Dzintars Gotham1, Lorenzo Moja2, Maarten van der Heijden3, Sarah Paulin4, Ingrid Smith5, Peter Beyer6. 1. Independent Researcher, London, UK. Electronic address: dzintarsgotham@gmail.com. 2. Department of Health Products Policy and Standards, World Health Organization, 20 Avenue Appia, 1211, Geneva, Switzerland. Electronic address: mojal@who.int. 3. Department of Coordination and Partnership on AMR, AMR Division, World Health Organization, 20 Avenue Appia, 1211, Geneva, Switzerland. Electronic address: vanma@who.int. 4. Department of Coordination and Partnership on AMR, AMR Division, World Health Organization, 20 Avenue Appia, 1211, Geneva, Switzerland. Electronic address: paulins@who.int. 5. Research and Development Department, Haukeland University Hospital, Bergen, Norway. Electronic address: ismith@who.int. 6. Department of Coordination and Partnership on AMR, AMR Division, World Health Organization, 20 Avenue Appia, 1211, Geneva, Switzerland. Electronic address: beyerp@who.int.
Abstract
INTRODUCTION: The pipeline of new antibacterials remains limited. Reasons include low research investments, limited commercial prospects, and scientific challenges. To complement existing initiatives such as research grants, governments are exploring policy options for providing new market incentives to drug developers. MATERIALS AND METHODS: Reimbursement interventions for antibacterials in France, Germany, Sweden, US, and UK were reviewed and analysed by the authors. RESULTS: In France, Germany, and the US, implemented interventions centre on providing exceptions in cost-containment mechanisms to allow higher prices for certain antibacterials. In the US, also, certain antibacterials are granted additional years of protection from generic competition (exclusivity) and faster regulatory review. The UK is piloting a model that will negotiate contracts with manufacturers to pay a fixed annual fee for ongoing supply of as many units as needed. Sweden is piloting a model that will offer manufacturers of selected antibacterials contracts that would guarantee a minimum annual revenue. A similar model of guaranteed minimal annual revenues is under consideration in the US (PASTEUR Act). CONCLUSIONS: The UK and Sweden are piloting entirely novel procurement and reimbursement models. Existing interventions in the US, France, and Germany represent important, but relatively minor interventions. More countries should explore the use of novel models and international coordination will be important for 'pull' incentives to be effective. If adopted, the PASTEUR legislation in the US would constitute a significant 'pull' incentive.
INTRODUCTION: The pipeline of new antibacterials remains limited. Reasons include low research investments, limited commercial prospects, and scientific challenges. To complement existing initiatives such as research grants, governments are exploring policy options for providing new market incentives to drug developers. MATERIALS AND METHODS: Reimbursement interventions for antibacterials in France, Germany, Sweden, US, and UK were reviewed and analysed by the authors. RESULTS: In France, Germany, and the US, implemented interventions centre on providing exceptions in cost-containment mechanisms to allow higher prices for certain antibacterials. In the US, also, certain antibacterials are granted additional years of protection from generic competition (exclusivity) and faster regulatory review. The UK is piloting a model that will negotiate contracts with manufacturers to pay a fixed annual fee for ongoing supply of as many units as needed. Sweden is piloting a model that will offer manufacturers of selected antibacterials contracts that would guarantee a minimum annual revenue. A similar model of guaranteed minimal annual revenues is under consideration in the US (PASTEUR Act). CONCLUSIONS: The UK and Sweden are piloting entirely novel procurement and reimbursement models. Existing interventions in the US, France, and Germany represent important, but relatively minor interventions. More countries should explore the use of novel models and international coordination will be important for 'pull' incentives to be effective. If adopted, the PASTEUR legislation in the US would constitute a significant 'pull' incentive.
Authors: Mark S Butler; Valeria Gigante; Hatim Sati; Sarah Paulin; Laila Al-Sulaiman; John H Rex; Prabhavathi Fernandes; Cesar A Arias; Mical Paul; Guy E Thwaites; Lloyd Czaplewski; Richard A Alm; Christian Lienhardt; Melvin Spigelman; Lynn L Silver; Norio Ohmagari; Roman Kozlov; Stephan Harbarth; Peter Beyer Journal: Antimicrob Agents Chemother Date: 2022-01-10 Impact factor: 5.191
Authors: Tetsuya Matsumoto; Akira Yuasa; Ryan Miller; Clive Pritchard; Takahisa Ohashi; Amer Taie; Jason Gordon Journal: Pharmacoecon Open Date: 2022-09-15
Authors: Dana M Klug; Fahima I M Idiris; Mark A T Blaskovich; Frank von Delft; Christopher G Dowson; Claas Kirchhelle; Adam P Roberts; Andrew C Singer; Matthew H Todd Journal: Wellcome Open Res Date: 2021-06-11