The Challenge
The EU regulatory landscape is evolving, with one of the main changes being the introduction of the Joint Clinical Assessment (JCA). The regulation aims to harmonise clinical assessment for new products across EU Member States. Although it is underway and will start being applicable to products as soon as 2025, much is still unclear about its operationalisation and impact across different markets.
Inbeeo’s client, a global pharmaceutical company, was looking to understand how the JCA is likely to impact drugs’ access pathway in Europe. As the client is trying to break into the orphan space, they had a particular interest in understanding potential opportunities and risks for orphan products.
The Approach
Given that much uncertainty still exists around the JCA – with many of its processes still in the works – gaining insights from experts at the heart of the ongoing negotiations and familiar with the building of the processes, was perceived as key.
Inbeeo leveraged its expert network to identify and recruit payer representatives across key markets in the EU (Germany, France, Italy), as well as one representing EFPIA’s interests and one expert on HTA appraisals for rare diseases.
An in-person advisory board was held from which EU and country-level insights where synthesized and ordered in a roadmap, tailored to the client’s planned tactics. Considering the experts’ insights, Inbeeo provided a set of targeted recommendations for the client.
The Impact
Insights from this advisory board were used for planning purposes in the coming years, as the regulation unfolds. They were also used to revise the clinical development plans for an orphan product in development.
In addition, insights from the meeting shed light on several unanswered questions regarding the value of early scientific advice by different HTA bodies and the relevance of different types of evidence to support HTA dossier submissions.
