EUnetHTA Joint Scientific Advice

Our client had secured a valuable slot with EUnetHTA to seek Joint Scientific Advice. However, they had no experience of managing the process and a lack of clarity on the areas they were seeking advice. The client chose Initiate to manage the process for them, tasking us with eliciting key questions from within the company.

Initiate developed a bespoke strategy workshop, following a series of interviews and an assessment of their planned pivotal Phase 3 trial. We developed a list of ‘red line’ areas that we would not seek advice on and highlighted non-negotiable areas in the trial and development process, as well as developing and refining the key questions for the meeting and producing the briefing books. Alongside this, we started to develop an early cost-effectiveness model to test during the advice process.

The project culminated in our attendance of the Joint Scientific Advice meeting alongside the company, during which we led the process of seeking advice.

The client received advice which significantly informed their development programme and caused a shift in focus on key components of the intended indication. Key areas of the access strategy were affected, including the inclusion of a second PRO to ensure sufficient specificity. Our recommendations on the back of the meeting, namely that the label should be refined and additional key data sought, have also been crucial in driving key strategic changes which will ensure the client enters their market earlier.