Early strategic evidence planning is a key success factor in the EU HTA landscape: Pamela Vo on navigating the JCA era

As the European Union (EU) ushers in a new era of health technology regulation, pharmaceutical companies face both unprecedented challenges and opportunities. At the heart of this transformation is the EU Health Technology Assessment Regulation (HTAR), which came into effect on 12^th January 2025. Central to this regulation is the Joint Clinical Assessment (JCA), a mechanism designed to harmonise clinical evaluations and minimise duplication of work across all 27 EU member states.

Dr Pamela Vo, VP of HEOR and Value & Evidence at EVERSANA, is helping companies chart a successful course through this complex terrain. In a recent conversation with pharmaphorum, she shared her expert insights.

Early strategic planning and cross-functional collaboration

While economic evaluations remain the purview of national bodies, the JCA now mirrors the centralised approach of the European Medicines Agency (EMA) for the clinical assessment. This shift demands a strategic, pan-European mindset from pharmaceutical companies, coordinating across regulatory, clinical, HEOR, and market access teams.

“While health technology assessment (HTA) itself is not a new concept, the JCA introduces a harmonised clinical assessment process at the EU level, similar to the EU-level regulatory approval by the EMA,” Dr Vo noted. “But it does not provide a value judgement or benefit rating, it simply assesses the clinical evidence and its uncertainty.”

Dr Vo emphasised that early planning is no longer optional – it is essential to market access success.

“For market access and reimbursement in Europe, you need to demonstrate that your product is cost-effective or has an additional benefit beyond what's currently available,” she explained. “With the new EU HTA regulation, the importance of evidence-based assessments has been elevated.”

Challenges at the national level

Despite the harmonisation goals of the JCA, Dr Vo acknowledged that national-level integration of JCA findings remains uncertain.

“The big question is how national bodies will incorporate JCA findings into their local reimbursement processes,” she said. “Some countries have modified their processes, but it still remains to be seen how they will use the JCA outcomes and to what extent it will impact access and reimbursement decisions. If JCA is executed as intended, it will streamline the HTA procedure and contribute to faster and wider access to effective innovative products for patients across Europe.”

Although one of the aims of the JCA process was to decrease duplication of work across Member States, she also highlighted that it may initially have the opposite effect - potentially duplicating the work: “Rather than reducing the burden, some believe the JCA adds another layer of complexity. Companies now have to manage both EU-level and national dossiers.”

Advanced therapy medicinal products (ATMPs) and oncology: A test case

The initial focus of the JCA includes oncology and advanced therapy medicinal products (ATMPs), which present unique challenges, and in a co-authored paper with Ray Ghani, ‘Securing Launch Success within the Context of the New EU Health Technology Assessment (HTA) Landscape in Europe’, Dr Vo previously outlined how the JCA aims to streamline pricing and reimbursement decisions for innovative treatments, particularly in oncology and ATMPs.

“These therapies often rely on single-arm trials or are used in rare diseases, making robust randomised trials difficult,” Dr Vo explained. “There are methodological challenges and data availability issues, but it also gives the JCA Coordination Group a chance to test the new regulation.”

Dr Vo highlighted the value of the Joint Scientific Consultation (JSC), also, which offers early advice at the EU level.

“Similar to national early advice services (e.g., NICE), the JSC provides guidance from the HTA perspective, but at the EU-level. In addition, there is opportunity to seek parallel JCA/EMA,” she said. “This is a significant opportunity for companies to align their clinical development with HTA expectations early on.”

Evidence generation and the PICO framework

The JCA process requires evidence generation aligned with the PICO framework – Population, Intervention, Comparator, and Outcomes. Dr Vo stressed the importance of early PICO predictions, systematic literature reviews (SLRs), ITCs, and dossier preparation.

“Companies must predict the most likely PICO scenarios that are relevant to all 27 Member States before the final scope assessment is shared with the HTD,” she explained. “Accurate PICO prediction is critical because the timeline is tight, only 100 days from scope finalisation to dossier submission. That’s why early planning is vital.”

In therapeutic areas like rare diseases, where direct head-to-head active comparator trials are often impractical, indirect treatment comparisons (ITCs) become indispensable. Dr Vo, along with Chris Cameron, explored this in another piece titled, ‘The Integral Role of Global Indirect Treatment Comparison in Europe’s JCA’, stressing that a robust global ITC programme is a linchpin for successful HTA submissions.

“ITCs allow us to compare treatments across different studies, which is crucial when direct comparisons aren’t feasible,” Dr Vo explained. “But it’s not just about doing the analysis, it’s about doing it right, with transparency and methodological rigour.”

She outlined several strategic pillars for building a successful ITC programme, including early planning, stakeholder alignment, methodological consistency, and global applicability.

“The gold standard is a head-to-head comparator trial, but that’s not always feasible,” Dr Vo said. “ITCs allow us to compare treatments indirectly, which is crucial for demonstrating relative effectiveness under the JCA.”

EVERSANA’s end-to-end support

Dr Vo concluded by highlighting EVERSANA’s comprehensive capabilities in supporting JCA submissions. From JSC advice and evidence generation planning to strategy development and dossier writing, the company offers end-to-end support tailored to the new EU HTA framework.

“We’re helping clients not just react to the changes, but proactively prepare for them,” she said. “Success in this new landscape requires agility, expertise, and a deep understanding of both regulatory and payer expectations.”

“We’re currently leading a JCA programme for a major pharmaceutical company, supporting every step – from PICO prediction and literature reviews to ITC analysis and dossier development,” she said. “We’re one of the first companies actively supporting clients through the JCA process [and] our hands-on experience positions us to guide companies through pre-JCA, during JCA, and post-JCA phases.”

Certainly, Dr Vo’s insights underscore the strategic complexity of launching innovative therapies in Europe under the new HTAR. Her emphasis on early planning, evidence-based strategy, and cross-functional collaboration offers a clear roadmap for success; a path on which partners like EVERSANA better equip pharmaceutical companies to navigate the evolving HTA landscape and deliver transformative treatments to patients across Europe.

About the interviewee

With 20+ years of HEOR experience in the pharma industry, Dr Pamela Vo has a demonstrated history of strategically turning ideas into impactful results with a proven track record of 30+ peer-reviewed publications, substantial market access and reimbursement successes, regulatory approvals, and clinical product adoption. She has worked across the full product lifecycle in multiple therapeutic areas in global, local, as well as international settings. Before joining EVERSANA, she served as the executive director of global HEOR and access evidence at Novartis. Some of her prior roles include worldwide HEOR director within the Global Patient Access division at Novartis and other leadership roles at Abbott/AbbVie, where she managed diverse portfolios in healthcare. Dr Vo also served as the ISPOR-Chicago regional chapter president in 2011-2012. Dr Vo holds a Doctor of Pharmacy, a Master of Pharmacoeconomics & Policy, and a Bachelors in Biochemistry. As a post-doctoral USC/AstraZeneca fellow, she completed a 2-year HEOR fellowship with a project thesis in Acute Coronary Syndrome and Ankylosing Spondylitis. Dr Vo is a licensed pharmacist in the state of Illinois and California, US. She is originally from the United States, but has been residing in Switzerland since November 2015.