OBJECTIVES: The G-BA is often one of the first agencies to conduct an HTA. This research explored whether a major added benefit rating from the G-BA is an indicator for positive market access outcomes across several markets.

METHODS: Using Prismaccess, patient populations in the G-BA which have received major added benefit from January 2017 were extracted. These populations were matched with comparable assessments in France (TC), England (NICE), Spain (AEMPS), Australia (PBAC), and Canada (CADTH/pCODR) to compare HTA and reimbursement outcomes.

RESULTS: Since January 2017, 9 populations received major added benefit in Germany, corresponding to 6 therapies. Of these, all demonstrated improvements in morbidity, 4/9 (44%) demonstrated improvements in mortality, and 3/9 (33%) presented improvements in quality of life (QoL). In France, 5/9 (56%) populations received ASMR III, of which 3/5 (60%) mentioned a lack of QoL data. The remaining 4/9 (44%) populations received ASMR II, having demonstrated robust efficacy and QoL improvements. In England, 5/9 (56%) populations were reimbursed through specialised funding arrangements. In Australia, of the 5 populations assessed, most therapies required at least one resubmission; in their original assessments common drivers were uncertainties in the economic evaluation and price reductions.

CONCLUSIONS: Despite France and Germany being clinical effectiveness markets, a major added benefit from the G‑BA has not corresponded to an ASMR I/II from the TC. This appears to be due to the additional focus on unmet need, burden of disease and QoL in France; however, the 4 populations receiving ASMR II are therapies for Cystic Fibrosis, where the treatment focus is to improve QoL. In England, special access schemes outside the normal HTA process have been utilised for many of these therapies. In Australia, despite demonstrating clinical efficacy, the most common negative decision drivers were mainly due to cost-effectiveness and price.