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Insights from Pharma 2025: Bridging gaps: How to thrive in the new EU HTA landscape
At the Pharma 2025 conference in Barcelona, global industry leaders, innovators, and changemakers gathered to explore the evolving landscape of pharmaceuticals and healthcare. Through a series of in-depth interviews with experts from across the sector, Cencora uncovered valuable perspectives on the challenges and opportunities shaping the future. These include accelerating access to innovation, enhancing patient-centricity, and harnessing the power of data and digital transformation.
These conversations reflect the pulse of an industry in motion, that is committed to driving smarter, more sustainable healthcare solutions in an increasingly complex world. Whether focusing on regulatory evolution, market access, technological breakthroughs, or cross-sector collaboration, each expert offered a unique perspective on how pharma is adapting to meet the needs of tomorrow.
During an insightful conversation, Herbert Altmann, Vice President of Market Access and Healthcare Consulting Europe at Cencora, and Ruairi O’Donnell, EU HTA Lead at Cencora, discussed the practical implications of the EU Health Technology Assessment (HTA) Regulation, focusing on how pharmaceutical and biotech companies, large and small, can prepare for the new centralized process.
During an insightful conversation, Herbert Altmann, Vice President of Market Access and Healthcare Consulting Europe at Cencora, and Ruairi O’Donnell, EU HTA Lead at Cencora, discussed the practical implications of the EU Health Technology Assessment (HTA) Regulation, focusing on how pharmaceutical and biotech companies, large and small, can prepare for the new centralized process.
Mixed readiness across the industry
As EU HTAR comes into effect, companies across the pharmaceutical landscape are at varying stages of preparedness. While large organizations have been actively adapting their internal structures and processes, many mid-sized and smaller companies are still grappling with what EU HTAR means for them. According to O’Donnell, “It’s a mixed bag… Larger companies have been focusing on it for years now, but smaller and even some mid-sized ones are still coming to it new.”
A particular challenge arises in the area of rare diseases. Due to smaller patient populations and the unique hurdles of evidence generation, companies working in rare diseases often face resource constraints that limit their ability to participate in early joint scientific consultations (JSCs). This can lead to potential conflicts of interest when better-resourced companies dominate these consultations, risking inequities in assessment and access to treatments.
These inconsistencies highlight the need for tailored support, particularly for companies unfamiliar with the joint clinical assessment (JCA) and JSC mechanisms at the core of the new EU HTA framework.
A particular challenge arises in the area of rare diseases. Due to smaller patient populations and the unique hurdles of evidence generation, companies working in rare diseases often face resource constraints that limit their ability to participate in early joint scientific consultations (JSCs). This can lead to potential conflicts of interest when better-resourced companies dominate these consultations, risking inequities in assessment and access to treatments.
These inconsistencies highlight the need for tailored support, particularly for companies unfamiliar with the joint clinical assessment (JCA) and JSC mechanisms at the core of the new EU HTA framework.
A Center of Excellence to navigate complexity
To help address these needs, Cencora has established a Center of Excellence for EU HTAR, led by O’Donnell. This center brings together cross-functional expertise to support clients through education, strategy development, and process implementation. “We started with a task force more than two years ago, and formalized the Center of Excellence a year ago,” said O’Donnell. “It concentrates all domain experts–people who can dive into the details, stay ahead of the curve, and advise clients on every part of the process.”
What makes Cencora’s offering stand out is its end-to-end capability, from early strategic advice and clinical trial alignment to technical submissions and local market adaptations. As Altmann explained, “We can offer everything, from awareness, education, and change management to deep expertise in JSCs, PICO simulation, statistical analysis, and even country-level integration.”
What makes Cencora’s offering stand out is its end-to-end capability, from early strategic advice and clinical trial alignment to technical submissions and local market adaptations. As Altmann explained, “We can offer everything, from awareness, education, and change management to deep expertise in JSCs, PICO simulation, statistical analysis, and even country-level integration.”
Integrating HTA early in development
One of the strongest takeaways from the discussion was the importance of integrating HTA thinking into product development early on. “The influence of HTA on clinical development is not new, but EU HTAR has significantly amplified that,” noted O’Donnell. Companies are now incorporating PICO landscaping and HTA strategy as early as Phase II to ensure pivotal trials are optimized for the new European evaluation landscape.
This shift requires a change in mindset, treating HTA not as a late-stage hurdle but rather as a core component of market planning. “We’re seeing clients bring in HTA strategy earlier than ever before. It’s becoming part of their foundational go-to-market thinking.”
This shift requires a change in mindset, treating HTA not as a late-stage hurdle but rather as a core component of market planning. “We’re seeing clients bring in HTA strategy earlier than ever before. It’s becoming part of their foundational go-to-market thinking.”
Timelines and the Letter of Intent: The true starting gun
For companies with oncology or ATMP products in their pipelines—the first therapeutic areas subject to EU HTAR—the preparation timeline is critical. O’Donnell recommends initiating serious planning 18 to 24 months before submission to the European Medicines Agency (EMA). This allows enough time for comprehensive strategy, evidence generation, stakeholder engagement, and process setup.
The conversation also underscored a key procedural nuance: the letter of intent. While this formal declaration to the EMA signals the start of the regulatory journey, it also plays a crucial role in notifying HTA bodies across the EU. “It’s the starting gun,” emphasized O’Donnell. “It notifies both the EMA and the HTA coordination group, allowing all stakeholders to align resources and be ready. Missing this step can cause delays and disconnects.”
The conversation also underscored a key procedural nuance: the letter of intent. While this formal declaration to the EMA signals the start of the regulatory journey, it also plays a crucial role in notifying HTA bodies across the EU. “It’s the starting gun,” emphasized O’Donnell. “It notifies both the EMA and the HTA coordination group, allowing all stakeholders to align resources and be ready. Missing this step can cause delays and disconnects.”
Looking ahead: Building a shared learning system
With EU HTAR still in its early stages, both experts stressed the importance of creating a feedback loop between manufacturers, regulators, and HTA bodies. “This is a learning system,” said Altmann. “And it will only succeed if there is open dialogue, shared experiences, and continuous improvement among all parties involved.”
Cencora’s Center of Excellence is positioned not only to support clients through this learning process but also to contribute meaningfully to its evolution.
Cencora’s Center of Excellence is positioned not only to support clients through this learning process but also to contribute meaningfully to its evolution.
Conclusion: Navigating the new normal in EU HTA
As the EU HTA regulation begins its phased rollout, the next few years will be pivotal. Companies that engage early, think strategically, and build the right capabilities will be best positioned to navigate this complex and transformative environment. As highlighted during Pharma 2025, the regulation is not just a procedural change–it represents a paradigm shift in how innovation reaches patients in Europe.
Watch the full conversation
Watch the full conversation between Herbert Altmann and Ruairi O’Donnell to gain deeper insights into how to approach EU HTAR with confidence and to learn how a comprehensive, strategic approach can unlock success in this new regulatory era.
The contents of this piece contain marketing statements and do not include legal advice.
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