Recently published G-BA assessment in CLL with interesting implications

GIPAM tracks regularly published G-BA decisions on potential implications for future HTA/market access strategies. Ibrutinib, in combination with Venetoclax, was a recent assessment (July 2023) that has important strategic implication; it ended with a no-benefit assessment (https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/919/).

G-BA accepted the comparator arm of the presented trial only for one out of two subpopulations, did not accept the “raising-up” approach with a p<0.15 instead of a p<0.05 rule (“Anhebungsregel”) as proposed by the pharmaceutical company, did not accept more recent data cuts that were not pre-planned and not requested by EMA and had different views on PFS as a patient-relevant outcome.

Feel free to contact us for more detailed insights!

Contact