Author: Jo Wallis 

The 2025 World Evidence, Pricing and Access (EPA) Congress in Amsterdam brought together over 1,500 attendees from the pharmaceutical, biotech, and payer/Health Technology Assessment (HTA) sectors. This year’s congress offered critical insights, dynamic discussions, and promising pathways for the future.  

Artificial intelligence remains a key theme, highlighting opportunities for innovative digital and data-driven solutions within the industry. There was a strong consensus that stakeholder collaboration is crucial, especially amidst the backdrop of evolving regulations such as the EU HTA. Additionally, the conference placed significant emphasis on rare disease treatments and orphan medicines, highlighting the unique challenges and opportunities in this critical area. 

The Kintiga team was out in full force, unveiling our brand, showcasing our expanded service offerings, and engaging with peers and stakeholders. In this blog, we share our key takeaways from the conference. 

Key Takeaways from the 2025 Conference 

The Growing Role of AI and Real-World Evidence 

One of the most striking themes of the conference was the increasing reliance on artificial intelligence (AI) and real-world evidence (RWE) in healthcare decision-making. Experts highlighted how AI-powered evidence generation is shaping market access strategies, improving health technology assessments (HTAs), and streamlining reimbursement models. These discussions underscored the urgency of adopting innovative digital solutions to enhance data-driven decision-making across the industry. 

Market Access and Pricing in a Changing Global Landscape – EU JCA  

Pricing and reimbursement challenges were at the forefront of the discussions, particularly in light of emerging regulations, cost containment measures, and the shift towards value-based healthcare models. The congress showcased case studies of successful global pricing strategies and examined the implications of joint clinical assessments (JCAs) in Europe. A key reflection was the need for increased collaboration between industry stakeholders and policymakers to ensure sustainable pricing models that balance innovation with affordability. 

Early Access Programmes and Rare Disease Therapies 

The conference highlighted the expanding role of early access programmes and their potential to accelerate patient access to life-saving therapies. Special attention was given to orphan drugs and innovative reimbursement strategies for rare disease treatments. Experts explored how innovative pricing models could support the financial sustainability of rare disease therapies while ensuring patient access. 

1. Enabling Earlier Access for Rare Diseases 

• On average, 35% of orphan medicines are accessible to patients in Europe. 

• 58% of orphan medicines are available without restrictions. 

• Disparities exist across the EU in access to orphan drugs. 

• Rare diseases are difficult to diagnose, and >90% do not have an approved treatment option. 

• 50% of rare disease diagnoses occur in children. 

2. Why Pricing and Reimbursement for Orphan Medicine is Complex 

• Uncertainty in data due to small patient populations. 

• High costs for a small number of patients. 

• The burden of disease and unmet need is not fully understood, and diagnostic and treatment pathways are not well defined 
• Often does not meet traditional HTA requirements, due to cost-effectiveness criteria, limited patient population-based evidence and country-variable and lack of pragmatic HTA flexibilities to name a few. 

3. How to Enable Faster Access 

• Partnership across the system is vital—early engagement between manufacturers, healthcare systems, and the patient community is key. 

• Earlier consideration of innovative commercial frameworks . 

• Early access frameworks can provide medicines to patients with life threatening conditions, gain clinical experience, collect safety and efficacy data, and confirm unmet need.  

The Impact of EU HTA Implementation 

 The discussions surrounding the EU Health Technology Assessment (HTA) regulations emphasised both challenges and opportunities for manufacturers and regulatory bodies.  

Health Equity and Digital Transformation 

Health equity emerged as a central theme, with speakers addressing disparities in healthcare access and the role of digital transformation in closing the gaps. AI-powered pricing negotiations, patient-centric data collection, and the use of generative AI for market access modelling were explored as tools for driving efficiency and inclusivity in healthcare decision-making. 

EU Market Access Trends and Digital Launch Toolkit 

Another insightful session on pre-launch success shone a light on some key trends in the EU Market Access landscape and outlined some solutions. 

Key trends 

• The cost to bring a product to market is growing. 

• One-third of launches fail in the first year. 

• Significant price declines occur in year two when a product is launched early but with insufficient supporting evidence. 

• Adoption in the first year is often slow. 

• If companies waited to launch with stronger evidence, both price and adoption would be higher. 

Key Insight: As launch complexity grows, pre-launch strategies matter more than ever. Industry pipeline is shifting towards more platform-based technologies, and spending across the EU4+UK is decreasing. 

What Can we do? 

• Engage and collaborate with a larger stakeholder group. 

• Address the “Mind the Gap” issue between R&D and commercial teams. 

• Market access has not traditionally used structured business processes, but adopting these approaches can improve decision-making and efficiencies   

Looking Ahead: The Future of Market Access and Pricing 

Reflecting on the insights shared at the 2025 World EPA Congress, it is evident that the healthcare industry is at a pivotal moment. The integration of AI, real-world evidence, and value-based pricing models will continue to shape market access strategies. 

A key takeaway from this year’s congress is the importance of adaptability. Companies that leverage data-driven insights, embrace digital transformation, and engage in proactive policy discussions will be best positioned for success in the evolving healthcare ecosystem. 

If you would like to discuss any of the above insights in more detail, or find out how Kintiga can support you with pre-launch strategy or AI enabled HTA submissions across Europe, please get in touch via enquiries@kintiga.com