Determinants of price negotiations for new drugs. The experience of the Italian Medicines Agency |
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| Institution: | 1. Italian Medicines Agency (AIFA), Via del Tritone, 181 - 00187, Rome, Italy;2. Department of Pharmaceutical Sciences, Università del Piemonte Orientale, Largo Guido Donegani, 2 – 28100, Novara, Italy;3. Utrecht University, Heidelberglaan 8, 3584 CS Utrecht, NL;4. Professor of Practice, Government, Health and Not for Profit Division, SDA Bocconi School of Management, Via Bocconi 8, 20136, Milan, Italy;1. Department of Sociology, University of Cambridge, 16 Mill Lane, CB2 1 SB, Cambridge, United Kingdom;2. Doctoral School of Pharmacological and Pharmaceutical Sciences, University of Pécs, Hungary;3. Syreon Research Institute, Budapest, Hungary;4. Department of Social and Policy Sciences, University of Bath, Bath, United Kingdom;5. Department of Health Policy and Health Economics, Eötvös Loránd University, Budapest, Hungary;6. Department of Economics, University of Massachusetts, Amherst, MA, United States;7. Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom;1. London School of Economics and Political Science, Health Policy, United Kingdom;2. Center for Research in Health and Economics (CRES), University Pompeu Fabra, Spain;3. Research Group on Statistics, Econometrics and Health (GRECS), University of Girona, Spain;4. London School of Hygiene and Tropical Medicine, United Kingdom;5. CCBIO, University of Bergen, Norway;1. Centre for Research on Health and Social Care Management, Bocconi University, Via Roentgen 1, 20126 Milan, Italy;2. Department of Social Policy, London School of Economics and Political Science, Houghton Street, WC2A 2AE, London, United Kingdom;3. Department of Public Health, Ghent University, De Pintelaan 185, 4K3, 9000 Gent, Belgium;4. Department of Finance, University of Vienna, Oskar-Morgenstern-Platz 1 (6th floor), 1090 Vienna, Austria;5. Scottish Medicines Consortium, Delta House (8th floor), 50 West Nile Street, G1 2NP Glasgow, Scotland, United Kingdom;6. Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, 10 Spring Gardens, SW1A 2BU London, United Kingdom;7. Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Nine Edinburgh BioQuarter, 9 Little France Road, EH16 4UX Edinburgh, Scotland, United Kingdom;1. Department of Biomedical and Biotechnological Sciences, University of Catania, University of Catania, Catania, Italy;2. Department of Pharmaceutical Sciences, University of Eastern Piedmont, Alessandria, Italy;3. A.O.U. Policlinico – Vittorio Emanuele, Catania, Italy;4. Department of Economics and Quantitative Methods, University of Catania, Catania, Italy;1. School of Public Health, Shanghai Jiao-Tong University, Shanghai, China;2. James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA;3. National School of Development, Peking University, Beijing, China;4. School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China;5. 306 Hospital of PLA, Beijing, China;6. National Institute for Social Security Research, China;7. School of Public Health, Fu-Dan University, Shanghai, China;1. School of Pharmacy, Sungkyunkwan University, Suwon, South Korea;2. College of Pharmacy, Yonsei Institute of Pharmaceutical Sciences, Yonsei University, Incheon, South Korea;3. Department of Benefits Management, National Health Insurance Service (NHIS), Wonju, South Korea |
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| Abstract: | ObjectivesThe aim of this paper is to investigate the determinants of the difference between the price proposal submitted by the industry and the final negotiated price. We used Italy as a case-study.MethodsData were gathered through the information system used by Italian Medicines Agency. The time-frame for this analysis is 2013–2017. Factors influencing the delta price were analyzed through a regression analysis.Results44 orphan drugs and 89 new other molecular entities obtained reimbursement in the last five years. Following the negotiation process, prices were lowered by 25.1% and 28.6% on average for orphan drugs and other molecules respectively. The price reduction was higher for innovative drugs (-32.2%). Statistically significant determinants associated to higher price reduction were: i) the implementation of a product specific monitoring registry, ii) the negotiation of a financial-based Managed Entry Agreement, iii) a target population larger than 20,000 patients, iv) an expected National Health Service expenditure larger than €200 million.DiscussionThe impact of some variables on the delta price was predictable (e.g. for drugs with an expected higher budget impact and a larger population target), others were more surprising (e.g. a significant price reduction for “innovative” drugs). The implementation of financial-based agreements, which often rely on confidential arrangements, was one of the determinants with higher impact on price reduction. |
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| Keywords: | Market access Value-based pricing AIFA Italy Managed entry agreements Delta price Drug price negotiation Health technology assessment |
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