A roundtable discussion hosted by PharmaLex and The Life Science Cluster in Norway on 14 May 2025, brought together pharmaceutical companies and industry experts to discuss the implications of the European Union’s Joint Clinical Assessment (JCA) process under the Health Technology Assessment Regulation (HTAR). Representatives from Cencora PharmaLex, the European Confederation of Pharmaceutical Entrepeneurs (EUCOPE), Lundbeck, AstraZeneca, AbbVie, and GSK attended the session, which focused on how the JCA will impact Norway’s national health technology assessment (HTA) and reimbursement timelines, as well as opportunities and challenges related to the new framework.
How will the JCA shape Norway’s national HTA and reimbursement processes?
Herbert Altmann, Vice President of Market access and Healthcare consulting for Europe at PharmaLex and Matias Olsen, Senior Manager of Public affairs and Policy at EUCOPE, provided an overview of the JCA’s goals and mechanisms. The JCA is designed to streamline clinical assessments across Europe by eliminating duplicative evaluations in multiple countries, while still allowing each member state to retain control over pricing and reimbursement decisions.
The first two JCA projects are currently underway, covering an oncology drug and an advanced therapy medicinal product (ATMP). Assessors and co-assessors from Ireland, Germany, France, and Poland are driving these efforts, with the first reports expected by the fourth quarter of 2025. By the end of the year, approximately twenty-five oncology and ATMP submissions to the European Medicines Agency (EMA) will initiate JCA procedures.
However, participants voiced concerns about potential delays in Norway’s reimbursement timelines. A major question was whether national HTA bodies would wait for final JCA reports or leverage draft versions to maintain existing timelines. These uncertainties highlight the need for careful planning and alignment between local processes and the new EU framework.
Addressing challenges with PICO alignment and local relevance
Discussions also focused on the importance of aligning PICO (Population, Intervention, Comparator, Outcome) definitions with national healthcare needs. Smaller countries, including Norway, often have unique comparator requirements different from those of larger nations. Participants expressed concerns that these specific needs might be overlooked during the PICO consolidation process at the EU level, leaving health technology developers (HTDs) unprepared for local requirements. This could result in delays or, in some cases, prevent product launches entirely.
To avoid such outcomes, early engagement with national health authorities will be critical. Participants highlighted the importance of ensuring that local PICO requirements are integrated into the JCA process to keep assessments relevant and aligned with Norway’s healthcare system.
Integrating EU frameworks with Norway’s Nye Metoder
Norway’s HTA framework, Nye Metoder, is tasked with incorporating the EU’s JCA process while preserving autonomous decision-making. Altmann noted that Norway has already taken steps to align its processes with the new framework. For example, a national working group has been established, and the Norwegian Medicines Agency (NOMA) has been actively involved in developing JCA methodological guidelines.
Participants emphasized that the successful integration of the JCA into Nye Metoder will require a seamless transition from EU-level assessments to Norway’s national processes. Maintaining local relevance and ensuring that the JCA does not disrupt existing timelines will be key factors in achieving this.
Further opportunities for collaboration and engagement
The roundtable discussion also explored the potential for Nordic collaboration under the HTAR framework. Countries in the region have a strong history of working together in healthcare, and participants noted that shared methodologies, pooled resources, and regional cooperation could benefit smaller markets like Norway. By working together, Nordic countries could address common challenges and ensure that local needs are prioritized within the broader EU framework.
Another recurring theme was stakeholder engagement. Participants stressed the need to involve patients and clinicians early in the JCA process to ensure that assessments reflect real-world needs. Transparent communication and active participation from these groups will help build trust and ensure smooth transitions between EU and national assessments.
Additionally, participants discussed the value of feedback mechanisms, such as surveys, to gather input from member states and other stakeholders on their experiences with the JCA framework. Such feedback can help identify areas for improvement and refine the process as it evolves.
Best practices for navigating the JCA process
Participants shared several strategies for success under the new JCA framework:
- Engaging in early scientific consultations: Joint scientific consultations (JSCs) with the EMA and HTA bodies enable HTDs to align their clinical trial designs with both regulatory and HTA requirements.
- Preparing comprehensive dossiers: Submitting well-documented dossiers is essential to ensure smooth JCA evaluations.
- Proactively engaging with health authorities: Maintaining open communication with national health authorities and other stakeholders can help identify and address potential challenges early in the process.
Preparing for success in Norway
While the JCA process marks a significant shift in how clinical assessments are conducted across Europe, its success in Norway will depend on how well it is integrated into the country’s existing HTA framework. Ensuring alignment with local needs, maintaining transparency, and fostering collaboration among stakeholders will be essential to realizing the benefits of the JCA.
The roundtable discussion underscored the importance of ongoing dialogue and cooperation as Norway navigates this transition. By working together, stakeholders can ensure that innovative treatments reach patients efficiently, without compromising the quality or relevance of clinical assessments.
