💡 Lots of PICOs and only one of two PICOs for German AMNOG covered!

Alternative:
Lots of PICOs,  but only one out of two is covered for the German AMNOG!

Durvalumab was approved as monotherapy in FL HCC as a Type II variation with a start date Dec 31st, 2022, and an opinion date Oct 12th, 2023. The label has been approved as submitted by the applicant (imfinzi-h-c-004771-ii-0057-epar-assessment-report-variation_en.pdf).

PICO exercise for Durvalumab monotherapy in FL HCC revealed 13 PICOs:

🔹Of those were 4 for the full population. All 4 PICOs listed identical Outcomes and differed only by the respective Comparator.

🔹Another 4 PICOs set the same Comparator for the subpopulation “Child-Pugh A or no liver cirrhosis”, but differed in efficacy and safety endpoints.

🔹Another 2 PICOs were set for subpopulations eligible / non-eligible to loco-regional therapy, comparing eligible patients with transarterial chemoembolization or transarterial radioembolization.

 

▶️For all PICOs the intervention was defined as “Durvalumab application according to SmPC”.

One Comparator for the whole population is Durvalumab + Tremelimumab, which has been approved on Jan 30th, 2023. EMA for monotherapy started Dec 31st, 2022. Assuming a PICO survey within the first month of the MEA procedure, it remains unclear how Durvalumab + Tremelimumab would have been named, given the lack of approval?

 

Durvalumab has been assessed for this indication by G-BA on Jun 6th, 2024, in two subpopulations:

a.  Child-Pugh A or no liver cirrhosis: comparison vs. Atezolizumab +
Bevacizumab OR Durvalumab + Tremelimumab

b.  Child-Pugh B: comparison vs. Best Supportive Care

Both alternatives of subpopulation a. are covered by PICO 5 and PICO 6.

 

Subpopulation b. is not covered by the PICO exercise:

🔹PICO 9 is the correct subpopulation but has Sorafenib as Comparator.

🔹PICO 13 has Best Supportive Care as Comparator but the population includes Child Pugh B and C with conditions for immunotherapy.  

 

❓️ It is not clear, how this assessment scope could have been used for Germany.

 

📖 More on how to prepare for EU HTA in our book: EU HTA 101 (updated in October 2024) https://lnkd.in/eAsxt7NZ