title: Free drugs in clinical trials and their potential cost saving impact on the National Health Service: a retrospective cost analysis in Italy.
abstract: BACKGROUND
  The cost of new anti-cancer drugs has dramatically increased in recent years, and countermeasures are required in order to limit pharmaceutical expenses. Sponsored clinical trials that provide drugs free of charge may be a useful tool in order to reduce drug costs. The aim of this analysis is to evaluate the effect of clinical trials on pharmaceutical expenditure savings.
  
  
  METHODS
  We evaluated the cost of drugs administered in clinical practice and in clinical trials (considering only the standard regimens that were administered also in clinical practice) in 2010 at the Lung Cancer Unit of the National Institute for Cancer Research in Genoa, Italy. The cost of drugs was calculated on the price charged at our Institute in 2010. The supposed cost of experimental treatment replacing standard therapy was converted in the cost of the treatments that would have been chosen in clinical practice, considering histology, line of treatment and number of administered cycles.
  
  
  RESULTS
  From 1/1/2010 to 12/31/2010, 196 patients affected by lung cancer or pleural mesothelioma were treated. 152 patients (78%) received treatment in clinical practice or in non-sponsored trials (18 patients in 4 trials), while 44 (22%) were treated in one of the 12 sponsored clinical trials recruiting in 2010. Globally, 606 cycles of treatment would have been administered to patients, of which 436 (72%) were administered in clinical practice or in non-sponsored trials and 170 (28%) were administered in pharmaceutical company sponsored clinical trials. The overall cost of those anti-neoplastic drugs, based on the prices charged at our Institute in 2010, was €799 803. The cost of drugs administered in clinical practice or in non-sponsored trials was €556 649 (70%), whereas the cost of standard drugs administered in clinical trials was €243 154 (30%). The grants provided by pharmaceutical companies were evaluated and amounted to €235 965.
  
  
  CONCLUSIONS
  The participation in sponsored clinical trials in which drugs are provided free of charge offers substantial cost savings for the National Health Service; moreover, the grants received for each enrolled patient produced additional income.
authors: IRCCS Azienda Ospedaliera Universitaria San Martino IST - Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy. francesco.grossi@istge.it
authors: Francesco
authors: F
authors: Grossi
authors: Carlo
authors: C
authors: Genova
authors: Nidia Diaz
authors: ND
authors: Gaitan
authors: Maria Giovanna
authors: MG
authors: Dal Bello
authors: Erika
authors: E
authors: Rijavec
authors: Giulia
authors: G
authors: Barletta
authors: Claudio
authors: C
authors: Sini
authors: Caterina
authors: C
authors: Donato
authors: Sabrina
authors: S
authors: Beltramini
authors: Paolo
authors: P
authors: Pronzato
authors: Gianfranco
authors: G
authors: Porcile
authors: Francesco
authors: F
authors: Boccardo
authors: Stefan
authors: S
authors: Walzer
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000191:economics*; D017046:Cost Savings / Q000191:economics; D003362:Cost-Benefit Analysis / Q000191:economics; D003365:Costs and Cost Analysis / Q000191:economics; D006801:Humans; D007558:Italy; D009313:National Health Programs / Q000191:economics*; D009369:Neoplasms / Q000188:drug therapy* / Q000191:economics*; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents
keywords: Clinical trials; Cost savings; Drugs expenditure; Mesothelioma; NSCLC; SCLC