved (defined as the US Food and Drug Administration [FDA] or EMA approval) between 2014-2024 in 10 Latin American countries. Compared to an average of 19 months from marketing authorization to availability in Europe, in Latin America the total time to availability is on average 67 months from FDA or EMA approval, equating to over 5 and a half years of delay. Notably, these 67 months comprised 38 months from EMA or FDA approval to national regulatory approval in Latin American countries, and a further 29 months from national regulatory approval to local availability. Perhaps most notably, of FDA/EMA approved medicines, only 33% are available publicly in at least one of the 10 Latin American countries included in this analysis.
In summary, time from marketing authorization to patient access to novel medicinal products continues to increase in Europe, with products assessed in the 2024 EFPIA W.A.I.T. report taking 47 days longer than observed in 2023, although this does not capture the extent to which delays were due to HTA, price negotiation, or companies not submitting an HTA application. There is a wide disparity in time to availability, with a range of over 700 days between the fastest and slowest countries to achieve access. Furthermore, of the markets assessed in 2024, over half (20 of 36) had a rate of availability below 50%. These data support the need for a more harmonized HTA process across Europe to drive efficiency, breadth, and speed of availability of new medicines. The new JCA procedure may provide a solution, although this is entirely contingent on it delivering against its stated aims, as well as on Member States adapting their local methods to incorporate the JCA report, thereby streamlining assessment.
References
- European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA’s Recommendations for the Future of EU Multiannual Financial Framework. https://efpia.eu/news-events/the-efpia-view/statements-press-releases/efpia-s-recommendations-for-the-future-eu-multiannual-financial-framework/. Accessed July 22, 2025.
- Ministerio de Sanidad. Financiación de medicamentos innovadores en España. https://www.sanidad.gob.es/areas/farmacia/publicaciones/docs/20250503_Informe_financiacion_medicamentos_innovadores.pdf. Published May 5, 2025. Accessed July 19, 2025.
- Charles River Associates. European Access Hurdles Portal: Results From the Third Year of Data Collection. Published May 2025. Accessed July 19, 2025.
- Ballalai A, Courtney O. FIFARMA Patient W.A.I.T. Indicator 2025: Latin America. https://fifarma.org/wp-content/uploads/2025/05/FIFARMA-PATIENT-WAIT-INDICATOR-2025.pdf. Accessed July 19, 2025
