Abstract: Background National Health Service has always played a key role in the economic growth of a Country. For this reason it undergoes a continuous change trying to find a balance between available resources and appropriateness of care. Objective The aim of this work was to develop a quantitative model which simulates the intra-regional health mobility in order to obtain an overall improvement in the quality of the service offered. Methods For this study we used two quantitative tools derived from spatial geography and operational research, which represent patient flow within a geographical area by studying the interactions between demand and supply of health services. Results The model allowed us to conduct several simulations in order to test the response of the local health system in the following cases: analysis of workload interactions between supply and demand with a fixed allocation of resources and assuming an increase in demand of 20–30%; planning availability of beds, in order to find a minimum solution for ICU and CCU; find the optimal number of hospital beds, to improve accessibility to Obstetrics and Gynaecology department with a stable supply of care. Conclusions Though evaluation of intra-regional health mobility is quite complicated, use of quantitative methods, like gravity models and location-allocation models, gives to policy makers a set of useful information to define regional health policy. PubDate: 2013-11-09
Abstract: Background The treatment of chronic inflammatory bowel disease (IBD) is always a challenge for gastroenterologists dealing with this type of condition. The development of granulocyte-monocyte apheresis (GMA) appears to be an innovative approach, comprising both treatment safety and therapeutic potential. Objective To assess the cost-consequence of granulocyte monocyte adsorption—apheresis (GMA-Apheresis; Adacolumn®) versus infliximab in the treatment of moderate-to-severe ulcerative colitis (UC) in steroid-dependent or steroid-resistant patients. Methods One-year cost-consequence analysis from the Italian National Health Service (NHS) perspective using a decision tree model was carried out. Probabilities of each event were derived from literature and an expert panel. Direct medical costs were obtained from official sources (€2013). Results The average annual cost per patient who started the treatment with GMA-Apheresis was estimated to be €13,931.33; the cost was estimated to be €15,179.08, starting the treatment with infliximab. The sensitivity analysis confirmed the results of the base case. Conclusions We performed a cost-consequence analysis focused on the use of GMA-Apheresis (Adacolumn®) in the therapeutic management of moderate-to-severe UC in steroid-dependent or steroid-resistant patients. From the Italian NHS perspective, GMA-Apheresis is a cost-saving strategy compared with infliximab. PubDate: 2013-08-30
Abstract: Background Stroke is the most frequent cause of acquired spastic paresis. Different studies have indicate that intramuscular injection of botulinum toxin A is an effective means of alleviating spasticity in stroke patients. Objective We estimated the cost (cost minimization analysis, CMA) of two treatment strategies for spasticity following a stroke: physiotherapy only and botulinum toxin A plus physiotherapy. Methods The sequence of medical interventions and health states in chronic spasticity following stroke was developed based on a Delphi Panel survey. The economic parameters were derived from direct medical costs incurred by the Italian National Health Service (NHS). The clinical parameters (severity of spasticity) were derived from a previous cost-effectiveness analysis. Results The mean cost of treatment was €7,376.57 for patient treated with botulinum toxin A plus physiotherapy and €9,452.25 for patient treated with physiotherapy only. The sensitivity analysis confirmed the results of the base case. Conclusions Based on data from a Delphi Panel survey, we performed a cost minimization analysis focused on the use of physiotherapy only or botulinum toxin A plus physiotherapy for spasticity following a stroke. From the Italian NHS perspective, botulinum toxin A plus physiotherapy is a cost-saving strategy compared with physiotherapy only in the treatment of patients with spasticity following stroke. PubDate: 2013-07-04
Abstract: Background Nursing Home (NH) residents are elderly subjects characterized by physical or mental disorders that often lead to permanent disability. The number of elderly individuals is constantly increasing in the Western world, with significant implications in terms of health assistance needs and expenditure. Objective To estimate the health expenditure allocated to NH and to identify how to reduce costs meanwhile improving services. Methods An observational study was conducted between January and December 2011 in 25 NHs, and involved 2010 elderly residents, assisted by the Local Health Authority No. 9, Treviso, Italy. For each patient, cost of hospitalizations, specialist visits, drug prescriptions and medical devices were collected and analysed. Results Costs for the assistance of elderly NH residents were different if the NHs were counselled by a pharmacist or not. The pharmacist intervention can yield important savings for the NHs participating in the project. Conclusion The collaboration between pharmacist and medical doctors/nurses improves the therapeutic appropriateness of treatments for elderly NH residents, with a positive budget impact. PubDate: 2013-06-08
Abstract: Background The often modest therapeutic value, the uncertain level of innovation, and the high costs of new drugs suggest a pressing need for early evaluation of emerging pharmaceuticals. The Italian Horizon Scanning Project (IHSP) critically reports on emerging drugs in order to timely assess their potential impact on the National Health System. Methods IHSP identifies, filters and prioritizes emerging drugs for which a European Marketing Authorization (MA) is expected within 12–36 months. The final New Product Information Report, issued 12 months before the MA, critically reports on efficacy and safety of selected drugs, on their possible level of innovation, place in therapy and social and economic impact. Results Since 2008, 39 new drugs were prioritized (corresponding to 44 indications) due to (i) their potential high epidemiological and economic impact; (ii) the limited availability or the complete lack of treatments; (iii) the uncertainty of the possible place in therapy of the emerging drug; (iv) the possible better efficacy and/or safety profile or possible better compliance of the new medicine versus the available therapies. Among the 39 drugs, 14 active principles were indicated in cancer patients, eight for cardiovascular diseases, and four for multiple sclerosis. Conclusions Horizon Scanning is a useful tool to support policy-makers in allocating resources more efficiently. PubDate: 2013-06-08
Abstract: Background In 2010 the Italian Government approved a law guaranteeing the access to pain therapies to patients suffering from chronic pain. Data on clinical pathways and costs are now needed to inform the decision-making process on these therapies, and in particular on Spinal Cord Stimulation (SCS), a technologically advanced option for the treatment of chronic pain. Objective To provide Italian health-policy makers with country-specific data on SCS procedures in terms of hospital management and hospitalization costs. Methods The study involved two Italian Centers, in which the learning curve for SCS is considered completed. Through a micro-costing approach and interviews to the medical staffs, the clinical pathway (from admission to discharge) of SCS procedures and the related costs were investigated. Resource consumption captured in the analysis was: staff, operating room, disposables, medical devices, drugs, diagnostic tests and general expenses. Results Depending on the device implanted and on the clinical management, the total hospitalization costs may vary from €17,500 to €38,400. These costs appear to be higher than the basic compensation recognized to the Italian hospitals through the DRG system. Conclusions Following the Italian “Pain Law”, this study could be useful in the process of a wider adoption of pain therapies, and in particular SCS. PubDate: 2013-06-08
Abstract: Abstract In recent years, anticancer drug treatment was the main driver of hospital pharmaceutical expenditure. This expenditure is likely to increase as a result on the one hand of the entry of new biotechnological drugs, more costly than traditional therapies, and, on the other hand, from the extension of indications of many drugs already on the market. The objective of this study is to analyze the main trials conducted on a sample of anticancer drugs evaluated by the Regional Committee of Veneto Region, highlighting their criticalities. In the last two years, 11 anticancer drugs have been evaluated for one or more therapeutic indications and 13 HTA reports have been produced. Overall, 33 major studies in support of the efficacy have been identified: nine uncontrolled studies, 20 randomized controlled trials (RCTs) and four retrospective analysis of RCTs. Excluding the uncontrolled studies, the overall survival was the primary efficacy endpoint in only 50 % of trials. Because of the availability of many new anticancer drugs, expenditure for their acquisition has increased in importance over the last years and it is necessary to assess correctly the innovation of new technologies and the benefits for patients. PubDate: 2013-06-07
Abstract: Background Inappropriate feeding is a risk factor in many pathological conditions and causes direct and indirect costs. A number of inpatients are malnourished, resulting in complications and hospital stay prolongation. Objectives To compare, with HTA methodology, food distribution systems, i.e. “trolley service” versus “plate”. Materials and methods A review of the literature, analysis of organizational efficiency, a customer satisfaction survey and comparisons between systems were carried out. Results The “plate service” system requires less resources and a spare of time in delivering food to the patients but there remain some organizational activities and caring to patients who need help feeding. The “trolley” system is more economic (cost of a meal €6,650 versus €6,910). In the ethical-social analysis it has been shown a higher working-time availability with the “plate” system, that could be used to assist patients with their meals. Caregiving support must also be considered as a social cost. In the safety analysis, missed nursing care increased the risk of negative outcomes. The “tray” method qualitatively is considered to be better (it meets patient needs, respects patient preferences, allows variations related to changes in clinical conditions). The “cart” system allows portioning standardization, balanced meals, measuring real food intake and limiting any additions or changes. Conclusions There is no clear evidence indicating which system is better. PubDate: 2013-06-07
Abstract: Background The involvement of stakeholders (internal — third party payers, health care organisations and research centres, external — industry and patients, and clinicians) by HTA Organisations is hugely debated. On the one hand their participation may provide important information for the assessment process and could promote consensus over recommendations. On the other hand stakeholders’ involvement increases complexity in the decision-making process. The actual role of stakeholders and reasons for their different involvement in HTA organisations have not been deeply scrutinised so far. The aim of this paper is to investigate these two issues in six European countries, with a focus on those HTA organisations that assess medical devices (France, Germany, England, the Netherlands, Spain, and Sweden). Methods We carried out a literature review (1999–2009), using PubMed, Ebsco, JStore and Wiley Science. In addition, 16 semi-structured interviews were conducted with key personnel in the organisations concerned, consistently with the explorative nature of the study. Results We found huge differences across countries and these differences seem to be due to the administrative tradition, the way the health care system is organised and (even if more doubtful) the role of HTA organisations. External stakeholders are much more involved when the national administrative system is contract-based (e.g. England), whereas an organic conception (e.g. Spain) is more closed to stakeholders’ participation. Internal stakeholders (expecially third party payers) participate more, when the health care system is modeled as social insurance. The impact of administrative tradition and the health care system seem to be less important when recommendations based on HTA are binding and used for policy purposes (reimbursement and, possibly, prices), thus providing for an organisation-specific (and not only country-specific) source of difference. Conclusions It may be concluded that stakeholders’ involvement may be strongly influenced by the general context where the HTA organisations operate. As a consequence, a stakeholders’ involvement model cannot be easily transferred from one country to another. Despite of this, it can be stated that external stakeholders’ involvement was generally increasing, expecially when recommendations are binding: this could provide an opportunity for HTA organisations to achieve consensus in advance, thereby facilitating the implementation of any recommendations made. PubDate: 2012-01-01
Abstract: Abstract Reference to ‘innovation’ in the pharmaceutical context has been applied in different settings and by several authors in these last years. All of them had as main scope to improve the methodology (or reduce discreptionality) in decision making. They reported and discussed methods for selecting and prioritizing their development speeding up the R&D process (fast track, innovation path), valuing the drug in comparison to the current therapies (added value) and/or accelerate the access of patients in a reimbursed environment. The impact generated by the adoption of different methodologies makes the “methodological issue” appealing for HTA agencies, regulators and manufacturers (all of them in clear “conflict of interest” with respect to use of the definition) and seems at the basis of the recent proliferation of several different definitions and processes. Despite these dishomogeneity the core of the evaluations is still represented by the concept of ‘relative therapeutic added value’ and is driven by the choice of comparator or standard of care. A wider approach to ‘pharmaceutical innovation’ should be addressed, trying to match public and private expectations in priority setting for R&D programs, in selecting and weighting the relevant value dimension of new health technologies, managing the issue of how each potential innovation could impact on the sustainability framework and on the social expectation of the society. PubDate: 2012-01-01
Abstract: Abstract Lung cancer is the most common tumor and one of the most aggressive, with rates of survival at 5 years of about 10% in most countries. Studies reported EGFR (Epidermal Growth Factor Receptor) gene activating mutations in 10–15% of NSCLC (Non Small Cell Lung Cancer) in the European population. Molecular assessment of EGFR mutations became mandatory for gefitinib administration in NSCLC patients. Only tumors harboring at least one activating mutation in either exon 18, 19 or 21 are eligible for therapy with this drug. Several methods are available in order to study EGFR mutations, such as direct sequencing and Real Time PCR. Pyrosequencing is a DNA sequencing technique based on the principle of sequencing-by-synthesis and it is characterized by a greater sensitivity compared to direct sequencing. We compared pyrosequencing with Real Time PCR, both combined with CE-IVD approved commercially available kits for EGFR analysis, in terms of effectiveness, economic and logistic impact. In conclusion, although Real Time PCR has a greater sensitivity, pyrosequencing is an effective and reliable method, with an advantage in detecting new mutations whose clinical impact is yet unknown. More studies are needed in order to define which sensitivity level is really correlated to clinical response. PubDate: 2012-01-01
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