Addressing challenges along the ‘access cascade’ for new TB regimens

This is a decisive moment with multiple new chemical entities progressing through the TB drug pipeline. Our review aims to contribute to policy discussion around these new TB treatments, primarily to increase the chance of successfully and rapidly adopting new regimens where they are most needed. Our analysis is based on: i) stakeholder engagement efforts undertaken in the context of UNITE4TB (a global clinical trial consortium for development of new TB drugs and regimens), ii) the outcomes of a special session of the UNITE4TB Annual Meeting 2024 in which representatives from several key stakeholder groups (pharmaceutical, clinical, research, regulatory, oversight, and advocacy) spoke on the topic of access to new TB regimens; and iii) a review of the literature. We propose a model for an 'access cascade' detailing the necessary steps from early research and development to the introduction of new regimens into clinical care. We then determined potential bottlenecks that might impede equitable access to new TB regimens globally, and conclude with recommended actions for stakeholders to take to overcome or mitigate the effects of these bottlenecks.