Prepare for Belgian PICO Requirements under EU HTA
The Joint Clinical Assessment (JCA) under the EU HTA Regulation introduces a new process for defining the evidence requirements for innovative health technologies.
As part of this process, Member States contribute to the development of the PICO framework:
- Population
- Intervention
- Comparator
- Outcomes
The Belgian perspective can significantly influence which comparators and outcomes are ultimately included in the JCA scope. According to RIZIV/INAMI, Belgian PICO proposals are developed by Belgian assessors and may be informed through consultation with clinicians, scientific societies and patient organisations.
Given the strategic importance of comparator and outcome selection, companies should ideally begin assessing the Belgian treatment landscape and potential PICO requirements well before the formal consultation process starts. Early preparation can help identify evidence gaps, validate assumptions regarding Belgian clinical practice and reimbursement expectations, and anticipate potential challenges during the JCA process. By understanding the Belgian context at an early stage, companies can strengthen the relevance of their evidence package and be better prepared for both the European assessment and future national market access discussions.
Belgian PICO simulations
To support this preparation, LIVV conducts Belgian PICO simulations. Through a structured assessment of Belgian clinical practice, treatment guidelines, reimbursement criteria and stakeholder perspectives, we help companies anticipate which populations, comparators and outcomes may be considered relevant in Belgium. This enables companies to identify evidence gaps early, optimize evidence generation plans and strengthen their preparation for Joint Clinical Assessments (JCA).
How do we support PICO scoping for Belgium?
LIVV supports pharmaceutical, biotechnology and medical technology companies by providing insight into the Belgian treatment landscape and helping prepare for Belgian input into the JCA PICO scoping process.
Our support may include:
- Review of current Belgian treatment pathways
- Identification of relevant comparators used in Belgian clinical practice
- Assessment of applicable Belgian guidelines and standards of care
- Review of Belgian reimbursement and market access considerations
- Belgian PICO simulations and scenario analyses
- Identification of potential evidence gaps from a Belgian perspective
- Support in preparing responses during PICO consultation activities
Deliverables
Depending on your needs, LIVV can provide:
- Belgian treatment landscape review
- Belgian comparator assessment
- Belgian PICO simulation exercise
- Belgian PICO scoping report
- Gap analysis of available evidence versus likely Belgian requirements
- Strategic recommendations to strengthen Belgian relevance of your evidence package
Experience
Ovarian Cancer – PICO simulation for Belgium under EU HTA
LIVV supported a pharmaceutical company in preparing for the Belgian PICO scoping process for an innovative oncology therapy in ovarian cancer.
Our work included:
- Review of the Belgian treatment landscape and standards of care
- Assessment of relevant clinical guidelines and treatment pathways
- Identification of Belgian comparator(s) and treatment sequences
- Analysis of Belgian reimbursement and market access considerations
- Identification of potential evidence gaps from a Belgian perspective
- Simulation of PICO for Belgium
- Development of strategic recommendations to support participation in the PICO consultation process
The project enabled the client to better understand Belgian clinical practice and anticipate potential challenges related to comparator selection and evidence requirements within the EU Joint Clinical Assessment framework.
About our team
Our PICO simulation and scoping projects are supported by a multidisciplinary team with expertise in market access, health technology assessment (HTA), health economics, clinical research and evidence generation.
The LIVV team combines extensive experience in the Belgian healthcare system with a strong understanding of reimbursement requirements, treatment pathways and stakeholder expectations across a broad range of therapeutic areas.
Depending on the project needs, our team can bring together expertise in:
- Belgian market access and reimbursement
- Health technology assessment (HTA)
- Health economics and outcomes research (HEOR)
- Clinical development and evidence generation
- Literature reviews and treatment landscape assessments
- Stakeholder mapping and engagement
- Oncology, rare diseases, cardiology and other specialized therapeutic areas
Our multidisciplinary approach enables us to assess PICO requirements from multiple perspectives and provide practical, evidence-based recommendations tailored to the Belgian context.
