Predicting PICO and Preparing for JCA: Insights from EVERSANA at ISPOR EU

As the EU HTA Regulation moves into implementation, Joint Clinical Assessment (JCA) is reshaping how evidence is planned and delivered across Europe.  

At ISPOR EU in Glasgow, EVERSANA’s Pamela Vo, VP, HEOR, joined a cross‑stakeholder panel featuring: 

• Niklas Hedberg, Chief Pharmacist, Dental and Pharmaceutical Benefits Agency (TLV) and Co‑Chair of the EU HTA Coordination Group 

• Michael Happich, Senior Director, International Value & Access, Eli Lilly and Company

• Zsombor Zrubka, Head of HECON, Obuda University 

Together, they discussed the evolving expectations under the new EU HTA framework and how companies can better anticipate PICO requirements to support faster, more consistent patient access. 

JCA: A Promising but Demanding Shift 

JCA has the potential to streamline clinical assessments and reduce duplication across Member States. But, as the panel acknowledged, early waves will bring operational pressure, new timing challenges and the need for a more collaborative, European‑level mindset. 

Pamela noted that while some sponsors welcome the change, others see JCA as “an additional dossier.” The path forward requires transparency, early preparation and a willingness to adapt. 

PICO Prediction: Why Blended Methods Work Best 

With JCA accelerating evidence needs, predicting PICO accurately is now essential. The panel highlighted three complementary approaches: 

• SLRs for depth 

• Country insights for real‑world relevance 

• AI tools like NAVLIN PICO Planner for speed and breadth 

The consensus was clear: combine methods, don’t choose one. AI can rapidly scan guidelines and prior HTA decisions, while experts validate local nuance. 

Read the full pharmaphorum interview. 

Why Tools Like NAVLIN Matter Now 

As evidence demands grow, AI-enabled platforms such as NAVLIN PICO Planner help teams map expectations earlier, reduce uncertainty and consolidate inputs more efficiently — giving companies a head start in navigating a more harmonized EU landscape. 

Early JCA assessments in oncology and ATMPs will shape how processes evolve. JCA won’t resolve national affordability constraints, but it can make clinical evidence more consistent and appraisals faster. To succeed, teams must invest in blended methods, embrace collaboration and adopt tools that support earlier, more aligned evidence generation. 

Why Eversana’s Value & Evidence Team is the ideal partner of choice for JCA: 

• The JCA evidence requirements are V&E team’s core capabilities (e.g., SLRs, ITCs, Dossier) 

• Real-time experience in supporting many clients through the JCA process 

• Top-notch ITC expertise with globally recognized ITC expert (e.g., Chris Cameron) 

Learn more about EVERSANA’s Value & Evidence. 

 

 

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