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09 January 2025
With the introduction of Joint Clinical Assessments (JCAs) in 2025 for oncology products and Advanced Therapy Medicinal Products (ATMPs), pharmaceutical companies face a new challenge: the PICO framework.
This structured approach—focused on defining populations (P), interventions (I), comparators (C), and outcomes (O)—is set to be a cornerstone of the JCA process. While the framework aims to standardise assessments across Europe, its implementation poses significant hurdles.
The Challenge of Multiple PICOs
Simulations of the JCA framework suggest that the number of PICOs required for submission can vary from 10 to 30. Each PICO must be individually addressed with comprehensive evidence, meaning companies will need to produce tailored data for each scenario. However, the exact number of PICOs required is only revealed during the scoping process, leaving a narrow window before evidence submission deadlines. This unpredictability creates a significant burden for companies to anticipate, plan for, and address a potentially wide array of PICOs.
Implications for Pharmaceutical Companies
Failing to adequately address the required PICOs could have far-reaching consequences. A weak JCA assessment may hinder access and reimbursement decisions across multiple European markets, delaying product launches and limiting patient access.
Companies must incorporate PICO estimation and evidence generation into early-stage development plans to avoid these risks.
Key implications include:
Resource Allocation:
Companies must allocate significant resources for evidence generation and analysis early in the development process, even before final PICO requirements are clarified.
Strategic Planning:
Predicting PICO demands will require robust forecasting tools and methodologies.
Market Entry Risks:
Poor alignment with JCA requirements could jeopardize market access across Europe, potentially impacting global launch strategies.
Turning Challenges into Opportunities
Despite these challenges, the structured nature of PICOs offers an opportunity for companies to strategically plan their evidence generation and address Health Technology Assessment (HTA) requirements more effectively.
By leveraging advanced tools and methodologies, pharmaceutical companies can gain a competitive edge in the JCA process.
How GPI Can Help
At GPI, we specialise in supporting companies in navigating the complexities of the JCA process. Our comprehensive approach to PICO identification ensures that clients are well-prepared to meet the requirements of the JCA framework.
Our PICO Identification Process Includes:
Current and Future Landscape Analysis:
We analyse the therapeutic and competitive landscapes to identify potential comparators and key outcomes of interest.
HTA Review of Competitors and Comparators:
A deep dive into historical HTA assessments provides insights into payer expectations and common challenges
Payer and KOL Research:
Engaging with payers and key opinion leaders (KOLs) helps refine PICO estimations and ensures alignment with market needs.
TPP Assessment:
Utilising GPI’s proprietary tools, we assess the Target Product Profile (TPP) to predict potential PICO demands.
Gap Analysis and Evidence Generation Planning:
Identifying evidence gaps and recommending strategies to address them ensures robust preparation for JCA submissions.
Conclusion
Preparing for Joint Clinical Assessments requires early and meticulous planning.
By integrating PICO estimation into the development process, companies can mitigate risks, align with payer expectations, and optimise their chances for successful market access.
GPI Consulting’s expertise and advanced tools provide a roadmap to navigate this complex landscape, enabling companies to confidently approach the JCA process.
To PICO or not to PICO? The answer is clear: proactive preparation is the key to unlocking market success in the evolving European regulatory environment.