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A Perspective on Incentives for Novel Inpatient Antibiotics: No One-Size-Fits-All

Published online by Cambridge University Press:  01 January 2021

Extract

The need for new “pull” incentives to stimulate antibiotic R&D is widely recognized. Due to the global diversity of health systems, combined with different challenges faced by antibiotics used in different types of healthcare settings, there is no one-size-fits-all solution. Instead, different “pull” incentives should be tailored to local contexts, priorities, and antibiotic types. Policymakers and industry should collaborate to identify appropriate solutions at the local, regional, and global levels.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

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References

Renwick, M. J., Brogan, D. M., and Mossialos, E., “A Systematic Review and Critical Assessment of Incentive Strategies for Discovery and Development of Novel Antibiotics,” Journal of Antibiotics 69 (2016): 7388j.CrossRefGoogle Scholar
Pew Charitable Trust, “Antibiotics Currently in Clinical Development,” updated 2017, available at <http://www.pewtrusts.org/en/multimedia/data-visualizations/2014/antibiotics-currently-in-clinical-development> (last visited March 22, 2018).+(last+visited+March+22,+2018).>Google Scholar
The Review on Antimicrobial Resistance: Chaired by O'Neil, Jim, Tackling Drug-Resistant Infections Globally: Final Report and Recommendations, May 2016; World Bank, Drug-Resistant Infections: A Threat to Our Economic Future (Discussion Draft), 2016, Washington, D.C.Google Scholar
Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance, January 2016, available at <https://www.ifpma.org/wp-content/uploads/2016/01/Industry_Declaration_on_Combating_Antimicrobial_Resistance_UPDATED-SIGNATORIES_MAY_2016.pdf> (last visited March 22, 2018); Industry Roadmap for Progress on Combating Antimicrobial Resistance, September 2016, available at <https://www.ifpma.org/wp-content/uploads/2016/09/Roadmap-for-Progress-on-AMR-FINAL.pdf> (last visited August 15, 2017).+(last+visited+March+22,+2018);+Industry+Roadmap+for+Progress+on+Combating+Antimicrobial+Resistance,+September+2016,+available+at++(last+visited+August+15,+2017).>Google Scholar
Silver, L. L., “Challenges of Antibacterial Discovery,” Clinical Microbiology Reviews 24, no. 1 (2011): 71109.Google Scholar
Rex, J. H., Goldberger, M., Eisenstein, B. I., and Harney, C., “The Evolution of the Regulatory Framework for Antibacterial Agents, ” Annals of the New York Academy of Science 1323 (2014): 1121.CrossRefGoogle Scholar
See supra note 3 for reference to The Review on AMR.Google Scholar
DRIVE-AB Final Report, “Revitalizing the Antibiotic Pipeline: Stimulating Innovation While Driving Sustainable Use and Global Access,” at 2728, 2018, available at <http://www.imi.europa.eu/projects-results/project-factsheets/drive-ab> (March 22, 2018).+(March+22,+2018).>Google Scholar
Sommer, M. O. A., Munck, C., Toft-Kehler, R.V., Andersson, D. I., “Prediction of Antibiotic Resistance: Time for a New Preclinical Paradigm?” Nature Reviews Microbiology 15 (2017): 689696.CrossRefGoogle Scholar
Kinch, M. S., “ An Overview of FDA-Approved Biologics Medicines, ” Drug Discovery Today 20, no. 4 (2015): 393398.Google Scholar
See Rendwick et al., supra note 1.Google Scholar
See DRIVE-AB Final Policy Report, supra note 8.Google Scholar
Outterson, K., New Business Models for Sustainable Antibiotics, 2014, available at <https://www.chathamhouse.org/sites/files/chathamhouse/public/Research/Global%20Health/0214SustainableAntibiotics.pdf> (last visited March 22, 2018).+(last+visited+March+22,+2018).>Google Scholar
Chorzelski, S. et al., Breaking through the Wall: Enhancing Research and Development of Antibiotics in Science and Industry, Global Union for Antibiotic Research & Development Initiative (2015), available at <https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/G/G7/Qualitaetswettbewerb_Gesundheitssystem_Whitepaper_2015-10-02.pdf> (last visited March 22, 2018).+(last+visited+March+22,+2018).>Google Scholar
International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Policy Position: Sustainable Models to Overcome the Challenging Economics of Antimicrobial R&D, available at <http://partnerships.ifpma.org/uploads/documents/218_1485276320.pdf> (last visited March 22, 2018).+(last+visited+March+22,+2018).>Google Scholar
Goldhammer, J., Mitchel, K., Parker, A., Anderson, B., and Sahil, J., “The Craft of Incentive Prize Design: Lessons from the Public Sector,” 2014, available at <https://www.issuelab.org/resource/the-craft-of-incentive-prize-design-lessons-from-the-public-sector.html> (March 22, 2018); see Rendwick et al., supra note 1; J. H. Rex and K. Outterson, “Antibiotic Reimbursement in a Model Delinked from Sales: A Benchmark-Based Worldwide Approach,” The Lancet Infectious Diseases 16, no. 4 (2016): 500-505.+(March+22,+2018);+see+Rendwick+et+al.,+supra+note+1;+J.+H.+Rex+and+K.+Outterson,+“Antibiotic+Reimbursement+in+a+Model+Delinked+from+Sales:+A+Benchmark-Based+Worldwide+Approach,”+The+Lancet+Infectious+Diseases+16,+no.+4+(2016):+500-505.>Google Scholar
Id. (Rex and Outterson); Daniel, G., Schneider, M., and McClellan, M., “Addressing Antimicrobial Resistance and Stew-ardship: The Priority Antimicrobial Value and Entry (PAVE) Award,” JAMA 318, no. 12 (2017): 11031104.CrossRefGoogle Scholar
See supra notes 13 (The Review on AMR reference), 15 (Chorzelski et al.), and 16 (IFPMA policy position).Google Scholar
Viale, P., Giannella, M., Lewis, R., Trecarichi, E. M., Petrosillo, N., Tumbarello, M., “Predictors of Mortality in Multidrug-Resistant Klebsiella Pneumoniae Bloodstream Infections,” BioMed Central Infectious Disease 14 (2014): 572; A. F. Shorr, M. D. Zilberberg, S. T. Micek, and M. H. Kollef, “Predictors of Hospital Mortality among Septic ICU Patients with Acinetobacter spp.bacteremia: A Cohort Study,” Expert Review of Anti-Infective Therapy 11, no. 10 (2013): 1053-1063; T. P. Lodise, N. Patel, A. Kwa, J. Graves, J. P. Furuno, E. Graf-funder, B. Lomaestro, and J. C. McGregor, “Predictors of 30-Day Mortality among Patients with Pseudomonas Aeruginosa Bloodstream Infections: Impact of Delayed Appropriate Antibiotic Selection,” Antimicrobial Agents Chemotherapy 51, no. 10 (2007): 3510-3515.Google Scholar
Kesselheim, A. S. and Outterson, K., “Fighting Antibiotic Resistance: Marrying New Financial Incentives to Meeting Public Health Goals,” Health Affairs 29, no. 9 (2010): 16891696; A. Sertkaya, J. T. Eyraud, A. Birkenbach, et al., “Analytical Framework for Examining the Value of Antibacterial Products,” available at <https://aspe.hhs.gov/report/analytical-framework-examining-value-antibacterial-products> (last visited March 22, 2018).Google Scholar
DRIVE-AB, Incentives to Stimulate Antibiotic Innovation: The Preliminary Findings of DRIVE-AB, available at <http://drive-ab.eu/wp-content/uploads/2016/06/WP2-Prereading-FINAL.pdf> (last visited March 22, 2018).+(last+visited+March+22,+2018).>Google Scholar
See Daniel et al., supra note 18.Google Scholar
European Commission, A European One Health Action Plan against Antimicrobial Resistance (AMR), available at <https://ec.europa.eu/health/amr/sites/amr/files/amr_action_plan_2017_en.pdf> (last visited March 22, 2018).+(last+visited+March+22,+2018).>Google Scholar
Schaffer, S. K., West, P., Towse, A., Henshall, C., Mestre-Ferrandiz, J., Masterton, R., and Fischer, A., Assessing the Value of New Antibiotics: Additional Elements of Value for Health Technology Assessment Decisions, Office of Health Economics, May 2017, available at <https://www.ohe.org/system/files/private/publications/OHE%20AIM%20Assessing%20The%20Value%20of%20New%20Antibiotics%20May%202017.pdf> (last visited March 22, 2018).Google Scholar
See DRIVE-AB Final Policy Report, supra note 8, at at 27-28.Google Scholar
Id., and Schaffer et al., supra note 25.Google Scholar