Series: News from the EU HTA workshop

🔧 PART 6: Key Assumptions Memo

 

📋🛠️ Preparation for EU HTA starts long before clinical data and actual label is known or an MAA is submitted. But you need information on clinical data, label and timelines to prepare in advance.

❓️ So how to plan for these unknowns?

 

📝 Make your key assumptions explicit in a Key Assumptions Memo. This memo should state key assumptions you have made and which are based on information from other parts of your organization. Take it as a start of your internal cross-functional collaboration.

 

Key assumptions should be:

🔹 Planned label (exact wording as per section 4.1 or the SmPC)

🔹 Assumed results from your pivotal trial(s), with focus on magnitude and statistical relevance of effect of study population and relevant subgroups

🔹 Timeline for pivotal trial(s)

🔹 Timeline and pathway for regulatory submission

🔹 Launch countries and launch timeline

 

💡 Gaining detailed insights from other departments can be challenging – especially during ongoing pivotal trials, where information is sensitive. But you need this information and it is better to have this aligned with those who knows best. Take it as a challenge – and a test of organizational preparedness.

 

🤝 And don't worry! Not all assumptions will hold true. But making them explicit will help everyone in your organization being aware of the need to share any update which could impact these assumptions.