OBJECTIVES: There are 3 key challenges for any anti-infectives business model: the “save the best for last” approach, uncertain evolution of epidemiology and future resistance and lastly less than comprehensive evidence packages. The aim of this research was to address the later, to get a better understanding of key drivers of value and how to optimise evidence package to achieve favourable P&R and access. METHODS: An analogue analysis was undertaken to gain insights from the experience of previous launches. This involved in-depth desk research looking in to 10 anti-infectives launched in the last decade, their treatment landscape at time of launch, HTA outcomes and P&R decisions made in EU5. This was followed by 1 hour telephone interviews with 4-5 key Payer archetypes from each market. RESULTS: All products launched in therapy spaces served by cheap generics. No direct relation is observed between comparator prices and prices achieved. All were able to achieve a substantial premium over comparators, from 3X to 1000X in some cases. The key driver for this was the high unmet need, particularly for severe and resistant diseases, in hospitalised patients and lack of alternatives. CONCLUSIONS: From Payer’s perspective, hard end points such as reduction of viral and bacterial load is critical, while QoL is not considered important and surrogate endpoints are generally not accepted. In hospital setting, DRG (disease-related group) tariffs could also be a limiting factor on price potential. Without clear clinical and economical benefit, potential anti-infectives risk being relegated to last-line of treatment. Differentiation from existing SoC on key endpoints, clinically and economically, is necessary for positive P&R and access.