PCN253 - Oncology Products in the Amnog Process – Learnings for a Successful Dossier Submission

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Since AMNOG reform has taken effect 3.5 years ago, 78 dossiers have been evaluated by the G-BA. Especially with oncology agents, 28 products have started the process and G-BA has finalized decisions for 25 dossiers. In 20 cases additional benefit was granted. Therefore, the success rate of oncology products is 80% and much higher than the success rate of non-oncology products (29%). An analysis of all oncology assessments will reveal key drivers responsible for the positive assessments by IQWiG and G-BA. Beside the study design (H2H vs. indirect comparison), and comparator choice the analysis will focus on submitted endpoints. It will be evaluated which endpoints contribute most in oncology indications to additional benefit. Additional benefit is assessed based on patient relevant endpoints (mortality, morbidity, quality of life & safety). More than 55% of submitted endpoints fall in the safety category, followed by morbidity (approx. 30%), mortality (approx. 10%) and quality of life (approx. 5%). The most important endpoint is mortality (OS), where the G-BA granted additional benefit in 18 out of 20 dossiers primarily based on OS data. In terms of morbidity, PFS, ORR and “Time to Pain Progression” are the top three most submitted morbidity endpoints; however, only “Time to Pain Progression” led to additional benefit in 2 out of 3 cases. Only in one case quality of life contributed to the overall additional benefit decision. OS will continue to be the most additional benefit contributing endpoint in oncology. In the absence of OS, PFS will not help in the overall additional benefit decision by G-BA, unless the MNF can justify PSF to be patient relevant according to IQWiG methodology. Although QoL is an accepted endpoint by G-BA, due to the high methodological standards set by G-BA and IQWiG, manufacturers should de-prioritize this endpoint.