EU HTA regulations, real-world data, and AI were the most discussed topics at this year’s European conference.
The HEOR industry is constantly evolving, from new EU HTA regulations to the impact of AI. Our team attended ISPOR Europe in Barcelona, Spain, where John Cook, our chief scientific officer, shared the compelling topics people were discussing this year.
#1) Companies are sprinting to follow new EU HTA regulations.
The 2025 EU HTA regulations present significant opportunities. They will work to improve the consistency and efficiency of health technology evaluations across member states. Although the economic evaluations and final HTA decisions will remain the responsibility of each member country, information on patient populations, interventions, comparators, outcomes, and study designs (PICOS) will be streamlined into a single evaluation process across all countries.
This new process will help HTA agencies face a variety of challenges, including resource constraints, methodological challenges, evidence requirements, coordination difficulties, and balancing national needs with EU-wide standards.
For manufacturers looking to market in Europe, submitting evidence may take on a new spin, and early preparation is crucial.
“Because of the brief time from when the set of PICOS is determined during the JCA process, the manufacturer has limited time to prepare the required information. As a result, manufacturers should take advantage of the Joint Scientific Consultation process to obtain early advice and prepare for anticipated PICOs well in advance,” says Cook.
“It was said {at ISPOR} that it could take two years to fully understand the impact of the upcoming changes, so paying attention to the submissions and responses early in the game will be vital to long-term success,” adds Cook.
#2) Real-world data is still at the cornerstone of HEOR.
Real-world data was discussed throughout the conference, and it is still an important part of showing a product’s value to payors. Analysts forecast a tripling of RWE efforts by 2032.
“Real-world evidence (RWE) will always remain one of the central ways in which information is gathered to help inform decisions around reimbursement and access.” – John Cook, Chief Scientific Officer – CHEORS powered by BioBridges.
“As you walk around the posters, there’s a lot of information that’s coming from real-world data that is being analyzed to look at the positioning of new products and how existing therapies are doing — their strengths and weaknesses,” says Cook.
He adds, “Real-world evidence (RWE) will always remain one of the central ways in which information is gathered to help inform decisions around reimbursement and access.”
“Companies can use RWE to supplement some of their work in clinical trials,” says Cook. “You may have a one-arm study, and in those situations, the use of RWE as a comparator becomes really critical.”
#3) We’re seeing more examples of AI in action.
In the past year, AI has become mainstream and seems to be the next wave of a major tech shift since the internet onset in the nineties.
“One thing is for certain and was noted in several posters, AI cannot yet answer subjective questions, but it has sped up the gathering of information. The human mind is very much needed to assimilate AI information,” says Cook. “To me, AI will help to pull and synthesize available information in a faster and potentially more comprehensive manner.”
The conference held a short course entitled Introduction to Generative AI for HEOR which provided attendees with an understanding of large language models (LLMs) which are revolutionizing the field of HEOR. Leaders from Bristol Myers Squibb and Estima Scientific taught this course.
Another course, AI-Powered HEOR: Advancing Insights and Decisions with Large Language Models taught participants how to conduct comprehensive and efficient systematic literature reviews, synthesize evidence at scale, and construct robust economic models that support healthcare policy and market strategies.
Conclusion
As we heard from experts at ISPOR Europe 2024, EU HTA regulations are creating uncertainty for companies. The outcomes of these changes will be something we will learn over the next few years as companies adapt to a new way of working.
RWE continues to be central to understanding product value, and analysts forecast a tripling of RWE efforts by 2032.
As we move into 2025, AI is on everyone’s minds and there are more examples of its applications, particularly improving speed and productivity in the HEOR space.
CHEORS powered by BioBridges has experts who can quickly bring you the HEOR data and insights you need to establish the value of your product.
Talk to us.
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