OBJECTIVES: Acute microbial infections represent a major health burden globally, causing ~15 million deaths annually. Research and development have largely focused on or restricted to treatment of hospitalised patients. However, all cases of acute infections are initially treated in an outpatient setting. The aim of this research was to understand the burden of illness in outpatient setting, understand key drivers of value and challenges impacting market access of potential products targeting outpatients.

METHODS: A comprehensive literature review was done using PubMed databases for the last decade on diagnosis and management of select infectious diseases. Additional desk research was conducted looking in to 10 anti-infectives launched in the last decade, their HTA outcomes and P&R decisions made in EU5, followed by 1-hour telephone interviews with 4-5 key Payer archetypes from each market.

RESULTS: Literature review show that majority of the patients with acute infections are initially treated in an ambulatory or emergency department setting, with only 10-20% of those cases requiring hospitalisation. Further, there is a substantial shift in management in outpatient settings. With overlapping disease presentations and with only symptomatic management available in most cases, identification of pathogen is not considered essential. Recent products launched for acute infections are able to achieve relatively high prices in the range of 3X-1000X versus respective comparators, they are restricted to select and often hospitalised patients.

CONCLUSIONS: The burden of disease in outpatient setting from acute infections is substantial. A key hurdle for access is the routine identification of pathogens in outpatient settings. This firstly impactsaccurately defining infection attributed mortality and resource use. It would also be critical to overcome Payer tendency to restrict prescription to a defined population and to ‘save the best for last’ applied to all recent launches. Improvements on time to symptom resolution and reduction in hospitalisations will be key drivers of value.