The new European Union (EU) Health Technology Assessment (HTA) Regulation introduces the Joint Clinical Assessment (JCA), aiming to harmonize evaluations of new therapies across EU member states. This centralized approach presents opportunities for streamlined market access but also poses challenges due to national healthcare differences. However, despite the benefits of JCA, significant challenges may arise due to the variability in national healthcare systems, potentially leading to delays in market access and reimbursement decisions.

With the JCA now in effect, we spoke with Andrea Mantovani, Alira Health Partner, Market Access and Pricing, about its impact on pharmaceutical companies hoping to bring new therapies to market.

How is the JCA reshaping market access strategies for pharmaceutical companies in the EU?

In the past, companies tackled each national HTA process separately, adapting value evidence packages to meet diverse local requirements. Now, they face a more unified, yet challenging, landscape, one that demands a centralized evidence generation strategy aligned with a common set of criteria across the EU.

One of the most significant changes is the need for early engagement with European HTA bodies. Companies now need to collaborate with HTA stakeholders much earlier in the development cycle to ensure their clinical trial designs, endpoints, comparators, and patient populations align with JCA expectations. These early interactions are crucial for identifying potential evidence gaps and making timely adjustments to trial protocols, helping to avoid costly delays and unmet requirements down the road.

Strategic evidence planning has also taken center stage. Unlike before, where value dossiers were tailored post-EMA approval for each country, companies now need to plan their evidence generation far in advance. A well-thought-out evidence strategy ensures smoother access across multiple markets while addressing the unique needs of individual member states.

Furthermore, pharmaceutical companies are now expected to go beyond the traditional regulatory focus on safety and efficacy. They must generate data that demonstrates the relative clinical effectiveness of their treatments compared to current standards of care across different healthcare systems. This involves choosing widely accepted comparators, designing trials that reflect real-world patient populations, and incorporating meaningful patient-reported outcomes (PROs) and quality-of-life metrics—critical factors for health authorities focused on long-term value and cost-effectiveness.

Finally, companies should now focus on significant organizational realignment. It’s vital to ensure all internal teams—from clinical development to market access—coordinate their approach.

Do you see global pharmaceutical companies and smaller firms, such as biotechs, adopting different strategies to meet JCA requirements?

Large pharmaceutical companies leverage extensive resources, key stakeholders’ relationships, and wide and deep market access and Health Economics and Outcomes Research expertise.

Their key strategies include:

• Parallel evidence generation addressing JCA and national needs.
• Comprehensive health economic data, PROs and real-world evidence.
• Streamlined processes through global market access blueprints.
• “Glocal” cross-functional teams ensuring coordination across JCA reviews and national market access and reimbursement.

Despite these advantages, large firms should stay agile to address discrepancies between JCA outcomes and national reimbursement requirements.

In our experience, biotechs often lack internal EU market access expertise, making it crucial to establish strategic partnerships early to manage evidence submission effectively. Therefore, they adopt a more focused approach:

• Prioritize high-impact indications and orphan drug opportunities.
• Outsource evidence generation and HTA submissions to specialized firms.
• Build flexibility into trial designs to adapt to JCA requirements.
• Partner with larger firms or consultancies to navigate complexities.

With limited resources, biotechs must carefully balance short-term regulatory goals with long-term market access strategies to ensure sustainability.

With some early JCA pilots already underway, what lessons have emerged that could inform future approaches?

Early pilot experiences from the EUneHTA21 Pilot provided valuable insights, underscoring critical challenges and opportunities that companies must address to optimize their market access strategies under the new framework.

I believe that key lessons from the early pilots highlight the critical importance of early engagement and strategic evidence planning from the clinical trial design phase is essential to prevent misalignment and reduce the risk of rework later. Also, companies must combine global and local approach —leveraging a centralized evidence package while maintaining the flexibility to address local HTA demands effectively. In markets like Germany, Italy, Spain, and France to name a few, local HTA bodies might still require additional real-world data beyond JCA evaluations, making national adaptation critical.

Another important lesson is that a proactive engagement strategy with both European and national stakeholders throughout the development and assessment process is key to avoid last-minute challenges and ensure a favorable outcome.

Ultimately, a strategic, proactive, and flexible approach to evidence generation and stakeholder engagement will enable companies to navigate these challenges effectively and ensure timely access to patients across the EU.

How can Alira Health help its clients to ensure a seamless transition into the JCA era?

Our team provides comprehensive support, from strategic planning to post-submission negotiation, helping clients achieve faster market entry and sustained access.

We help companies transition seamlessly to the JCA framework, reducing risks and accelerating market access. Our expertise includes creating the right cross-functional organization, JCA roadmaps, aligning trial designs and simulating multiple PICOs, generating real-world evidence and PROs, and developing flexible pricing frameworks adapted to national contexts.

Through Health Economics and Outcomes Research support, we deliver economic modeling, patient-reported outcomes, and cost-effectiveness analyses while leveraging AI-driven tools to track trends and identify potential hurdles as well as synthetize critical evidence. We can also facilitate stakeholder engagement by fostering constructive dialogues with HTA bodies and payers, ensuring alignment throughout the process. From compliant JCA dossier submissions to post-assessment negotiation guidance, we provide strategic and operational support that enables a smoother path to market access success.

At Alira Health, we don’t just help companies navigate the Regulation on Health Technology Assessment — we partner with them to optimize their strategies and maximize their market potential.