Time for a change in how new antibiotics are reimbursed: Development of an insurance framework for funding new antibiotics based on a policy of risk mitigation

Время изменить подход к возмещению затрат на новые антибиотики: разработка страховой модели финансирования новых антибиотиков на основе политики снижения рисков
Adrian Towse, Christopher Hoyle, Jonathan J. Goodall, Mark Hirsch, Jorge Mestre‐Ferrandiz, John Rex
2017-08-05

antibiotic conservationantibiotic reimbursementinsurance modelmultidrug-resistant pathogensnew antibiotics
Healthcare systems depend on the availability of new antibiotics. However, there is a lack of treatments for infections caused by multidrug resistant (MDR) pathogens and a weak development pipeline of new therapies. One core challenge to the development of new antibiotics targeting MDR pathogens is that expected revenues are insufficient to drive long-term investment. In the USA and Europe, financial incentives have focussed on supporting R&D, reducing regulatory burden, and extending market exclusivity. Using resistance data to estimate global revenues, we demonstrate that the combined effects of these incentives are unlikely to rekindle investment in antibiotics. We analyse two supplemental approaches: a commercial incentive (a premium price model) and a new business model (an insurance model). A premium price model is familiar and readily implemented but the required price and local budget impact is highly uncertain and sensitive to cross-sectional and longitudinal variation in prevalence of antibiotic resistance. An insurance model delivering risk mitigation for payers, providers and manufacturers would provide an incentive to drive investment in the development of new antibiotics while also facilitating antibiotic conservation. We suggest significant efforts should be made to test the insurance model as one route to stimulate investment in novel antibiotics.
1
A premium-price model is straightforward to implement, but its required pricing and budget impact are highly uncertain because resistance prevalence varies across locations and over time.
2
An insurance-based reimbursement model could mitigate financial risks for payers, providers, and manufacturers, thereby encouraging antibiotic development while supporting antibiotic conservation.
3
Current incentives supporting antibiotic R&D, regulatory approval, and market exclusivity are unlikely to restore investment in new antibiotics targeting multidrug-resistant pathogens.
4
Revenue estimates incorporating antimicrobial-resistance data indicate that expected returns remain insufficient to sustain long-term antibiotic development.
5
The insurance model should be substantially tested as a potential strategy for stimulating investment in novel antibiotics.

Development and reimbursement funding of new antibiotics targeting multidrug-resistant pathogens

reimbursement and funding mechanisms—particularly a risk-mitigation insurance model—for stimulating investment in antibiotic development while facilitating antibiotic conservation

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2017-08-05
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Adrian Towse
Christopher Hoyle
Jonathan J. Goodall
Mark Hirsch
Jorge Mestre‐Ferrandiz
John Rex
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