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Objective: The aim of this economic evaluation was to assess the cost-utility of brigatinib versus alectinib in the treatment of naïve patients to anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (ALK-positive aNSCLC) from the perspective of the Italian National Health Service (INHS). Methods: A partitioned survival model with four health states (progression-free [PFS], no central nervous system progression [CNS-PFS], central nervous system progression [CNS-PD] and death) was used. The clinical data (progression-free survival, overall survival and time to progression) was based on the ALTA-1L trial for brigatinib and on ALEX trial for alectinib. Utility values were derived from EORTC QLQ-C30 scores evaluated in the ALTA-1L trial and literature. Costs included frontline therapies, subsequent therapies, best supportive care (BSC), administration, concomitant medications, adverse events and health states. Direct medical costs and benefits (quality-adjusted life-years, QALYs) were discounted at a 3.0% annual rate. Uncertainty was assessed using deterministic (DSA) and probabilistic sensitivity analyses (PSA). Results: The analysis showed that brigatinib was dominant versus alectinib; brigatinib led to a gain of 0.216 QALYs and to a treatment cost reduction of € 85,635. The results of the DSA showed that no parameters of the model significantly modified the base case result. Conclusions: This economic evaluation suggested that, compared with alectinib, brigatinib can be considered a valid cost-utility option from the perspective of INHS in the treatment of patients with ALK-positive aNSCLC.

Background: Acromegaly is a rare, serious and disabling disease associated with increased mortality if not properly treated. The objective of this study was to estimate indirect and direct costs associated to uncontrolled acromegalic patients in Italy. Methods: a specific questionnaire was developed in order to obtain specific information from the patient perspective and administrated to subsequent patients treated in 17 Italian endocrinology centres. Indirect cost from patients and caregivers perspective were estimated considering the Human Capital Approach while direct cost were evaluated considering the patients perspective. assuming that our sample were representative of the general uncontrolled acromegalic patients. Results: 86 patients were enrolled in the study and complete the questionnaire. Of these 51.16% were employed, 23.26% were unemployed for reasons unrelated to the illness, 8,14% were unemployed due to the illness and 17.44% were inactive. The total costs per patient amounted to about € 3,832 per year, of which 5.1% are mobility costs, while the indirect costs come to € 7.7 million, of which 45.7% is due to illness-related to unemployment. Conclusions: To our knowledge, this study represents the first attempt to quantify the costs of uncontrolled acromegalic patients in Italy.

Francesco S Mennini,1,2 Raffaella Viti,1 Andrea Marcellusi,1–3 Paolo Sciattella,1 Ombretta Viapiana,4 Maurizio Rossini4 1Economic Evaluation and HTA (EEHTA), CEIS, Faculty of Economics, University of Rome “Tor Vergata”, Rome, Italy; 2Institute of Leadership and Management in Health, Kingston University, London, UK; 3Consiglio Nazionale delle Ricerche (CNR), Istituto di Richerche sulla Popolazione e le Politiche Sociali (IRPPS), Rome, Italy; 4Rheumatology Unit, Department of Medicine, University of Verona, Verona, Italy Background and aim: Spondyloarthritis (SpA) is a disease that normally affects the axial skeleton. It progressively leads to overall stiffness up to severe postural deformity of rachis and functional impotence. The objective of the study was to quantify, through an economic model, the impact of specialized testing and pharmacological treatments carried out by the National Health Service (NHS) in normal clinical practice, before the patient is diagnosed with SpA in Italy. In line with the analysis objective, the chosen perspective is that of the NHS.Method: The study was conducted by analyzing the Health Search Database – IMS Health Longitudinal Patient Database, from which newly diagnosed SpA patients were identified over the period 1 January 2007 to 31 December 2013. The use of specialist health care services and pharmacological treatments provided to the patients before the final SpA diagnosis were estimated.Results: Through a retrospective analysis of the Health Search Database, 1,084 subjects (aged 25–45 years) were identified. These patients produced an expense of approximately €153,000 in the 3 years prior to a confirmed SpA diagnosis, in terms of specialist check-ups and drugs, presumably not appropriately used due to a lack of diagnosis. If we assume that the Health Search Database is a representative sample of the Italian population, it may be estimated that, in the 3 years p

The pharmaceutical sector is characterized by the level of investments required in response to the growing challenges in terms of demand for health. In most European countries the pharmaceutical industry, through production, research, intermediate goods and wages, contributes to GDP for a value of about 1%. The impact of the pharmaceutical industry on the added value varies from 23 billion euro in Switzerland to 9.6 billion euro in Spain; for Italy, this value is about 14 billion euro, higher than the average of other European countries. However, despite these positive findings, Italy can hardly keep up with other European countries in investments in R&D in the pharmaceutical sector. An even larger amount of resources is required by the development of personalized therapies and new generation drugs, e.g. developed through biotechnology, which are more effective in responding to complex health needs. Clear rules, aimed at defining and fostering innovation, together with competitive pricing models, are required to attract investments in the pharmaceutical sector. There are other aspects to be considered for an overall assessment of the pharmaceutical sector: among these, there are drug prices, logistic costs, limitations to pharmaceutical spending, the latter introduced by the law no. 222/2007. The indiscriminate cuts in pharmaceutical spending are likely to destabilize the health system, since they pose a risk to the health of the population. Reforms over time should be designed to trigger the virtuous cycle innovation-development-patient protection.

Introduction The hepatitis C virus (HCV) induces several pathological conditions with a substantial medical and economic burden. Currently licensed treatments for HCV infection include pegylated and standard interferon alpha (IFN), ribavirin (RBV), the protease inhibitors boceprevir, telaprevir, and boceprevir. A new scenario of therapy for HCV infection is being established following new treatments approval. The aim of this study is to evaluate new strategies long-term health outcomes and the willingness to pay for new anti-HCV treatments from the Italian societal perspective. Methods A multistate morbidity-mortality model was developed to estimate the infection progression in a theoretical cohort of Italian subjects. The Markov model considered 12 health states (F0, F1, F2, F3, Compensated cirrhosis (F4), SVR, decompensated cirrhosis, HCC, Transplantation (1 year), Transplantation (years later), HCV-related death and death from other causes) and 42 transition probabilities. The model was fed with data from national and international literature. The effectiveness of the new treatment strategies was hypothesized taking into account a literature review of clinical trials of innovative drugs that in the near future will be available in Italy. Estimates were also obtained for the cumulative number of HCV-related disease cases and the direct and indirect medical costs that will be avoided because of the increased effectiveness of new treatments. Results The cohort of subjects with chronic HCV in 2013 contained 267,190 subjects; of these about 17,600 patients F3-F4 are treated with drug therapy. The model predicted that the cumulative cases of HCV-related diseases prevented because of the larger effectiveness of the new treatments amounted to 47,433 after 7 years, 156,507 after 17 years, 256,942 after 27 years. The direct net medical costs, excluding the drug cost, amounted to € 18.13, € 72.33 and € 143.24 millions after 7, 17 and 27 years respectively, plus € 166.51, €