Wouters, Olivier J.

Number of items: 65.
Article
  • Papanicolas, Irene, Wouters, Olivier J., Sawaya, Tania, Han, Jihye, Wei, Jinru, Naci, Huseyin (2026). Review times for new drugs and submission delays among the FDA and 4 international regulators, 2014–22. Health Affairs, 45(2), 184-192. https://doi.org/10.1377/hlthaff.2025.00595
  • Teng, Theodore W., Tu, S. Sean, Mooney, Helen, Bendicksen, Liam, Gabriele, Sarah M.E., Wouters, Olivier J., Feldman, William B. (2026). Tertiary patents on drugs approved by the FDA. JAMA Health Forum, 7(1), e255909. https://doi.org/10.1001/jamahealthforum.2025.5909
  • Cherla, Avi, Wagner, Anita K., Wouters, Olivier J., Woloshin, Steven, Davis, Courtney, Mossialos, Elias, Naci, Huseyin (2025). Reporting of clinical trial uncertainties with new cancer drugs in journal publications and clinical guidelines. JAMA, 334(16), 1480 - 1482. https://doi.org/10.1001/jama.2025.13917 picture_as_pdf
  • Vogel, Matthew, Feldman, William B., Cowan, Zander, Rome, Benjamin N., Chandra, Amitabh, Kesselheim, Aaron S., Wouters, Olivier J. (2025). Revenue differences between top-selling small-molecule drugs and biologics in medicare. JAMA Health Forum, 6(10). https://doi.org/10.1001/jamahealthforum.2025.4720
  • Wouters, Olivier J., Denolle, Cyprien, Wei, Jinru, Papanicolas, Irene (2025). Prices and affordability of essential medicines in 72 low-, middle-, and high-income markets. JAMA Health Forum, 6(8). https://doi.org/10.1001/jamahealthforum.2025.2043 picture_as_pdf
  • Vokinger, Kerstin N., Li, Guanqiao, Wouters, Olivier J. (2025). The rise of drug innovation in China - implications for patient access in the United States and globally. New England Journal of Medicine, 393(9), 839-841. https://doi.org/10.1056/NEJMp2505821
  • Cherla, Avi, Woloshin, Steven, Wagner, Anita K., Wouters, Olivier J., Davis, Courtney, Mossialos, Elias, Naci, Huseyin (2025). New cancer drug approvals: less than half of important clinical trial uncertainties reported by the FDA to clinicians, 2019–22. Health Affairs, 44(7), 830 - 838. https://doi.org/10.1377/hlthaff.2024.01134 picture_as_pdf
  • Chan, Mei Xuan Jessalyn, Wouters, Olivier J., Chan, Hui Yun, Terblanche, Petro, Premsri, Nakorn, Kim, Jerome H., Lim, John C.W., Tan-Koi, Wei Chuen, Jit, Mark (2025). Regional cooperation on pandemic preparedness and vaccine equity from an economic, regulatory and legal perspective. Vaccine, 53, https://doi.org/10.1016/j.vaccine.2025.127107
  • Fuse Brown, Erin C., Wouters, Olivier J., Mehrotra, Ateev (2025). Partnerships between pharmaceutical and telehealth companies-increasing access or driving inappropriate prescribing? New England Journal of Medicine, 392(12), 1148-1151. https://doi.org/10.1056/NEJMp2500379
  • Wouters, Olivier J., Sullivan, Sean D., Cousin, Emma M., Gabriel, Nico, Papanicolas, Irene, Hernandez, Inmaculada (2024). Drug prices negotiated by medicare vs US net prices and prices in other countries. JAMA, 333(1), 85-87. https://doi.org/10.1001/jama.2024.22582 picture_as_pdf
  • Wouters, Olivier J., Vogel, Matthew, Feldman, William B., Beall, Reed F., Kesselheim, Aaron S., Tu, S. Sean (2024). Differential legal protections for biologics vs. small-molecule drugs in the US. JAMA, 332(24), 2101 - 2108. https://doi.org/10.1001/jama.2024.16911 picture_as_pdf
  • Sullivan, Sean D., Wouters, Olivier J., Cousin, Emma M., Kirihennedige, Ayuri S., Hernandez, Inmaculada (2024). Integrating price benchmarks and comparative clinical effectiveness to inform the medicare drug price negotiation program. Value in Health, 27(10), 1348 - 1357. https://doi.org/10.1016/j.jval.2024.08.001 picture_as_pdf
  • Wouters, Olivier J., Kesselheim, Aaron S., Kuha, Jouni, Luyten, Jeroen (2024). Sales revenues for new therapeutic agents approved by the United States Food and Drug Administration from 1995 to 2014: a retrospective study. Value in Health, 27(10), 1373 - 1381. https://doi.org/10.1016/j.jval.2024.06.015 picture_as_pdf
  • Wouters, Olivier J., Kuha, Jouni (2024). Low- and middle-income countries experienced delays accessing new essential medicines, 1982–2024. Health Affairs, 43(10), 1410 - 1419. https://doi.org/10.1377/hlthaff.2024.00089 picture_as_pdf
  • Hernandez, Inmaculada, Cousin, Emma M., Wouters, Olivier J., Gabriel, Nico, Cameron, Teresa, Sullivan, Sean D. (2024). Price benchmarks of drugs selected for medicare price negotiation and their therapeutic alternatives. Journal of Managed Care & Specialty Pharmacy, 30(8), 762 - 772. https://doi.org/10.18553/jmcp.2024.24153 picture_as_pdf
  • Wouters, Olivier J., Naci, Huseyin, Papanicolas, Irene (2024). Health Technology Assessment in the US—a word of caution—reply. JAMA Internal Medicine, 184(7), 851 - 851. https://doi.org/10.1001/jamainternmed.2024.1461
  • Wouters, Olivier J., Kesselheim, Aaron S. (2024). Quantifying research and development expenditures in the drug industry. JAMA network open, 7(6). https://doi.org/10.1001/jamanetworkopen.2024.15407 picture_as_pdf
  • Wouters, Olivier J. (2024). Lobbying in US health care: lessons from the field of oncology. JNCCN, 22(4), 275 - 276. https://doi.org/10.6004/jnccn.2024.7034 picture_as_pdf
  • Wouters, Olivier J., Naci, Huseyin, Papanicolas, Irene (2024). Availability and coverage of new drugs in 6 high-income countries with health technology assessment bodies. Journal of American Medical Association: Internal Medicine, 184(3), 328 - 330. https://doi.org/10.1001/jamainternmed.2023.7726 picture_as_pdf
  • Hernandez, Inmaculada, Cousin, Emma, Wouters, Olivier J., Gabriel, Nico, Cameron, Teresa, Sullivan, Sean D. (2024). Medicare drug price negotiation: the complexities of selecting therapeutic alternatives for estimating comparative effectiveness. Journal of Managed Care & Specialty Pharmacy, 30(3), 218 - 225. https://doi.org/10.18553/jmcp.2023.23277 picture_as_pdf
  • Vokinger, Kerstin N., Perényi, Gellért, Wouters, Olivier J. (2023). Investments in research and development for supplemental drug indications: implications for drug price negotiations. JAMA Health Forum, 4(9), E232798. https://doi.org/10.1001/jamahealthforum.2023.2798 picture_as_pdf
  • Wouters, Olivier J., Forman, Rebecca, Anderson, Michael, Mossialos, Elias, McKee, Martin (2023). The launch of the EU Health Emergency Preparedness and Response Authority (HERA) improving global pandemic preparedness? Health Policy, 133, https://doi.org/10.1016/j.healthpol.2023.104844 picture_as_pdf
  • van Kessel, Robin, Forman, Rebecca, Milstein, Ricarda, Mastylak, Alicja, Czabanowska, Katarzyna, Czypionka, Thomas, Durand-Zaleski, Isabelle, Hirche, Anja, Krysinska-Pisarek, Magdalena & Roberts, Bjelle et al (2023). Divergent COVID-19 vaccine policies: policy mapping of ten European countries. Vaccine, 41(17), 2804 - 2810. https://doi.org/10.1016/j.vaccine.2023.03.036 picture_as_pdf
  • Anderson, Michael, Wouters, Olivier J., Mossialos, Elias (2023). Transferable exclusivity extensions to stimulate antibiotic research and development what is at stake? The Lancet Microbe, 4(3), e127-e128. https://doi.org/10.1016/S2666-5247(22)00336-6 picture_as_pdf
  • Angelis, Aris, Polyakov, Roman, Wouters, Olivier J., Torreele, Els, McKee, Martin (2023). High drug prices are not justified by industry’s spending on research and development. BMJ, 380(8371). https://doi.org/10.1136/bmj-2022-071710 picture_as_pdf
  • Feldman, William B., Tu, S. Sean, Alhiary, Rasha, Kesselheim, Aaron S., Wouters, Olivier J. (2023). Manufacturer revenue on inhalers after expiration of primary patents, 2000-2021. JAMA, 329(1), 87 - 89. https://doi.org/10.1001/jama.2022.19691 picture_as_pdf
  • Wouters, Olivier J., Feldman, William B., Tu, S. Sean (2022). Product hopping in the drug industry — lessons from Albuterol. New England Journal of Medicine, 387(13), 1153 - 1156. https://doi.org/10.1056/NEJMp2208613 picture_as_pdf
  • Wouters, Olivier J., Berenbrok, Lucas A., He, Meiqi, Li, Yihan, Hernandez, Inmaculada (2022). Association of research and development investments with treatment costs for new drugs approved from 2009 to 2018. JAMA network open, 5(9). https://doi.org/10.1001/jamanetworkopen.2022.18623 picture_as_pdf
  • Wouters, Olivier J., McKee, Martin, Luyten, Jeroen (2022). Errors in source data for study of drug development costs. JAMA, 328(11), p. 1110. https://doi.org/10.1001/jama.2022.14317
  • McKee, Martin, Wouters, Olivier J. (2022). The challenges of regulating artificial intelligence in healthcare comment on “Clinical decision support and new regulatory frameworks for medical devices: are we ready for it? - a viewpoint paper”. International Journal of Health Policy and Management, 12(1), 1-4. https://doi.org/10.34172/ijhpm.2022.7261 picture_as_pdf
  • Wenham, Clare, Wouters, Olivier J., Jones, Catherine M., Juma, Pamela A., Mijumbi-Deve, Rhona M., Sobngwi-Tambekou, Joëlle L., Parkhurst, Justin (2021). Measuring health science research and development in Africa: mapping the available data. Health Research Policy and Systems, 19(1). https://doi.org/10.1186/s12961-021-00778-y picture_as_pdf
  • Jit, Mark, Ananthakrishnan, Aparna, McKee, Martin, Wouters, Olivier J., Beutels, Philippe, Teerawattananon, Yot (2021). Multi-country collaboration in responding to global infectious disease threats: lessons for Europe from the COVID-19 pandemic. The Lancet Regional Health - Europe, 9, https://doi.org/10.1016/j.lanepe.2021.100221 picture_as_pdf
  • Wouters, Olivier J., Shadlen, Kenneth C, Salcher-konrad, Maximilian, Pollard, Andrew J, Larson, Heidi J, Teerawattananon, Yot, Jit, Mark (2021). Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment. The Lancet, 397(10278), 1023 - 1034. https://doi.org/10.1016/S0140-6736(21)00306-8 picture_as_pdf
  • Shi, Wunan, Wouters, Olivier J., Liu, Gordon, Mossialos, Elias, Yang, Xiuyun (2020). Association between provincial income levels and drug prices in China over the period 2010–2017. Social Science & Medicine, 263, https://doi.org/10.1016/j.socscimed.2020.113247 picture_as_pdf
  • Luyten, Jeroen, McKee, Martin, Wouters, Olivier J. (2020). Wat kost onderzoek en ontwikkeling van een medicijn? Een oproep tot meer transparantie. Nederlands Tijdschrift voor Geneeskunde, 164(34). picture_as_pdf
  • Wouters, Olivier J., McKee, Martin, Luyten, Jeroen (2020). Research and development costs of new drugs: in reply. JAMA, 324(5), p. 518. https://doi.org/10.1001/jama.2020.8651
  • van Schalkwyk, May C.I., Jarman, Holly, Hervey, Tamara, Wouters, Olivier J., Barlow, Pepita, McKee, Martin (2020). Risks to health and the NHS in the post-Brexit era. BMJ (Clinical research ed.), 369, https://doi.org/10.1136/bmj.m2307
  • Wouters, Olivier J. (2020). Lobbying expenditures and campaign contributions by the pharmaceutical and health-product industry in the United States, 1999- 2018. Journal of American Medical Association: Internal Medicine, 180(5), 688 - 697. https://doi.org/10.1001/jamainternmed.2020.0146 picture_as_pdf
  • Wouters, Olivier J., Hervey, Tamara, McKee, Martin (2020). Brexit and the European Medicines Agency—what next for the Agency and UK drug regulators? JAMA Health Forum, 1(2), E200135. https://doi.org/10.1001/jamahealthforum.2020.0135
  • Wouters, Olivier J., Sandberg, Dale M., Pillay, Anban, Kanavos, Panos (2018). The impact of pharmaceutical tendering on prices and market concentration in South Africa over a 14-year period. Social Science & Medicine, https://doi.org/10.1016/j.socscimed.2018.11.029 picture_as_pdf
  • Wouters, Olivier J., Kanavos, Panos, McKee, Martin (2017). Comparing generic drug markets in Europe and the United States: prices, volumes, and spending. The Milbank Quarterly, 95(3), 554 - 601. https://doi.org/10.1111/1468-0009.12279
  • Naci, Huseyin, Wouters, Olivier J., Gupta, Radhika, Ioannidis, John P. A. (2017). Timing and characteristics of cumulative evidence available on novel therapeutic agents receiving Food and Drug Administration accelerated approval. The Milbank Quarterly, 95(2), 261 - 290. https://doi.org/10.1111/1468-0009.12261
  • Wouters, Olivier J., Kanavos, Panos (2017). A comparison of generic drug prices in seven European countries: a methodological analysis. BMC Health Services Research, 17(242), 1-7. https://doi.org/10.1186/s12913-017-2184-5
  • Kanavos, Panos, Wouters, Olivier J. (2017). Health care after the Great Recession: financing options for sustainable and high-quality health systems. Global Policy, 8(S2), 5-6. https://doi.org/10.1111/1758-5899.12389
  • Wouters, Olivier J., McKee, Martin (2017). Private financing of health care in times of economic crisis: a review of the evidence. Global Policy, 8(S2), 23-29. https://doi.org/10.1111/1758-5899.12211
  • Wouters, Olivier J., Cylus, Jonathan, Yang, Wei, Thomson, Sarah, McKee, Martin (2016). Medical savings accounts: assessing their impact on efficiency, equity, and financial protection in health care. Health Economics, Policy and Law, 11(3), 321-335. https://doi.org/10.1017/S1744133116000025
  • Panteli, Dimitra, Arickx, Francis, Cleemput, Irina, Dedet, Guillaume, Eckhardt, Helene, Fogarty, Emer, Gerkens, Sophie, Henschke, Cornelia, Hislop, Jennifer & Jommi, Claudio et al (2016). Pharmaceutical regulation in 15 European countries: review. Health Systems in Transition, 18(5), 1-118.
  • Wouters, Olivier J., Naci, Huseyin, Samani, Nilesh J (2015). QALYs in cost-effectiveness analysis: an overview for cardiologists. Heart, 10(23), 1868-1873. https://doi.org/10.1136/heartjnl-2015-308255
  • Wouters, Olivier J., O'Donoghue, Donal J., Ritchie, James, Kanavos, Panos, Narva, Andrew S. (2015). Early chronic kidney disease: diagnosis, management and models of care. Nature Reviews Nephrology, 11(8), 491-502. https://doi.org/10.1038/nrneph.2015.85
  • Naci, Huseyin, Lehman, Richard, Wouters, Olivier J., Goldacre, Ben, Yudkin, John S (2015). Rethinking the appraisal and approval of drugs for type 2 diabetes. BMJ, 351(h5260). https://doi.org/10.1136/bmj.h5260
  • Wouters, Olivier J., Kanavos, Panos (2015). Transitioning to a national health system in Cyprus: a stakeholder analysis of pharmaceutical policy reform. Bulletin of the World Health Organization, 93(9), 606-613. https://doi.org/10.2471/BLT.14.148742
  • Chambers, James D., Naci, Huseyin, Wouters, Olivier J., Pyo, Junhee, Gunjal, Shalak, Kennedy, Ian R., Hoey, Mark G., Winn, Aaron, Neumann, Peter J. (2015). An assessment of the methodological quality of published network meta-analyses: a systematic review. PLOS ONE, 10(4). https://doi.org/10.1371/journal.pone.0121715
  • Wouters, Olivier J., Downs, Philip W., Zoerhoff, Kathryn L., Crowley, Kathryn R., Frawley, Hannah, Einberg, Jennifer, Chu, Brian K., Brady, Molly A., Oscar, Roland & Jeudi, Mireille et al (2014). Resource planning for Neglected Tropical Disease (NTD) Control Programs: feasibility study of the Tool for Integrated Planning and Costing (TIPAC). PLoS Neglected Tropical Diseases, 8(2), e2619. https://doi.org/10.1371/journal.pntd.0002619
    • Chapter
  • Cylus, Jonathan, Wouters, Olivier J., Kanavos, Panos (2015). Understanding the role of governance in the pharmaceutical sector: from laboratory to patient. In Greer, Scott, Wismar, Matthias, Figueras, Josep (Eds.), Strengthening Health System Governance: Better Policies, Stronger Performance (pp. 175-187). Open University.
  • Kanavos, Panos, Wouters, Olivier J. (2014). Pharmaceutical parallel trade: legal, policy, and economic issues. In Culyer, Anthony J. (Ed.), Encyclopedia of health economics (pp. 20-28). Elsevier (Firm).
    • Conference or Workshop Item
  • Kanavos, Panos, Wouters, Olivier J. (2014-02-27 - 2014-02-28) Concurrence dans la distribution de produits pharmaceutiques [Paper]. OECD Forum Mondial sur la Concurrence, Paris, France, FRA.
  • Kanavos, Panos, Wouters, Olivier J. (2014-02-27 - 2014-02-28) Competition issues in the distribution of pharmaceuticals [Paper]. OECD Global Forum on Competition, Paris, France, FRA.
    • Report
  • Laviolette, Luc, Gopalan, Sudararajan, Elder, Leslie, Wouters, Olivier J. (2016). Incentivizing nutrition: how to apply incentive mechanisms to accelerate improved nutrition outcomes: a practitioner’s compendium. World Bank.
  • Laviolette, Luc, Gopalan, Sudararajan, Elder, Leslie, Wouters, Olivier J. (2016). Incentivizing nutrition: incentive mechanisms to accelerate improved nutrition outcomes. World Bank.
  • Kanavos, Panos, Wouters, Olivier J. (2014). Pharmaceutical policies in Cyprus: a review of the current system and future options. World Health Organization.
    • Thesis
  • Wouters, Olivier (2018). Essays on prices, volumes, and policies in generic drug markets in high- and middle-income countries [Doctoral thesis]. London School of Economics and Political Science. https://doi.org/10.21953/lse.ppv5qzbr6y8s
    • Online resource
  • Wouters, Olivier J., Kanavos, Panos (2015). Primary health care should play bigger role in treating chronic kidney disease.
    • Blog post
  • Singh, Yashaswini, Reddy, Megha, Mehta, Neil K, Rooke-Ley, Hayden, Wouters, Olivier J., Fuse Brown, Erin C. (5 December 2025) Unpacking private equity investments in drug industry third-party entities. Health Affairs Forefront. https://doi.org/10.1377/forefront.20251203.568413
  • Hernandez, Inmaculada, Wouters, Olivier J., Cousin, Emma M., Kirihennedige, Ayuri S., Sullivan, Sean D. (3 September 2024) Interpreting the first round of maximum fair prices negotiated by Medicare for drugs. Health Affairs Forefront. https://doi.org/10.1377/forefront.20240830.863408
  • Wouters, Olivier J. (24 February 2021) Vaccine nationalism risks prolonging the global pandemic. LSE COVID-19 Blog. picture_as_pdf