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The availability of new drugs potentially able to drastically reduce the burden of very common infectious diseases like hepatitis C requires the national health services to take a different decision-making process. On the one hand, there is an evident financial issue; on the other hand, low budgets may undermine a system that provides universal access to healthcare. It is unrealistic to expect retrieving the financial resources needed from negotiating prices with pharmaceutical companies, resource reallocation or a reduction in economic waste. The national health systems need a new priority setting and a National fund for healthcare innovation should be built. Novel drugs should be evaluated balancing availability and opportunity, forcing to rethink the decision-making processes. Macro- (re-prioritization of interventions) and micro-policies (the introduction of financial aspects in the process of pricing) are needed, trying to combine welfare and industrial policies.

Background and Objectives: Biologic therapies are considered to be cost effective by leading Health Technology Assessment (HTA) agencies and, therefore, eligible for reimbursement by public health services. However, biologic therapies entail sizable incremental costs and, besides, have a considerable financial impact that in Italy amounts to 13.7 % of the national health service's pharmaceutical expenditure. In the reimbursability decision process, an important role is played by both the drug efficacy data observed in pre-licensing RCTs and the economic modelling assumptions, as they give evidence on cost effectiveness. The administration of therapies in real practice settings is likely to produce a significant deviation from the results predicted by the models, theoretically outweighing the assumption on which the decision process is founded. This is a matter of concern for public health services and, consequently, an interesting topic to investigate., Methods: To overcome the lack of knowledge concerning the actual cost effectiveness of biologic therapies for the treatment of plaque psoriasis in the clinical practice setting in Italy, an observational study was conducted in 12 specialist centres on patients switching to biologic therapy within a 6-month enrolment window., Results: The study confirms in clinical practice the efficacy of the switch to biologic therapies, analysed using a number of clinical [Psoriasis Area and Severity Index (PASI), pain visual analogue scale (VAS) and itching VAS] and quality-of-life parameters. A general health-related quality of life (HR-QOL) improvement, with a 0.23 quality-adjusted life-year (QALY) mean gain per patient, has been reported in the 6-month observation period. The direct medical costs to treat plaque psoriasis with biologic therapies amount to 15,073.7 per year (prior to their enrolment, the same patients cost 2,166.2 on an annual basis). After the switch to biologic agents, the cost per QALY during the first year of treatment amounts to 28,656.3., Conclusion: At least in the short-term, the clinical practice of the specialised Italian centres taking part in the study confirms that switching patients to a biologic drug produces an incremental cost-effectiveness ratio comparable with the values predicted by the HTA bodies.

Background. The aim of this study was to analyze the formalization of hospital pathways for patients with acute heart failure (AHF) and to describe standards of accreditation and funding of the providers. Methods. This study was carried out in 10 Italian Regions, through the analysis of regional determination and grey literature. Results. Pathway standardization is mainly present for patients with chronic heart failure; only the Piedmont and Emilia Romagna Regions provide a formal standardization for patients with AHF. Among the analyzed Regions, there were no differences in the start of the management process for AHF, including hospital admission. Conversely, several differences were observed among Regions in the organization of Short Way Observation (both in terms of duration and supply), the possibility of alternative modality of admission (e.g. "home hospitalization") and the funding rules of emergency departments. Conclusions. These above stressed differences are likely to have a significant impact on the optimal management of patients with AHF.

Background. Acute heart failure (AHF) is a common and clinically relevant condition that usually implies the need for hospitalization. The aim of this study was to provide data about hospital activity related to AHF at a national and regional level. Methods. The analysis describes acute hospitalization (year 2010) for AHF in both public and private accredited facilities in the Italian Regions and Autonomous Provinces, using as source the hospital discharge records collected by the Italian Ministry of Health. Results. Our findings are consistent with available data in the literature, although they show relevant outcome variability regarding hospitalization rates and mean length of hospital stay. Conclusions. Evaluation of hospitalization costs confirms that the burden of hospitalization is quite high, though characterized by a great variability.

Aim: Psoriasis is a common, chronic, immune-mediated skin disorder that may be complicated by psoriatic arthritis in up to one-third of patients. Psoriasis treatments are increasingly effective, yet more expensive, thus requiring rational decision-making on interventional priorities. The ability to perform cost-utility analyses is hindered by the lack of algorithms that allow the inference of utility measures, like QALY, from specific dermatological health-related quality-of-life (HR-QoL) measures (e.g. Dermatology Life Quality Index [DLQI]). This study aimed to assess whether psoriasis-related HR-QoL data (DLQI) could be used to obtain utility measures for use in economic analyses., Methods: Psoriasis patients attending 11 Italian Psocare project treatment centers over a 19-day period were enrolled and completed a questionnaire, including several HR-QoL scales and sociodemographic/clinical data, and underwent a clinical examination. Data were subjected to a Multiple Correspondence Analysis and multiple regression analysis to determine the contribution of single items to the HR-QoL., Results: DLQI and Psychological General Well-Being Index (PGWBI) scores were most closely correlated with the EuroQol health status index. Age and gender were considered confounding factors, while pain and arthritis contributed significantly to HR-QoL deterioration. For disease severity, the need for hospitalization and the number of examinations, but not the Psoriasis Area Severity Index (PASI), contributed to HR-QoL deterioration., Conclusion: Recent historical clinical and HR-QoL data from psoriasis patients can reproducibly define a health status index, such as the EuroQol SD-5Q, that could be used reliably to estimate QALYs for use in cost-utility analyses to compare the cost-benefit profiles of competing therapies.

In most Italian hospitals, sanitary reform is being applied, while at the same time a new organization of the National Health System is being planned. The director of the medical hospital (head doctor) is becoming more and more involved in management and this aspect has modified his professional attributes. Cardiology is a branch of medicine that, through its scientific preparatory work consisting in debates, management courses, ethics, and production of managerial software, is closer to applying the reform without risking improper administrative aspects. This, obviously, comes about after thoroughly reviewing past work methods and the need to have an administrative organization, which allocates efficient use of manpower and materials, helping to eliminate any sources of inefficiency. The logical procedure foresees an actual analysis in terms of sanitary needs and availability of resources, and so attempting to better balance and harmonize both aspects of the problem. Certainly, the acquisition of theoretical norms and practices, which today are present because of the upsurge in training courses for doctors, is not enough to guarantee the achievement of optimal results. Furthermore, we find that theoretical models need to be validated and adapted to real work situations in the public hospital sector. This paper proposes, therefore, to explain the managerial experiences achieved in actual work situations at the Cardiology Department Unit of the San Giovanni Addolorata Hospital in Rome. In particular, it shows that in order to reach its clinical and economical objectives, it is essential to make available correct informative support for strategic and operational decisions. We can observe that there is a continuing lack of computer support systems being integrated into the present organization of most cardiology units. The use of software distributed to cardiology units from the Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO) has enabled us to partially remedy the above-mentioned inadequacy and, at the same time, has pointed out the limits of automated support with regards managerial needs which are rapidly changing and becoming increasingly more complex. The experience described shows the possibility of uniting an efficient organization, from a clinical point of view, with an adequate managerial automation without including any flaws from the previous organizational systems. Based on achieved results and the difficulties encountered, further development in computer technology support to hospital management is suggested. This paper, in particular, stresses the need to improve automated informative support available to doctors in managerial positions. This improvement would allow us to immediately evaluate "internal" administrative matters, have the data available for budget planning and analysis of budget variations, and be better able to integrate this with clinical data. The scientific community can give further assistance by promoting the genesis of data for a sensible bench-marking within medical organizations which is the only means sufficient to give reliable and clinically appropriate indications on the possibility of increasing its own structural efficiency.