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
Keywords
Related Articles
- EP ID EP354885
- DOI 10.5639/gabij.2013.0203.036
- Views 137
- Downloads 0
What to look forward to in GaBI Journal, 2012, issue 2
It is my pleasure to introduce the second edition of GaBI Journalwhich contains a number of interesting articles. Professors Benjamin and Kearns present a review of advances in paediatric drug development and labelling,...
Alleviating concerns around generic antiepileptic medications
Epilepsy features the unpredictable onset of seizures that can be devastating to a patient’s quality of life. Fortunately there are medications available to control the onset of seizures. But because these have to be tak...
Recent trends and special topics in new drug review in PMDA
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory agency, which works together with the Ministry of Health, Labour and Welfare. At the 24th Drug Information Association Annual EuroMeeting in Mar...
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...
Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care
Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care Oncologists have been urged to embrace biosimilar drug substitution to help control the spiralling costs of cancer care. However, t...