❗Fallacy 10 ❓

Clinical expert input has little influence on the JCA scope. Really?

The role of patients, caregivers and clinical experts in the JCA process may appear limited so far. The tarlatamab JCA by Amgen, however, provides an interesting example of how clinical input can contribute to changes in the final assessment scope. 👥

 

In the initial scope, 10 PICOs were proposed, including EpiCO (cyclophosphamide, epirubicin and vincristine) as a comparator and several treatment options for platinum-sensitive patients. Clinical experts challenged the relevance of some of these comparators and highlighted differences between the proposed definitions and actual clinical decision-making.

In the final assessment scope, 7 PICOs remained. EpiCO was no longer included, and the comparator structure was refined based on the distinction between patients suitable and not suitable for platinum retreatment.

 

The JCA report confirms that clinical expert input was considered before the assessment scope was finalised. 💡

 

📌 Key takeaway:

🔹 Understanding actual treatment practice and clinical decision-making is essential for JCA strategy.
🔹 Close and continuous exchange with KOLs can help identify where the proposed PICO may not reflect clinical reality. At the same time, EU HTA requirements regarding expert eligibility and prior interactions with the sponsor should be considered when planning clinical expert engagement.
🔹 Professional societies also have an important role to play in building awareness of EU HTA and ensuring that relevant clinical perspectives are represented.

 

The tarlatamab case is a good reminder: clinical expert engagement should not be seen as a box-ticking exercise. It can matter for how the assessment is ultimately structured. ⏰

 

Have you seen other examples where clinical expert input influenced the JCA scope?