The EU’s Health Technology Assessment Regulation (EU-HTAR) aims to introduce more harmonised, efficient and evidencebased assessments of new health technologies. However, with companies needing to generate evidence that meets the requirements of both Joint Clinical Assessments (JCAs) and national Health Technology Assessment (HTA) bodies, agile predictive analytics are crucial for success, especially regarding indirect comparisons and PICO simulations.
In this article, we explore the impact of EU-HTAR so far, the challenges of implementation and how advanced analytics can help health technology developers (HTDs) demonstrate value. We also explore what is on the horizon ahead of the rollout of EU-HTAR to orphan medicines in 2028 – and how the industry can prepare.
What is EU-HTAR?
EU-HTAR came into effect in January 2025. The aim was to reduce the burden of multiple submissions, remove barriers to innovation and accelerate access to the market across EU member states (MS). It marked the first permanent partnership between the European Medicines Agency (EMA) and national HTA bodies for joint evaluation. At the heart of this potentially transformative shift was JCAs. JCAs are a single assessment of the clinical effectiveness and added value of new health technologies conducted at an EU level, replacing the need for separate HTAs in each MS.
Initially, JCAs applied to eligible medicinal products with new active substances indicated for cancer treatment or medicinal products which are regulated as advanced therapy medicinal products (ATMPs). On 17 October 2025 the EC established the rules for JCAs of medical devices and in vitro diagnostic medical devices. In January 2028 JCAs will start for eligible orphan medicinal products. In January 2030 JCAs will begin for all remaining categories of eligible medicinal products.
In its 2025 Annual Work Programme, the HTA Coordination Group (HTACG) estimated it would initiate 25 JCAs in 2025 – 17 for cancer treatments and eight for ATMPs.1 In April 2025 the first JCAs for melanoma and paediatric low-grade glioma (LGG) treatments were announced. There are currently 13 ongoing JCAs. At the time of writing, no JCAs have been completed. One has been discontinued due to withdrawal of the marketing authorisation application by the developer. This suggests the work programme was behind schedule in 2025.
Challenges in EU-HTAR Implementation for Developers
The hope is that JCAs will ultimately provide greater clarity, consistency and predictability concerning clinical evidence requirements for HTDs. Of course, this change comes with potential challenges which need to be addressed if the transformative potential of this regulation is to be unlocked.
The first is that EU-HTAR requires planning to start much earlier in the drug development cycle. Developers must also now build evidence packages that meet the needs of both JCAs and MS decision-making – often including the accommodation of languagespecific requirements – in a compressed timeframe. Once a letter of intent is submitted at the point of EMA submission for regulatory approval a PICO scoping exercise by the EU consortium, which is likely to include contributions from each country, finalises the scope of the JCA. Developers then have just 100 days to complete dossier preparation and submission once the finalised scope is available. This creates new challenges for HTDs and Integrated Evidence Planning (IEP) for sponsors and requires proactive planning, clear documentation and the ability to quickly adapt to evolving requests.
Concerns have also been raised about the availability of Joint Scientific Consultations (JSCs). JSCs are designed to offer recommendations to HTDs on their development plans for a medicinal product or medical device, ensuring evidence and methodologies meet all requirements ahead of a JCA. However, there is a striking gap between the number of JSCs compared to JCAs and a misalignment between the number of JSCs and the realities of product development.
