OBJECTIVES: In the German HTA process safety data have to be presented, but in the current rules of procedure details for the requirements are not specified. This study gives an overview on the diversity of displayed AEs in Multiple Myeloma.

METHODS: A database containing all assessed AMNOG dossiers published until end of May 2018 was searched for Multiple Myeloma drugs. Relevant dossiers, corresponding G-BA/IQWiG assessments and G-BA decisions on added benefit were used to extract safety information.

RESULTS: Ten relevant dossiers were identified. Common to all dossiers were overall rates of AEs, SAEs and withdrawals due to AEs. Overall rates of AEs leading to death were presented in eight dossiers. This selection was generally well accepted. Regarding the detailed description of AE data varied from AE/SAE by CTC grade (≥3 or 3+4), detailed constitution of AE/SAE by SOC and PT to different thresholds regarding frequencies of occurrence. This is reflected by frequent criticism by G-BA/IQWiG. E.g. for one dossier in the displayed AEs with CTC grade 3+4 IQWiG criticized the lacking report of SAEs with CTC grade 5 and hence referred to AEs with CTC grade ≥3. Additionally, a threshold of 10 % occurrence was criticized by G-BA who referred to 2 % (AE) or 1 % (SAE) in this case. However, in later assessments frequencies of 5 % occurrence were not commented. Furthermore, G-BA was interested in evaluations by PT and SOC.

CONCLUSIONS: Description of overall rates was quite consistent and generally used for the assessment by G-BA. There was diversity, however, in evaluation of individual events by different AE categories among dossiers. In general, G-BA insisted on detailed analyses, although this was not specified in the rules of procedure. An updated version that specifies the requirement to safety analyses is currently under development.