What Happens in the Scoping of a JCA?
The starting point for a JCA is defining the research questions that the assessment will be based on.
It is important to remember that the starting point, i.e. scoping of a JCA, happens before a marketing authorisation is granted via the EMA and European Commission. Therefore, the timelines of the JCA, as shown in the following figure, and their impact on the work of a Member State are of considerable importance.
Figure 5: Timelines of Regulatory Marketing Authorisation (MAA) and JCA process. Adapted from: HTA requirements in relation to the EU Regulation. A German perspective. Webinar 05 May 2023, Dr. Stephanie Said
In Article 8 (6) of the regulation says:
‘The designated subgroup shall initiate a scoping process in which it identifies the relevant parameters for the assessment scope. The assessment scope shall be inclusive and reflect Member States’ needs in terms of parameters and of the information, data, analysis and other evidence to be submitted by the health technology developer. The assessment scope shall include all relevant parameters for the assessment in terms of:’’
- Population: the Patients or population(s) in which the intervention under assessment should be used
- Intervention: The therapeutic diagnostic or preventative intervention under assessment (including setting)
- Comparator: the alternative intervention(s under assessment should be compared
- Outcome: The outcomes of interest (if relevant include minimum follow-up time)
These types of questions are commonly referred to as PICO(s) questions.
Defining the research questions is an important step for the JCA. At this stage, patients can capture patient relevant issues as well as variations across countries. Patients who contribute to the JCA scoping can offer advice on comparators that could be considered and outcomes and share their national needs.
The Joint Clinical Assessment will try to include as many perspectives and cover as many PICO questions as possible.