How Should the Value Attributes of Novel Antibiotics Be Considered in Reimbursement Decision Making?

Abstract

Antibiotics have revolutionized the treatment of bacterial infections. However, it is widely held that there is underinvestment in antibiotics research and development relative to the socially optimal level for a number of reasons. In this article, we discuss whether existing health technology assessment procedures recognize the full economic and societal value of new antibiotics to patients and society when making reimbursement decisions. We present three recommendations for modelling the unique attributes of value that are specific to novel antibiotics. We find, based on a review of the literature, that some of the value elements proposed by our framework have previously been discussed qualitatively by health technology assessment bodies when evaluating antibiotics, but are not yet formally captured via modelling. We present a worked example to show how it may be possible to capture these dimensions of value in a more quantitative manner. We conclude by answering the question of the title as follows: the unique attributes of novel antibiotics should be considered in reimbursement decision making, in a way that captures the full range of benefits these important technologies bring to patients, health care systems, and society.

Guidance for Demonstrating the Societal Value of new Antibiotics

“…This approach was adopted, for instance, in an economic evaluation of a new antibiotic to treat intensive care unit patients infected with Acinetobacter baumannii ( Rothery et al, 2018 ). In another economic evaluation, transmission and diversity value was incorporated by adding related costs and health outcomes to the numerator and denominator, respectively, of the incremental cost-effectiveness ratio of the antibiotic ( Morton et al, 2019 ).…”

“…Furthermore, the experience with antibiotic assessment practices in Europe indicates that the different value elements of antibiotics are not taken into account systematically by reimbursement agencies and, at best, are considered in a qualitative manner. For instance, surveys have shown that the impact on antimicrobial resistance has been mentioned or implied in economic evaluations of individual antibiotics submitted to reimbursement agencies, but this and other values were not incorporated in a structured way in the ultimate decisions ( Charafi and Chen, 2017 ; Morton et al, 2019 ).…”

“…In an illustrative example of a hypothetical antibiotic to treat Acinetobacter baumannii infections, the incremental cost-effectiveness ratio of €36,570 per QALY gained in the standard economic evaluation improved to €4,318 per QALY gained in the economic evaluation that also accounted for transmission value. The health gain derived from avoided infections of 33,178 QALYs at population level surpassed the health gain accruing to patients of 12,442 QALYs ( Morton et al, 2019 ). Another economic evaluation demonstrated that the inclusion of transmission value had a large positive impact on the cost-effectiveness of treating multidrug-resistant tuberculosis ( Resch et al, 2006 ).…”

“…Given that it is difficult to model the impact of an antibiotic on resistance development to other antibiotics, it has been argued that a formal expert elicitation exercise needs to be conducted to estimate the cost savings and health gains arising from lower selection pressure on these other antibiotics. This approach was followed in the previously mentioned example of a hypothetical antibiotic to treat Acinetobacter baumannii infections: the incremental cost-effectiveness ratio of the hypothetical antibiotic fell to €3,659 per QALY gained in the economic evaluation that also accounted for transmission and diversity values, and the health gain derived from avoiding resistant infections amounted to 2,752 QALYs ( Morton et al, 2019 ).…”

Financing Pull Mechanisms for Antibiotic-Related Innovation: Opportunities for Europe

“…Some countries are examining the potential to adjust the prices of new antibiotics to be commensurate with the value not only for the patient but also society. Several different types of indirect societal values have been described and formulas devised, including transmission value (an antibiotic’s ability “to reduce transmission rates in the general population”) and diversity value (an antibiotic’s potential “to curb resistance through a reduction in selection pressure”) [ 19 , 20 ]. Including indirect effects may allow an antibiotic to achieve a higher unit price.…”