The economic impact of biosimilars in Italy: a scenario analysis

Authors

  • Francesco S Mennini Institute for Leadership and Management in Health - Kingston University London, London, UK
  • Andrea Marcellusi Institute for Leadership and Management in Health - Kingston University London, London, UK
  • Chiara Bini Economic Evaluation and HTA (EEHTA), CEIS, Faculty of Economics, University of Rome Tor Vergata, Rome, Italy
  • Maria Assunta Rotundo Economic Evaluation and HTA (EEHTA), CEIS, Faculty of Economics, University of Rome Tor Vergata, Rome, Italy
  • Alessandro Giunta Department of Dermatology, University of Rome Tor Vergata, Rome, Italy
  • Antonio Gasbarrini Department of Internal Medicine, A. Gemelli Teaching Hospital, Catholic University of the Sacred Heart, Rome, Italy
  • Guido Valesini Department of Internal Medicine and Medical Specialities, Sapienza University of Rome, Rome, Italy
  • Pier Luigi Canonico Dipartimento di Pharmaceutical Sciences, Università degli Studi del Piemonte Orientale Amedeo Avogadro
  • Ettore Novellino Director of CIRFF (Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione), University of Naples Federico II, Naples, Italy
  • Valentina Orlando Director of CIRFF (Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione), University of Naples Federico II, Naples, Italy
  • Alessandra Mecozzi Director Pharmaceutical Assistance, ASL (Local Health Authorty) Latina, Latina, Italy
  • Teresa Gamucci Oncology Unit, Sandro Pertini Hospital, Rome, Italy
  • Livio Pagano Hematology Institute – Polo di Onco-Ematologia, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
  • Eugenio Di Brino Alta Scuola di Economia e Management dei Sistemi Sanitari (ALTEMS), Università Cattolica del Sacro Cuore, Rome, Italy
  • Matteo Ruggeri Alta Scuola di Economia e Management dei Sistemi Sanitari (ALTEMS), Università Cattolica del Sacro Cuore, Rome, Italy
  • Americo Cicchetti Alta Scuola di Economia e Management dei Sistemi Sanitari (ALTEMS), Università Cattolica del Sacro Cuore, Rome, Italy

DOI:

https://doi.org/10.33393/grhta.2019.457

Keywords:

Biosimilari, costi, anti-TNF

Abstract

Background: the first generation of biotechnology drugs is reaching, or has already reached, the patent expiry and a large number of biosimilars is entering the Italian pharmaceutical market. The objective of the analysis was to evaluate the economic impacts of biosimilars on the national health expenditure in Italy between 2014 and 2020. Methods: Based on the information deriving from consumption per standard unit and equivalent patients, it was estimated monthly expenditure for some of the biological drugs currently available in Italy that have had or will have a patent expiry within the analysis period (infliximab, etanercept, adalimumab, insulin glargine, trastuzumab, rituximab, bevacizumab and insulin aspart). Pharmaceutical expenditure was calculated on hospital sales prices net of transparent discounts required by law and visible from the AIFA database. Three alternative scenarios have been developed based on the perceptions of a board of clinical experts, pharmacologists and pharmacoeconomists involved in the study. The experts involved analyzed the estimates of treated patients between 2014 and 2017 and reports their hypothetical biosimilar penetration during the period 2018-2020. The results were represented as the difference between the estimated expenditure in the absence of biosimilars and the estimated expenditure in the presence of biosimilars with the real or hypothetical biosimilar penetration. Results: considering the standard units dispensed for each year, the economic model estimate an annual expenditure in 2014 equal to € 1.47 billion for the molecules considered in the analysis. These estimates rise to € 1.54, € 1.50 billion and € 1.51 billion during 2015, 2016 and 2017 in the scenario without biosimilar introduction. Biosimilar introduction generates cost savings between € 3.8 million in 2015 and € 32.9 million in 2017 if compared with the scenario without. Assuming an increasing biosimilar penetration between 2018 and 2020, scenario analysis estimates a cumulative cost reduction equal to € 597 million. Conclusions: Overall, biosimilar penetration generates important cost reduction that could be re-invested in the National Health Sistem.