Driving reinvestment in R&D for antibiotics and advocating their responsible use

WHAT IS DRIVE-AB?

DRIVE-AB (Driving reinvestment in research and development and responsible antibiotic use) is a project composed of 15 public and 7 private partners from 12 countries that is funded by the Innovative Medicines Initiative (IMI): IMI is a joint undertaking between the European Union and the European Pharmaceutical Industry Association (EFPIA).

DRIVE-AB is tasked with defining responsible use of antibiotics, identifying the antibiotic-related public health priorities, calculating the societal value of having new antibiotics available for these priorities, developing and costing new economic models to promote the desired antibiotic innovation, and sustainable use of the resulting, novel antibiotics. The purpose of the project is to transform the way policymakers stimulate antibiotic innovation and to ensure that these new antibiotics are used sustainably and available equitably.

THE PROBLEM DRIVE-AB SEEKS TO ADDRESS

Antimicrobial resistance (AMR) is widespread. Its global human and economic burden is tremendous and increasing annually. Yet today only four among scores of pharmaceutical companies retain active antibacterial drug discovery programmes; a mere two of these have a novel antibiotic in phase 2 development. While the elaboration of antibiotics with novel mechanisms of action is scientifically complex, the chief challenge is diminishing commercial incentives. Pre-market regulatory requirements and increased control on post-market access, use, and pricing of new antibiotics are strong deterrents to drug development companies. Meanwhile, healthcare payers are not currently prepared to reimburse antibiotics at prices that would support the investments in development.

Applied to antibiotics, a simple sales-based economic model contradicts the public health mandate to reduce their consumption in order to preserve their efficacy. Alternative models that can create incentives for the discovery and development of novel antibiotics and yet reconcile these incentives with responsible antibiotic use are long overdue.

HOW DRIVE-AB WILL WORK TO PROVIDE SOLUTIONS

The multidisciplinary and multi-stakeholder DRIVE-AB consortium, composed of 16 public and 7 private partners from 12 countries, will produce such models in a stepwise yet interconnected process. First, we will develop an evidence-based, consensus definition for “responsible antibiotic use,” which, with its standardised quality and quantity indicators, will provide the framework for all later steps. Next, data from surveillance systems, antibiotic prescription databases, and published literature will inform estimations of the present burden of antibiotic resistance from both clinical and economic perspectives across varying socioeconomic backdrops. Simulation models informed by these data as well as data from past and ongoing epidemics will estimate future public health needs and impact related to antibacterial resistance, again in diverse socioeconomic settings.

Together these constructs will allow for valuation models that will estimate the true value of new and existing antibiotics from the perspectives of patients, physicians, payers, and society as a whole. These, in turn, will inform the creation of alternative economic strategies and reward models that will promote and sustain the development of new antibiotics while simultaneously bolstering appropriate consumption of existing antibiotics. The most promising schemes will be presented to policymakers and other stakeholders with attendant implementation and risk-management strategies.

This ambitious project will not succeed if it is developed and championed merely by one sector of society, be it academia, “big pharma,” or public health. The robustness and applicability of the proposed alternative models will only be proportional to their level of input from all involved players. All work from beginning to end will be performed in close collaboration with the consortium’s stakeholder partners, which run the gamut from patients and clinical societies to small- and medium-sized enterprises, large pharmaceutical companies, healthcare payers, public health officials, and government officials. The DRIVE-AB consortium will dedicate considerable resources to this collaboration and to the final dissemination of information to policymakers and the wider public.

WANT MORE INFORMATION?

For more information about the project, see our DRIVE-AB Info Package.

Take a look at our full DRIVE-AB overview:

General Info Package A4 Preview Image

For more posters and handouts summarizing the issue of antibiotic resistance and DRIVE-AB’s role in creating solutions, please see our DRIVE-AB Outputs: Posters and Handouts.

Or, for more specific questions, contact us.


ARE YOU INTERESTED IN BECOMING A STAKEHOLDER?

Please fill out our short Expression of Interest form, and we will add you to our stakeholder list.