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Abstract Report Oncology


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Abstract Report Oncology

  1. 1. ABSTRACT - GOVERNANCE OF THE EXPENDITURE IN ONCOLOGICAL DRUGS IN ITALY Pammolli F. (CeRM) Riccaboni M. (CeRM) Salerno N. C. (CeRM)Long term projections (Oecd, Imf, Ecofin) show that the incidence of health care expenditure overGdp can double or more than double in all industrialized countries by 2060. Recent trends inresources absorbed by new oncological drugs can already give a proof of the unprecedented impactR&D and technology could have on expenditure for health during next years. National systemsshould prepare to face this challenge putting in place an appropriate regulatory framework, capableof balancing and harmonizing the two goals of financial sustainability and adequacy in the access. Ifwe consider the case of Italy, this framework remains still seriously incomplete, and a clear exampleof the deficit of governance arrives again from pharmaceuticals and especially from oncologicaldrugs. Regulation is fragmented between State, Regions and Hospitals. The national list ofreimbursable drugs can be restricted by Regions and even by Hospitals and used as a tool to controlexpenditure in an administrative manner. The counterparty of this rudimental governance is that notall drugs are available to citizens resident in different Regions and even resident in different areas ofthe same Region. In front of this discrimination it is also possible to recognize violations ofconstitutional principles. Unjustified differences can be underlined also with regard to instrumentsand practices used to monitor therapies based on oncological products or, more in general, to monitorthe use of high cost pharmaceuticals. There is the obligation to register oncological therapies, beforestarting them, in a central database managed by Aifa (the Italian Agency for Pharmaceuticals). This is,anyway, the only governance step fully shared by Hospitals. Internal monitoring procedures remainwidely diversified and scarcely opened to adopt best practices. The so called “F file”, the electronicdevice on which each Hospital takes trace of the use of oncological / high cost drugs, can showdifferent structure even in the same Region. For this reason, the “F file” cannot work as astandardized instrument to transmit to Aifa data about the evolution of the therapies, although thiswould clearly be the optimal solution. But differences do not stop here: some Hospitals have the habitto register in the file “F” all oncological / high cost drugs; in other cases, the registration dependsupon characteristics like the way of providing (oral, parenteral, with injection), the regime ofhospitalization (ordinary in-patient, day-hospital, domiciliary assistance), and the Region of residenceof the assisted (of the same Region as the Hospital or of a different Region). In some cases the cost ofthe drug is comprised in the DRG tariff of the therapy; in other case, the drug is given a specificseparated cost, at the same time abating the DRG tariff of percentages varying from case to case. Notto take into account differences in copayment schemes. There is a clear and urgent need for asimplification and an homogenization of instruments and rules across Hospitals end Regions. Inparticular: drugs admitted by Aifa at the national level should become available as soon as possible inevery Hospital of every Region; instruments to monitor and report the use of high cost drugs shouldbe fully homogenized (in order to have understandable and aggregable data, available also for HTAevaluations); expenditure control should become transparent and decided on the basis of explicitpolitical choices, that means with a systematic recourse to the selection of beneficiaries with respect topositive relevant characteristics, as well as with implementation of copayment schemes coordinatedwithin Regions.Link ->