Regional tenders on biosimilars in Italy: potentially competitive?

Abstract

Introduction: Health care in Italy is mainly delivered through the country's National Health Service (NHS), a public service funded by general taxation. The system is highly decentralized and each one of the 20 Regional Health Authorities (RHAs) can establish a central organization for purchasing goods and services. Drugs are purchased via a tender process, which is similar to an auction; price quotations are invited from drug manufacturers before a decision is made on the preferred manufacturer. There are three off - patent biologicals (somatropin, epoetin, filgrastim) for which biosimilars are already available in Italy. Here we present and analyse the various regional tenders referring to the three off - patent biologicals, in order to assess the potential level of competition. Methods: To collect detailed information, we conducted a web- based analysis up to December 2012. Only eight RHAs have held tenders that include biosimilars. We analysed the main characteristics of these tenders, focusing in particular on the base quantities and base prices reported in the bids for each lot including one of the three off - patent biologicals considered. We then estimated the number of potential competitors for each. Results: From the 24 tenders analysed, we retrieved 191 lots referring to the three off - patent biologicals. The prevailing practice in Italy is to launch very large tenders split into many lots. The need to continue a therapy that had already started, according to the current non-substitution policy, might explain the substantial number of lots restricted to original agents (around 30%). Nevertheless, the lack of potential competition, particularly for somatropin seems to be extensive and hard to justify. Conclusion: In theory, the economic literature suggests that worthwhile savings can be achieved from public tenders. However, in practice this depends on how the bidders (manufacturers) and buyers (regional authorities) behave in the market.