ISSUE: There is growing concern that the pipeline of new antibiotics is insufficient to address the global public health challenge of antimicrobial resistance. One contributor to the dearth of new products may be that health payers’ assessments of novel antibiotics do not reflect the full value of those treatments, hence disincentivizing future drug development. Some have questioned whether quantifying health outcomes for a treated patient sufficiently captures the value of novel antibiotics, or whether additional elements of value associated with factors such as diversity, insurance, enablement and impact on infection transmission are relevant. If so, how can these be incorporated into the methods of economic evaluation based on the evidence available when products are licensed? Also, would a broader assessment of the value of new antibiotics be enough to bring more novel antibiotics to the market?

OVERVIEW: Many health systems and payers use economic evaluation methods to assess the value of new pharmaceuticals. Others use less formalised methods but, nonetheless, give focus to patients’ improved health outcomes as assessed in clinical trials. These methods may not fully capture the full value of novel antibiotics. Members of the panel will take different perspectives on this crucial issue. Nambiar will set the scene on the drug development and policy landscape for new antibiotics and the challenges associated with evidence development for regulatory approval. Sculpher will argue that a novel antibiotic’s value can be reflected in terms of health gains, but this needs to be at the population level and requires modelling and long-term evidence. Schneider will argue that a fuller value assessment necessitates consideration of the implications of antibiotic diversity and enablement, as well as resulting reductions infection transmission. Holland will argue that new value frameworks for novel antibiotics are needed to support greater investment in antibiotic R&D and improve patient access.