Defining the research question(s) for Joint Clinical Assessment

A key aspect of the EU HTA process is the scoping step which will take place prior to the Joint Clinical Assessment (JCA). This includes the definition of the research question for the assessment under possible PICO schemes.

• Patient population (P),

• Intervention (I),

• The comparator (C)

• The study endpoints which determine the outcome (O)

These parameters will form the basis for the clinical evaluation of any medicine or technology under review.

The standard of care alternatives, and the approach to patient management can vary substantially across member states, with divergence in guidelines, approvals, and uptake, all of which may need to be reflected in the core EU HTA dossier.

In the scoping process, the coordination group will first invite member states to submit PICO schemes corresponding to their National setting through distribution of a structured survey. After a ratification and consolidation process, the Health Technology Developer (HTD) is then notified of a number of PICO schemes that need to be addressed in the EU HTA dossier.

In complex indications, such as oncology and rare diseases where the standard of care is not always well defined, this can lead to wide variation in potential PICO schemes and create substantial uncertainty in the evidence required for a successful submission.

Understanding and predicting likely PICO schemes can help to ensure that companies are optimally prepared for the JCA process.