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      New Highly Active Antiretroviral drugs and generic drugs for the treatment of HIV infection: a budget impact analysis on the Italian National Health Service (Lombardy Region, Northern Italy)

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          Abstract

          Background

          In the healthcare sector, it is crucial to identify sustainable strategies in order to allow the introduction and use of innovative technologies. Now, and over the next few years, the expiry of patents for different antiretroviral drugs offers an opportunity to increase the efficiency of resources allocation. The aim of the present study was to assess the impact, on the budget of the Italian National Healthcare Service, of generic antiretroviral drugs and of new antiretroviral drugs entering the market from 2015 to 2019.

          Methods

          A budget impact model was developed in order to forecast the rate of use of ARTs, based on trends observed within the Lombardy Region (Italy), on clinical experts’ opinion, and the consequent impact on the Italian NHS budget in a five year time horizon. Different scenarios were developed, considering the sole introduction of generic drugs, of new drugs, and their cumulative effects. A multivariate sensitivity analysis was also performed.

          Results

          The cumulative use of generic drugs and new drugs would lead to annual savings of 4.6 million € (-0.6 %) in 2015; 16.9 million € (-2.1 %) in 2016; 19.4 million € (-2.4 %) in 2017; 51.1 million € (-6.1 %) in 2018 and -110.3 million € (-12.8 %) in 2019. The impact of new drugs in percentage terms is +2.0 % in 2015, +3.4 % in 2016, +3.9 % in 2017, +5.7 % in 2018 and +7.7 % in 2019. The impact of generic drugs would lead to savings of 4.9 million € in 2015, 18.6 million € in 2016, 22.8 million € in 2017, 76.5 million € in 2018 and 187.4 million € in 2019.

          The sensitivity analysis showed annual mean savings for the Italian NHS ranging from 12.6 million €, -1.5 % compared to the base case scenario (decreasing all the rates of transition used in the simulation, and increasing the cost of generic drugs) to 76.0 million €, -9.1 % (increasing all the rates of transition used in the simulation, and decreasing the cost of generic and new drugs).

          Conclusions

          The use of antiretroviral generic drugs may lead to savings that would compensate the expenditure increase due to new, innovative drugs available on the market.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12879-015-1077-7) contains supplementary material, which is available to authorized users.

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          Most cited references11

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          Delivering affordable cancer care in high-income countries.

          The burden of cancer is growing, and the disease is becoming a major economic expenditure for all developed countries. In 2008, the worldwide cost of cancer due to premature death and disability (not including direct medical costs) was estimated to be US$895 billion. This is not simply due to an increase in absolute numbers, but also the rate of increase of expenditure on cancer. What are the drivers and solutions to the so-called cancer-cost curve in developed countries? How are we going to afford to deliver high quality and equitable care? Here, expert opinion from health-care professionals, policy makers, and cancer survivors has been gathered to address the barriers and solutions to delivering affordable cancer care. Although many of the drivers and themes are specific to a particular field-eg, the huge development costs for cancer medicines-there is strong concordance running through each contribution. Several drivers of cost, such as over-use, rapid expansion, and shortening life cycles of cancer technologies (such as medicines and imaging modalities), and the lack of suitable clinical research and integrated health economic studies, have converged with more defensive medical practice, a less informed regulatory system, a lack of evidence-based sociopolitical debate, and a declining degree of fairness for all patients with cancer. Urgent solutions range from re-engineering of the macroeconomic basis of cancer costs (eg, value-based approaches to bend the cost curve and allow cost-saving technologies), greater education of policy makers, and an informed and transparent regulatory system. A radical shift in cancer policy is also required. Political toleration of unfairness in access to affordable cancer treatment is unacceptable. The cancer profession and industry should take responsibility and not accept a substandard evidence base and an ethos of very small benefit at whatever cost; rather, we need delivery of fair prices and real value from new technologies. Copyright © 2011 Elsevier Ltd. All rights reserved.
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            HIV drug development: the next 25 years.

            The development of drugs for HIV infection began soon after the virus was discovered 25 years ago. Since then, progress has been substantial, but numerous uncertainties persist about the best way to manage this disease. Here we review the current treatment options, consider novel mechanisms that can be exploited for existing drug targets, and explore the potential of novel targets. With a view to the next quarter century, we consider whether drug resistance can be avoided, which drug classes will be favoured over others, which strategies are most likely to succeed, and the potential impact of pharmacogenomics and individualized therapy.
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              High and rising health care costs. Part 2: technologic innovation.

              Technologic innovation, in combination with weak cost-containment measures, is a major factor in high and rising health care costs. Evidence suggests that improved health care technologies generally increase rather than reduce health care expenditures. Greater availability of such technologies as magnetic resonance imaging, computed tomography, coronary artery bypass graft, angioplasty, cardiac and neonatal intensive care units, positron emission tomography, and radiation oncology facilities is associated with greater per capita use and higher spending on these services. Because the spread of new technologies is relatively unrestrained in the United States, many of these technologies are used to a greater extent than in other nations, and the United States thereby incurs higher health care costs. Nations with a greater degree of health system integration have relied on expenditure controls and global budgets to control costs. Although diffusion of technology takes place more slowly in more tightly budgeted systems, the use of innovative technologies in those systems tends to catch up over time.
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                Author and article information

                Contributors
                urestelli@gmail.com
                francesca.scolari2@gmail.com
                pa.bonfanti@ospedale.lecco.it
                d.croce@tiscali.it
                rizzardini.giuliano@hsacco.it
                Journal
                BMC Infect Dis
                BMC Infect. Dis
                BMC Infectious Diseases
                BioMed Central (London )
                1471-2334
                11 August 2015
                11 August 2015
                2015
                : 15
                : 323
                Affiliations
                [ ]Centre for Research on Organisation, Innovation and Leadership in Healthcare (CROILS), IRCCS Ospedale San Raffaele, Milan, Italy
                [ ]School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
                [ ]Department of Infectious and Tropical Diseases, A. Manzoni Hospital, Lecco, Italy
                [ ]First and Second Divisions of Infectious Diseases, “Luigi Sacco” Hospital, Milan, Italy
                [ ]School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
                Article
                1077
                10.1186/s12879-015-1077-7
                4531431
                26259842
                2a905f6c-d8f4-4e59-b87e-7dbcb6ed5d1d
                © Restelli et al. 2015

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 3 February 2015
                : 31 July 2015
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Infectious disease & Microbiology
                Infectious disease & Microbiology

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