1. ABSTRACT - http://www.cermlab.it/argomenti.php?group=farmaceutico&item=99
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 over
Gdp can double or more than double in all industrialized countries by 2060. Recent trends in
resources absorbed by new oncological drugs can already give a proof of the unprecedented impact
R&D and technology could have on expenditure for health during next years. National systems
should prepare to face this challenge putting in place an appropriate regulatory framework, capable
of balancing and harmonizing the two goals of financial sustainability and adequacy in the access. If
we consider the case of Italy, this framework remains still seriously incomplete, and a clear example
of the deficit of governance arrives again from pharmaceuticals and especially from oncological
drugs. Regulation is fragmented between State, Regions and Hospitals. The national list of
reimbursable drugs can be restricted by Regions and even by Hospitals and used as a tool to control
expenditure in an administrative manner. The counterparty of this rudimental governance is that not
all drugs are available to citizens resident in different Regions and even resident in different areas of
the same Region. In front of this discrimination it is also possible to recognize violations of
constitutional principles. Unjustified differences can be underlined also with regard to instruments
and practices used to monitor therapies based on oncological products or, more in general, to monitor
the use of high cost pharmaceuticals. There is the obligation to register oncological therapies, before
starting 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 remain
widely diversified and scarcely opened to adopt best practices. The so called “F file”, the electronic
device on which each Hospital takes trace of the use of oncological / high cost drugs, can show
different structure even in the same Region. For this reason, the “F file” cannot work as a
standardized instrument to transmit to Aifa data about the evolution of the therapies, although this
would clearly be the optimal solution. But differences do not stop here: some Hospitals have the habit
to register in the file “F” all oncological / high cost drugs; in other cases, the registration depends
upon characteristics like the way of providing (oral, parenteral, with injection), the regime of
hospitalization (ordinary in-patient, day-hospital, domiciliary assistance), and the Region of residence
of the assisted (of the same Region as the Hospital or of a different Region). In some cases the cost of
the drug is comprised in the DRG tariff of the therapy; in other case, the drug is given a specific
separated cost, at the same time abating the DRG tariff of percentages varying from case to case. Not
to take into account differences in copayment schemes. There is a clear and urgent need for a
simplification and an homogenization of instruments and rules across Hospitals end Regions. In
particular: drugs admitted by Aifa at the national level should become available as soon as possible in
every Hospital of every Region; instruments to monitor and report the use of high cost drugs should
be fully homogenized (in order to have understandable and aggregable data, available also for HTA
evaluations); expenditure control should become transparent and decided on the basis of explicit
political choices, that means with a systematic recourse to the selection of beneficiaries with respect to
positive relevant characteristics, as well as with implementation of copayment schemes coordinated
within Regions.
Link -> http://www.cermlab.it/argomenti.php?group=farmaceutico&item=99