PCN386 GERMAN BENEFIT ASSESSMENT IN THE FIELD OF ONCOLOGY: FACTORS INFLUENCING THE BENEFIT RATING IN ADDITION TO COMPLYING WITH THE APPROPRIATE COMPARATOR

Abstract

For benefit assessment of new pharmaceuticals in Germany, the Federal Joint Committee (FJC) defines appropriate comparators of four categories: one specific drug, a list of drugs, patient individualized therapy, and best supportive care (BSC). The aim of the study was to evaluate factors influencing the outcome of the assessments in oncological indications with a negative benefit rating in addition to complying with the assigned appropriate comparator. Information on appropriate comparators and benefit assessment were retrieved from a databank containing information on all AMNOG dossiers in the field of oncology. Dossiers were analyzed for data on indication, target population, line of therapy, appropriate comparator, and added Benefit. 109 dossiers including 215 separate (sub) labels were identified in the field of oncology between 2011 and 2018. The appropriate comparators assigned by FJC were distributed as follows: 51 (24%) specific drug, 88 (40%) list of drugs, 35 (17%) patient individualized therapy, and 41 (20%) BSC. More than half of these benefit assessments resulted in no added benefit despite compliance with the FJC-assigned comparator in the dossier. Factors leading to a negative benefit rating in these assessments were identified by analyzing the reasons for the FJC decision. Four major reasons for negative benefit ratings can be determined: low quality of evidence, lack of patient relevant study endpoints, discrepancy between label and study population and insufficient study design. The appropriate comparator assigned by FJC significantly influences the outcome of AMNOG benefit assessment. Even if a comparison against the appropriate comparator is performed in the AMNOG dossier, further factors play an important role for a positive outcome of the assessment, comprising the quality of evidence, the patient relevance of study endpoints, the alignment between study and label population as well as and the quality and validity of the study.