📢 Lots of PICOs again - 3️⃣ of them just for the G-BA?
 

📅Adagrasib was approved as a monotherapy for advanced NSCLC with KRAS G12C mutation and disease progression after at least one prior systemic therapy. The MAA process was initiated on 19 May 2022, with a marketing authorisation granted on 5 January 2024. The label was approved as submitted by the applicant (https://www.ema.europa.eu/en/documents/assessment-report/krazati-epar-public-assessment-report_en.pdf).
 

The PICO exercise for adagrasib identified 1️⃣3️⃣ PICOs:

-5️⃣ of which were for the whole population, differing only in the comparator. Note that for two PICOs, comparator classes were defined (PICO 2: "Platinum-based doublet chemotherapy"; PICO 4: "Immune checkpoint inhibitor monotherapy"). And: Sotorasib was included as a comparator in PICO 1, although it will not be approved until January 2022.

-8️⃣ PICOs involved subpopulations, most of which had different comparators to the PICOs for the whole population.

-4️⃣ PICOs explicitly required subgroup analysis, stratifying patients by number and/or type of prior lines of therapy. Note that subgroup analysis is already required in the Implementing Acts on JCA, which was published as a draft prior to this PICO exercise.

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🔎For all PICOs, the intervention has been defined as "adagrasib monotherapy" without reference to SmPC. All required outcomes were summarised in an outcomes list.
 

Adagrasib has not yet been evaluated by the G-BA. Therefore, a (direct) comparison of this #PICOExercise with AMNOG is not possible. However, the G-BA published its (re-)assessment of Sotorasib in this indication on 3 August 2023. From this perspective, the definitions of PICO 11, PICO 12 and PICO 13 correspond to the G-BA subpopulations b), a) and c), with the only difference being the comparator for subpopulation c).
 

💭Given the importance of the PICOs to EU HTA, we see that there is much to learn from the PICO Exercises.

Follow our thoughts in this new series Reflections On Second Wave Of PICO Exercises to Get Ready For EU HTA.

 

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