Guidance for Demonstrating the Societal Value of new Antibiotics

Abstract

Given that antibiotic use is associated with externalities, standard economic evaluation which considers costs and health gains accruing to patients under-values antibiotics. Informed by a scoping review, this discussion paper aims to identify the societal value elements of antibiotics and to provide guidance on how these value elements can be incorporated in economic evaluation. With a view to appropriately quantify the societal value of antibiotics, there is a need for good practice guidelines on the methodology of economic evaluation for such products. We argue that it is important to assess antibiotics at population level to account for their transmission, diversity, insurance, spectrum, novel action and enablement values. In addition to the value of antibiotics to infected patients, economic evaluations need to use modeling approaches to explore the impact of different modes of employing new and existing antibiotics (for example, as last resort treatment) on disease transmission and resistance development in current and future patients. Hence, assessing the value of antibiotics also involves an ethical dimension. Further work is required about how the multiple value elements of antibiotics are linked to each other and how they can be aggregated.

Critical Reflections on Reimbursement and Access of Advanced Therapies

“…Although accounting for the characteristics of advanced therapies runs the risk that these products are treated in a different way from a health economic perspective than other medicines, there have been numerous calls from various stakeholders in multiple countries to apply specific considerations to the reimbursement and market access of advanced therapies ( van Overbeeke et al, 2021 ). This is similar to the way that other types of innovative medicines such as (ultra-)orphan drugs ( Nestler-Parr et al, 2018 ), antibiotics ( Simoens and Spriet, 2020 ), or vaccines ( Annemans et al, 2021 ) may receive special attention in value assessment and reimbursement.…”

Improving health evaluations to capture wider value of therapeutics and incentivise innovation

“…There are no established methods for assessing broader value, despite numerous recommendations to consider them for novel antimicrobials and vaccines (3,(10)(11)(12). Key elements of this broader value include insurance value and enablement value (3,6,10,14).…”

“…Thirdly, there is increasing appetite for Outcomes Based Agreements to better align commercial arrangements around patient value. Finally, broader frameworks for valuing novel antimicrobials and vaccines (3,5,6,(10)(11)(12) have also been recommended internationally.…”

Perspectives on the Ethics of Antibiotic Overuse and on the Implementation of (New) Antibiotics

“…For educational purposes, the same group of stakeholders need to address customized aspects of political, socio-economic, commercial and cultural ethics if the different stakeholders in antibiotic overuse are to be persuaded to change their current practices [ 45 , 47 ]. In this way, ethical considerations should be balanced between the conservation of existing antibiotics, the acceleration of new antibiotic development, potential regulatory hurdles and the conservation of antibiotic safety and efficacy [ 48 , 49 ].…”