Article

Insights from ISPOR 2024: The evolving landscape of PICO assessments in the EU

At ISPOR 2024, Cencora presented key research on Health Technology Assessment (HTA). Kim Joline Schmidt discusses a poster on Joint Clinical Assessment (JCA) scoping requirements in oncology, revealing how expanding the analysis to 16 countries increased relevant PICOs. Surprising findings included that requirements from 5 countries are driving the high number of consolidated PICOs. Cencora will continue to monitor the scoping process as new guidelines emerge.

5 questions with Kim Joline Schmidt

At ISPOR 2024, Cencora team members presented research posters on a variety of topics in the health economics and outcomes research space. We took the opportunity to chat with them about their work and its potential impact. Here, Kim Joline Schmidt, MSc, Assistant Director, Global Market Access Strategy at Cencora answers questions about the poster, “Understanding Joint Clinical Assessment scoping requirements in oncology: Results of a rapid PICO prediction exercise via an in-house expert network.” Mareike Konstanski, MSc, Anne-Kathrin Sauer, PhD, Patrick Blank, PhD, Annabelle Forsmark, PhD, Bénédicte Morel, PhD, Eduarda Silva, MSc, Elodie Xemaire, PharmD, Herbert Altmann, PhD, Jessica Schepis Martinez, MSc, Julián Sánchez Martín, MSc, Karlien Van den Eynde, MSc, María Arregui, PhD, Patrizia Berto, PhD, Romana Rupčič, Mag. Pharm., David Ringger, and Ruairi O’Donnell, PhD served as co-authors.

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What inspired this research?

Starting in January 2025, all cancer medicines and advanced therapy medicinal products (ATMPs) with new active substances, for which an application for marketing authorization is submitted to the European Medicines Agency, will undergo a Joint Clinical Assessment (JCA) involving all 27 European Union (EU) Member States.

The scoping process is a fundamental part of the JCA, defining the PICO (population, intervention, comparator, outcome) requirements to be addressed by Health Technology Developers (HTDs) in the HTD submission dossier.

This research was inspired by internal engagements in the EU-HTA task forces and the industry's need to better understand the scoping process within the framework of the JCA. We also sought to identify associated risks and opportunities of PICO simulations.

Was there a hypothesis that was confirmed through the research?

Yes, we hypothesized that—compared to the EUnetHTA 21 analysis for Pluvicto—including eight additional countries and the most recently launched comparators up until May 2024 would result in an increased number of relevant PICOs to be addressed in the JCA dossier by HTDs. This was confirmed by our findings. With 16 countries covered instead of 8, our analysis identified 12 relevant comparators and 18 consolidated PICOs, as opposed to the 6 comparators and 6 PICOs found in the EUnetHTA 21 analysis.

Was there anything in the research that was surprising, that you didn't expect, that you found out?

An interesting yet expected finding was the varying time frames for innovative product launches across the assessed countries. In some countries, the most recently authorized medicinal products were not yet available, which likely contributed to the high number of comparators and thus consolidated PICOs in our analysis.

Additionally, we discovered that the high number of PICOs was primarily driven by 5 countries—Germany, Ireland, Italy, Portugal, and Spain—which required comparisons against all relevant comparators. According to the EUnetHTA 21 scoping guideline, each requested comparator leads to a single PICO in the consolidation process.

What are the next steps from this research?

We will continue to monitor developments regarding the scoping process closely. While PICO simulations allow HTDs to gain insights into country-specific responses, the PICO scope defined within the JCA framework will not assign countries to specific PICOs, nor will it reveal the number of countries to which the PICO requirements apply.

A crucial methodological guideline by the Health Technology Assessment Coordination Group (HTACG) is still pending, and it remains to be seen if there will be any significant changes to the EUnetHTA 21 guideline that underpinned our analysis.