Planning the PICO and designing the literature reviews for the JCA Evidence synthesis

Applying the lessons learned from EUnetHTA21

The challenge

Our client has an asset anticipated to qualify for JCA. They could not benefit from JSC. Given the short timelines between communication of the PICOs by the JCA working group and the submission (100 days), the PICO sets need to be anticipated to plan the evidence generation.

The solution

We simulated the JCA process through landscape analysis, our client internal resources and our stakeholders’ network. We used our previous experience in PICO planning projects to select the most likely and second most likely PICO sets. Stakeholder consultation was used to optimise and justify the choices. We structured the literature reviews to accommodate selection of PICO sets and updates.

Key results

We derived a manageable number of PICO sets reflecting the reimbursement landscape in the therapeutic area across Europe and addressing the likely policy questions of the member states. The sets have been externally validated. The evidence synthesis is structured in such a way to be updating easily and accommodate requirements from authorities.

Value to the client

Our client is well prepared for the upcoming JCA of their asset. The PICO sets have strong expert justification and evidence generation is structured in a flexible way to accommodate JCA requirements.