AIFA has developed a wide range of approaches to control the impact of new products and indications. Management entry agreements focus on managing the following: (1) the impact of new drugs on the budget; (2) uncertainty about the clinical efficacy or cost-effectiveness of a drug in a real-world environment; and (3) control of drug use for optimal performance, by targeted patients or by the use of delivery mechanisms. The instruments used by AIFA during the pricing and refund process are presented in Figure 1. As expected, CS agreements appear to be more effective than RS and PbR for revenue testing ; A system based on a simple rebate should be much easier to manage than a system that relates to clinical outcomes that involve a default evaluation date, often difficult to determine . Abstract: Conditional reimbursement systems between pharmaceutical companies and buyers have been set up by the Italian Medicines Agency (AIFA). This article provides an overview of the goals of AIFA`s “manacity entry program,” approaches and tools developed to achieve its goals. van de Vooren, K., Curto, A., Freemantle, N., and Garattini, L. (2015). Market access agreements for cancer drugs. J. R. Soc.
Med. 108, 166-170. doi: 10.1177/0141076814559626 Ferrario, A., and Kanavos, P. (2015). Management of uncertainty and high prices for new medicines: a comparative analysis of the use of market entry agreements administered in Belgium, England, the Netherlands and Sweden. Soc. Sci. Med.
124, 39-47. doi: 10.1016/j.socscimed.2014.11.003 The development of these instruments continues to grow at European level. AIFA is actively involved in a project funded by the European Commission on behalf of the Italian National Health Service (NHS) entitled “Capacity building on managed entry agreements for innovative medicines”. 19 European countries are participating in the project. All countries agree that controlled accession agreements are valuable in balancing access to medicines with rising costs. Management entry agreements can play a key role in accessing drugs when uncertainties are related to the therapeutic benefits of drugs or when the cost of new drugs is high. To our knowledge, no published report contains clinical data on drugs submitted to the RS/PbR agreements and, in general, in the AIFA registries, with the exception of a summary report very early in 2007 . If one reviews the forms relating to the clinical status of patients (all available on the AIFA website) , it is clear that they accurately reflect the indication of marketing authorization and require little additional information useful for an advanced clinical evaluation. Therefore, it is unlikely that the information collected will contribute to existing drug evidence under these agreements, beyond the self-certified validation of an appropriate prescription by the prescribers. Keywords: Cancer, Managed Entry Agreements, Risk Sharing, Garattini Repayment, L., Casadei, G.: Risk Sharing Agreements: What Lessons from Italy? Int. J.
Technol. Evaluation. Health Care 27, 169-172 (2011) Italy is one of the countries that started these agreements very early: the Italian Drug Agency (AIFA) agreed on its first treaty in July 2006 . The complex management of these systems, now referred to by AIFA as Managed Entry Agreements (MMA) and similar to patient access systems in the UK, is entirely based on web registries.