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

WP2: Creation and testing of new economic models

LEADERS
Academic:
Franceso Ciabuschi, Uppsala University, Sweden
Federal: Christine Årdal, Norwegian Institute of Public Health, Norway
EFPIA: David Findlay, GlaxoSmithKline Research and Development

PARTNERS
E. Mossialos (London School of Economics), C. Morel, E. Baraldi, S. McKeever, F. Ciabuschi, A. Waluszewski, B. Domeij, C. Okhravi, C. Koerber, O. Lindahl, D. Kronlid, G. Sigeman (Uppsala University), O. Cars, A. Zorzet (Uppsala University and ReAct) J. Plahte, C. Årdal and C. Kållberg, D. Gouglas, E. Nwokoro (Norwegian Institute of Public Health), F. Aftab (Norwegian Institute of Public Health and University of Oslo), K. Outterson (Chatham House and Boston School of Law)

The private partners in DRIVE-AB are: AstraZeneca AB, GlaxoSmithKline Research & Development, F. Hoffmann-La Roche Ltd, MSD, Astellas Pharma Europe LTD and Pfizer Limited

KEY MESSAGES

  1. The antibiotic business model is broken; stewardship dramatically limits new antibiotic sales. So the historic price/volume model for generating revenues is not effective in generating an attractive return and considered inappropriate in light of resistance.  As a result of these low returns on antibacterial R&D investment, companies have increasingly steered their investments to other therapy areas.
  2. Many reward mechanisms to incentivize greater investment in antibiotic R&D have been suggested but few have been tested. DRIVE-AB will quantitatively model and test the most promising mechanisms against both profitability and public health benefit. This will include in-depth analysis of the entire economic model, covering the value chain from basic science to treatment of patients. Responsible use interventions will be included in the simulations and evaluations.
  3. Any new economic model must have built in provisions for equitable and appropriate patient access since today the greatest problem is still that there is far more morbidity and mortality from a lack of access to appropriate antibiotics than from antibiotic resistance

OBJECTIVES

  1. Bring stakeholders on board at the outset and use their critical insights to help shape the project
  2. Assess the specific bottlenecks and risk perceptions affecting the development of antibiotics
  3. Evaluate reward and business models in other industries that also support stewardship and conservation or address key challenges similar to antibiotics
  4. Develop, exhaustively analyse, validate, and explore in detail the implementation of the most promising reward models (those that deliver the greatest public health benefit with an acceptable net present value [NPV]), including funding sources, that will increase and sustain investment in antibiotic R&D while encouraging stewardship and conservation
  5. Further validate the most promising reward models against a set of public health policy recommendations focused on antibiotics stewardship, including measures to support appropriate use
  6. Gain buy-in from all stakeholders on our recommendations and receive endorsement from policymakers regarding our implementation plan

HIGH-LEVEL PARAMETERS

  1. DRIVE-AB’s recommendations will focus only on antibiotics, not all antimicrobials.
  2. DRIVE-AB is only one component in a multi-faceted effort to combat antibiotic resistance. DRIVE-AB will issue recommendations on how to strengthen innovation of antibiotic and related technologies. We will not address non-investment related aspects of resistance such as increasing surveillance and infection control. Our recommendations will be limited to investment in antibiotics for human use only.
  3. All recommendations will reinforce responsible use of antibiotics.
  4. Our recommendations will seek change on a global scale, yet necessary scale and geographical scope for each recommendation will be analyzed and documented.
  5. Our recommendations will encourage reforms to explicitly help improve access to effective antibiotics globally. Such reforms will, however, rely on active participation of national governments, regions, multinational organizations and/or regulatory agencies in order to properly implement and ensure that the right patients receive the appropriate treatment at the right time, and at an appropriate price.
  6. Our recommendations aim to create sustainable solutions. Lack of sustainability will be treated as a major draw-back of any proposed mechanism.
  7. The incentives we recommend will be geared towards the creation of novel antibiotics intended for both hospital and community settings.
  8. Our recommendations will seek to stimulate increases in both public and private sector investments. Both sectors must increase investment levels in order to achieve sustainable solutions.
  9. We recognize that private sector actors are profit-making organizations. Any recommended solution meant to stimulate the actions of the private sector will need to include a fair profit. However, the focus of our recommended solutions will go beyond simply creating an attractive commercial case for private sector organizations. We recognize that defining “fair” is contentious.

DOWNLOADS & RESOURCES

Printable, PDF version of the Work Package 2 Vision, Key Messages, and High-Level Parameters.
For more detail about Work Package 2 progress, please see our past NEWSLETTERS.

To get involved as a stakeholder, see the group’s STAKEHOLDER ENGAGEMENT PAGE.

OUTPUTS

Report: Incentives to stimulate antibiotic innovation: The preliminary findings of DRIVE-AB

Report: Identified risks and bottlenecks to antibiotics innovation

Short Report: Solutions from other industries applicable to the antibiotic field

Publication: An antibiotic’s journey from marketing authorization to use Norway

Publication: An assessment of the future impact of alternative technologies on antibiotics markets

Publication: How to avoid a post-antibiotic world

Policy Briefs: Click here to view the full list

  1. The role for non-profit antibiotic developers
  2. The necessity for greater antibiotic innovation
  3. The Importance of Multinational Coordination and Increased Public Financing for Antibiotic Innovation

Slide Sets: Stimulating innovation, sustainable use and global access to antibiotics: DRIVE-AB Conference

Slide Set: Creating, Testing and Validating New Economic Models for Antibiotic R&D (Delivered by Christine Årdal, Norwegian Institute of Public Health, at “Stimulating the antimicrobial pipeline: A global perspective“, Washington DC, 2015)