Regional tenders on biosimilars in Italy: potentially competitive?
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 3
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.
Authors and Affiliations
Alessandro Curto, Katelijne Van de Vooren, Roberta Lo Muto, Silvy Duranti, Livio Garattini
Ongoing initiatives in the Republic of Srpska to enhance prescribing efficiency; influence and future directions
Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products and measures to obtain low...
Common or distinct INN for biosimilars? Only characteristics of the active substance prior to formulation should be considered
To the Editor: I read with interest the letter of Dr Edward T Maggio which was published in Volume 2/Year 2013/Issue 4 of the Generics and Biosimilars Initiative Journal [1] on the naming issue for biosimilars and trace...
WHO leadership in public safety on biosimilars to be commended
As a practicing endocrinologist and Chairman of the Alliance for Safe Biologic Medicines, I am writing to commend the World Health Organization for its attention to and upcoming action on the important issue of non-propr...
Top developments in biosimilars during 2013
The past year has been a busy one for the biosimilars industry. Perhaps one of the most important milestones during 2013 was the European approval of the first monoclonal antibody biosimilar [Remsima/Inflectra (inflixima...
The potential of generics policies: more room for exploitation–PPRI Conference Report
Introduction: This Conference Report aims to provide an overview of key results, messages and conclusions of the Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference with regard to generics. Methods: Th...