Main studies: DAPA-CKD and DAPA-HF Main drivers of decision: Positive effects of dapagliflozin, compared to the ACT, were shown for indication 1 for the endpoints overall mortality, end-stage kidney disease (ESRD) and hospitalisation for heart failure. The positive effect for the endpoint ESRD was supported by results of the additionally presented endpoint on renal morbidity. For indication 2, there was an added benefit of dapagliflozin for the endpoint hospitalisation due to heart failure. There was no suitable data available for health-related quality of life and overall rates of adverse events.