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Price regulation and competition among on-patent anticancer drugs in Italy

Author

Listed:
  • Caimmi, Michele
  • Canali, Beatrice
  • Candelora, Laura
  • Di Costanzo, Alessandra
  • Fiorentino, Francesca
  • Vassallo, Chiara
  • Mancusi, Maria Luisa

Abstract

In recent years, the Italian Medicines Agency has adopted several measures aimed at curbing public pharmaceutical expenditure, including temporary and confidential price reductions, and Managed Entry Agreements. Besides, the Agency plays a pivotal role in price negotiations, serving as a tool for cost containment and financial sustainability for the Italian NHS. Our study aims at testing one potentially relevant channel for pursuing this objective and analyze if the Agency anchors the treatment cost of on-patent market entrants with those of on-patent therapeutic alternatives that previously obtained reimbursement in a given market. Our sample includes 86 anticancer indications which obtained reimbursement in Italy between March 2017 and May 2022, whose marketing authorization was granted under the centralized procedure at European level. Gathering data from multiple sources (drugs Summary of Product Characteristics, their pivotal clinical trials, and an IQVIA database on Italian negotiation dynamics), we identify competing indications within cancer site and treatment line, and then evaluate treatment costs based on median exposure to treatment in pivotal clinical trials. We retrieve prices from hospital expenditure data, which reflect discount negotiated with the regulator, tender, and commercial discounts. Our findings suggest that both the market average and the last reimbursed treatment cost significantly correlate with newly negotiated treatment costs, indicating that earlier negotiation outcomes serve as benchmarks for new ones.

Suggested Citation

  • Caimmi, Michele & Canali, Beatrice & Candelora, Laura & Di Costanzo, Alessandra & Fiorentino, Francesca & Vassallo, Chiara & Mancusi, Maria Luisa, 2025. "Price regulation and competition among on-patent anticancer drugs in Italy," Health Policy, Elsevier, vol. 157(C).
    • Handle: RePEc:eee:hepoli:v:157:y:2025:i:c:s0168851025001046
    DOI: 10.1016/j.healthpol.2025.105348
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    1. David H. Howard & Peter B. Bach & Ernst R. Berndt & Rena M. Conti, 2015. "Pricing in the Market for Anticancer Drugs," Journal of Economic Perspectives, American Economic Association, vol. 29(1), pages 139-162, Winter.
    2. Michael Schlander & Karla Hernandez-Villafuerte & Chih-Yuan Cheng & Jorge Mestre-Ferrandiz & Michael Baumann, 2021. "How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment," PharmacoEconomics, Springer, vol. 39(11), pages 1243-1269, November.
    3. Daniel Tobias Michaeli & Thomas Michaeli, 2024. "Launch and Post-Launch Prices of Injectable Cancer Drugs in the US: Clinical Benefit, Innovation, Epidemiology, and Competition," PharmacoEconomics, Springer, vol. 42(1), pages 117-131, January.
    4. Russo, Pierluigi & Carletto, Angelica & Németh, Gergely & Habl, Claudia, 2021. "Medicine price transparency and confidential managed-entry agreements in Europe: findings from the EURIPID survey," Health Policy, Elsevier, vol. 125(9), pages 1140-1145.
    5. Brekke, Kurt R. & Holmas, Tor Helge & Straume, Odd Rune, 2011. "Reference pricing, competition, and pharmaceutical expenditures: Theory and evidence from a natural experiment," Journal of Public Economics, Elsevier, vol. 95(7), pages 624-638.
    6. Ameet Sarpatwari & Jonathan DiBello & Marie Zakarian & Mehdi Najafzadeh & Aaron S Kesselheim, 2019. "Competition and price among brand-name drugs in the same class: A systematic review of the evidence," PLOS Medicine, Public Library of Science, vol. 16(7), pages 1-14, July.
    7. Granlund, David & Bergman, Mats A., 2018. "Price competition in pharmaceuticals – Evidence from 1303 Swedish markets," Journal of Health Economics, Elsevier, vol. 61(C), pages 1-12.
    8. Daniel Tobias Michaeli & Mackenzie Mills & Panos Kanavos, 2022. "Value and Price of Multi-indication Cancer Drugs in the USA, Germany, France, England, Canada, Australia, and Scotland," Applied Health Economics and Health Policy, Springer, vol. 20(5), pages 757-768, September.
    9. Pierluigi Russo & Matteo Zanuzzi & Angelica Carletto & Annalisa Sammarco & Federica Romano & Andrea Manca, 2023. "Role of Economic Evaluations on Pricing of Medicines Reimbursed by the Italian National Health Service," PharmacoEconomics, Springer, vol. 41(1), pages 107-117, January.
    10. Z. John Lu & William S. Comanor, 1998. "Strategic Pricing Of New Pharmaceuticals," The Review of Economics and Statistics, MIT Press, vol. 80(1), pages 108-118, February.
    11. Michaeli, Daniel Tobias & Mills, Mackenzie & Kanavos, Panos, 2022. "Value and price of multi-indication cancer drugs in the USA, Germany, France, England, Canada, Australia, and Scotland," LSE Research Online Documents on Economics 115720, London School of Economics and Political Science, LSE Library.
    12. Roediger, Alexander & Wilsdon, Tim & Haderi, Artes & Pendleton, Kathy & Azais, Boris, 2019. "Competition between on-patent medicines in Europe," Health Policy, Elsevier, vol. 123(7), pages 652-660.
    13. Charles Lindsey & Simon Sheather, 2010. "Variable selection in linear regression," Stata Journal, StataCorp LLC, vol. 10(4), pages 650-669, December.
    14. Simona Gamba & Paolo Pertile & Sabine Vogler, 2020. "The impact of managed entry agreements on pharmaceutical prices," Health Economics, John Wiley & Sons, Ltd., vol. 29(S1), pages 47-62, October.
    15. de Belvis, Antonio Giulio & Ferrè, Francesca & Specchia, Maria Lucia & Valerio, Luca & Fattore, Giovanni & Ricciardi, Walter, 2012. "The financial crisis in Italy: Implications for the healthcare sector," Health Policy, Elsevier, vol. 106(1), pages 10-16.
    16. Villa, Federico & Tutone, Michaela & Altamura, Gianluca & Antignani, Sara & Cangini, Agnese & Fortino, Ida & Melazzini, Mario & Trotta, Francesco & Tafuri, Giovanni & Jommi, Claudio, 2019. "Determinants of price negotiations for new drugs. The experience of the Italian Medicines Agency," Health Policy, Elsevier, vol. 123(6), pages 595-600.
    17. Danzon, Patricia M & Chao, Li-Wei, 2000. "Does Regulation Drive out Competition in Pharmaceutical Markets?," Journal of Law and Economics, University of Chicago Press, vol. 43(2), pages 311-357, October.
    18. Jean-Baptiste Trouiller & Philippe Laramée, 2023. "Comparative Assessment of Reimbursement Recommendations by NICE and HAS for Oncology New Medicines Indicated for the Treatment of Solid Tumors from 2015 to 2021," Medical Decision Making, , vol. 43(7-8), pages 961-972, October.
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