title: Do the current performance-based schemes in Italy really work? "Success fee": a novel measure for cost-containment of drug expenditure.
abstract: BACKGROUND
  Drug costs have risen rapidly in the last decade, driving third-party payers to adopt performance-based agreements that provide either a discount before payment or an ex post reimbursement on the basis of treatments' effectiveness and/or safety issues.
  
  
  OBJECTIVE
  This article analyses the strategies currently approved in Italy and proposes a novel model called "success fee" to improve payment-by-result schemes and to guarantee patients rapid access to novel therapies.
  
  
  METHODS
  A review of the existing risk-sharing schemes in Italy has been performed, and data provided by the Italian National report (2012) on drug use have been analyzed to assess the impact on drug expenditure deriving from the application of "traditional" performance-based strategies since their introduction in 2006.
  
  
  RESULTS
  Such schemes have poorly contributed to the fulfillment of the purpose in Italy, producing a trifling refund, compared with relevant drugs costs for the National Health System : €121 million out of a total of €3696 million paid. The novel risk-sharing agreement called "success fee" has been adopted for a new high-cost therapy approved for idiopathic pulmonary fibrosis, pirfenidone, and consists of an ex post payment made by the National Health System to the manufacturer for those patients who received a real benefit from treatment.
  
  
  CONCLUSIONS
  "Success fee" represents an effective strategy to promote value-based pricing, making available to patients a rapid access to innovative and expensive therapies, with an affordable impact on drug expenditure and, simultaneously, ensuring third-party payers to share with manufacturers the risk deriving from uncertain safety and effectiveness.
authors.affiliation: Department of Biomedical and Biotechnological Sciences, University of Catania, University of Catania, Catania, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Navarria
authors.affiliation: Department of Pharmaceutical Sciences, University of Eastern Piedmont, Alessandria, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Drago
authors.affiliation: Department of Biomedical and Biotechnological Sciences, University of Catania, University of Catania, Catania, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Gozzo
authors.affiliation: A.O.U. Policlinico - Vittorio Emanuele, Catania, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Longo
authors.affiliation: A.O.U. Policlinico - Vittorio Emanuele, Catania, Italy.
authors.forename: Silvana
authors.initials: S
authors.lastname: Mansueto
authors.affiliation: Department of Economics and Quantitative Methods, University of Catania, Catania, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Pignataro
authors.affiliation: Department of Biomedical and Biotechnological Sciences, University of Catania, University of Catania, Catania, Italy. Electronic address: f.drago@unict.it.
authors.forename: Filippo
authors.initials: F
authors.lastname: Drago
mesh_terms: D003363:Cost Control / Q000191:economics / Q000639:trends; D016527:Drug Costs / Q000639:trends; D005102:Health Expenditures / Q000639:trends; D006801:Humans; D007558:Italy; D012052:Reimbursement, Incentive / Q000191:economics* / Q000639:trends
keywords: cost-containment; performance-based; reimbursement; risk-sharing