Farmeconomia. Health economics and therapeutic pathways
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Oncology monoclonal antibodies expenditure trends and reimbursement projections in the emerging Balkan market
Full text linkMonoclonal antibodies applied in clinical oncology present a therapeutic promise for many patients with cancer. Nevertheless these expensive protocols are associated with extremely high acquisition and administration costs. The issue of societal affordability of such treatment options is particularly at stake among middle income European economies. Medicines Agency of Serbia issues regular annual reports on public expenditure on pharmaceuticals since 2004. According to these official data total public expenditure on drugs doubled from 2004-2012 (from € 339,279,304 to € 742,013,976). During the same nine years public expenditure on antineoplastic pharmaceuticals was rising at much faster pace, approximately five times from € 10,297,616 in 2004 to € 51,223,474 in 2012. Absolutely record growth belongs to the value of turnover of monoclonal antibodies indicated in diverse malignancies. These costs became almost twenty times higher in 2012 compared to 2004 (€ 19,687,454 towards € 1,033,313 in the past). National pharmaceutical expenditure trend projections in this country show strong recovery in 2012 after severe blow to the overall health care market imposed by the worldwide crisis. Universal health insurance coverage and sustainable health care financing provision will remain difficult issues for Balkan economies in years to come. Although monoclonal antibodies exhibit undisputed therapeutic efficiency in certain malignant disorders, cost-effectiveness estimates must be taken into consideration by policy makers deciding on reimbursement
Comparative pharmacoeconomic assessment of apixaban vs. standard of care for the prevention of stroke in Italian atrial fibrillation patients
Full text linkOBJECTIVES: The aim of this study was to evaluate the cost‑effectiveness of apixaban in the prevention of thromboembolic events in patients with non‑valvular atrial fibrillation (NVAF) relatively to standard of care (warfarin or aspirin) from the Italian National Health System (SSN) perspective.METHODS: A previously published lifetime Markov model was adapted for Italian context. Clinical effectiveness data were acquired from head‑to‑head randomized trials (ARISTOTLE and AVERROES); main events considered in the model were ischemic and hemorrhagic stroke, systemic thromboembolism, bleeds (both major and clinically relevant minor) and cardiovascular hospitalizations, besides treatment discontinuations. Expected survival was projected beyond trial duration using national mortality data adjusted for individual clinical risks and adjusted by utility weights for health states acquired from literature. Unit costs were collected from published Italian sources and actualized to 2013. Costs and health gains accruing after the first year were discounted at an annual 3.5% rate. The primary outcome measure of the economic evaluation was the incremental cost effectiveness ratio (ICER), where effectiveness is measured in terms of life‑years and quality adjusted life‑years gained. Deterministic and probabilistic sensitivity analyses (PSA) were carried out to assess the effect of input uncertainty.RESULTS: Apixaban is expected to reduce the incidence of ischemic events relative to aspirin and to improve bleeding safety profile when compared to warfarin. Incremental LYs (0.31/0.19), QALYs (0.28/0.20), and costs (1,932/1,104) are predicted with the use of apixaban relative to aspirin and warfarin, respectively. The ICERs of apixaban were € 6,794 and € 5,607 per QALY gained, respectively. In PSA, the probability of apixaban being cost effective relative to aspirin and warfarin was 95% and 93%, respectively, for a WTP threshold of € 20,000 per QALY gained. Univariate analyses indicate that results were most sensitive to variations of the absolute risk reduction for cardiovascular events with apixaban.CONCLUSIONS: Apixaban is expected to increase life expectancy and quality‑adjusted life expectancy, but also costs dedicated to Italian NVAF patients, as compared to standard of care. The resulting ICERs have high probabilities of being below the conventional thresholds of WTP for health benefits of the SSN, indicating efficient allocation of health care resources
Economic burden of Communicable and Non-communicable Diseases in Jamaica: Is our research focus where it should be?
Full text linkBudget impact analysis of the use of paricalcitol for the treatment of secondary hyperparathyroidism in chronic kidney disease
Full text linkOBJECTIVE: Evaluation of the budget impact of the use of paricalcitol (compared to alternative treatment) for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) when used at two different timing of therapy.METHODS: Two Markov models related to a different timing of treatment have been developed: the intermediate stage of chronic kidney disease (CKD3) and the dialysis stage. The analysis was conducted with the perspective of the Italian National Health System and over a 5-year time horizon. The clinical and economic data used in the model were derived from the literature and other assumptions were made based on the opinion of clinical experts. Univariate sensitivity analysis was conducted to test the robustness of the results.RESULTS: The base case shows that starting paricalcitol treatment from the dialysis stage (considering 13,311 possible candidates) is associated with a reduction in direct costs from € 1,782,921,351 to € 1,622,357,209 over 5 years. Furthermore, considering a collective of 1,000 subjects eligible and starting treatment with paricalcitol since the intermediate stages of the CKD, is associated with an overall cost saving of € 1,197,500.DISCUSSION AND CONCLUSIONS: Paricalcitol is expected to be cost-saving in patients with SHPT in Italy considering both the therapeutic indications of the drug. Moreover, despite the higher cost of using paricalcitol in pre-dialysis stage, an early treatment of SHPT determine an overall decrease in direct medical costs
Pharmacoeconomic aspects related to the 13-valent pneumococcal conjugate vaccine: preliminary analysis of the data from the ASL of Viterbo
Full text linkINTRODUCTION: Streptococcus pneumoniae is a pathogen of considerable importance to public health because it causes morbidity and mortality on the world population. It has more than 90 serotypes with different epidemiological characteristics and pathogenicity. Some categories of the population are particularly vulnerable to infection. The Regional Plan for the Prevention of Lazio for vaccination, based on the national plan for the prevention for vaccination involves the active offer of vaccination no 13-valent PCV, with a target of at least 90% in children 24 months of age.OBJECTIVE: To begin to assess the real economic impact of disease attributable to Pneumococcus, starting from the analysis of hospital discharge records (SDO) of the Viterbo\u27s ASL.METHODS: The model is structured follows the observational approach of 33 months, from January 2012 to September 2014, selecting the SDO with a principal diagnosis of Streptococcus Pneumoniae diseases and those with a principal diagnosis of respiratory diseases without etiological diagnosis, which, with good approximation, it can be considered responsible for Streptococcus pneumoniae 40%.RESULTS: From the preliminary analysis of the data, evaluating only patients diagnosed due to Pneumococcus, is known as the only pediatric cases hospitalized are between 0 and 1 year. Therefore one might assume that vaccination disbursed to the child population with 13-valent PCV, has ensured effective protection to persons of the age group 2-18 years.CONCLUSIONS: The importance of this study is the observation conducted on an ASL, (similar in size and catchment area to many Italian realty) of the vaccination coverage effects, as provided by PRPV Lazio Region, on hospitalizations by Pneumococcus. The study offers a moment of reflection for decision makers, as it would be interesting to conduct pharmacoeconomic’s analysis in the presence of vaccination strategies extended to adults, especially for those at risk, associated with diagnostic tests etiological more specific
A new decision model for economic evaluation of novel therapies for HCV
Full text linkIn 2014, the European Medicines Agency (EMA) has given the license to two new direct-acting antiviral: sofosbuvir and simeprevir. The evidence provided by the studies, reported a high rate of SVR even in patients with decompensated cirrhosis. This and other innovative elements are potentially adept at changing the entire natural course of HCV. However, the dramatic prevalence rates of HCV observed in Italy, and the high prices that are expected to be required by the pharmaceutical industry, raises some critical issues about how to regulate access to such drugs. The objective of this article is to present a new decision model for the evaluation of novel therapies for HCV. This model is intended to provide a tool for the decision-maker that seeks to address the main issues related to the introduction of HCV new treatments. The model that we have structured follows the classic Bayesian approach, using data from reference literature for staging the action of treatments depending on the level of fibrosis (F0, F1, F2, F3, F4). The model is designed to consider patients with all genotypes and allows to make comparisons between innovative and traditional therapies (dual, triple, IFN free, PI combinations, etc.), for both experienced and naïve patients. In addition, the model is used to simulate mixed cohorts of patients, representing a population with HCV with different levels of fibrosis and different genotypes. To show the potential of the model, we created some simple scenarios assuming different levels of SVR and pricing. The results of our model show that, even assuming an SVR rate of 100%, the administration of new treatments for HCV subjects F1 / 2 has an incremental cost-effectiveness ratio not sustainable. In contrast, for the subjects F3 and F4, low incremental SVR rates and an incremental cost of the innovative therapy of € 40,000 would be cost effective. The added value of this model is its versatility and applicability to diverse assessment needs. In addition, the model offers an opportunity for reflection even to the industry, which in the years to come will have to develop strategies for entering the market and offer sustainable prices for decision-makers and at the same time remunerate the investment in research and development consistently with the expectations of the shareholders
The economic impact associated with cerebrovascular events related to non-valvular atrial fibrillation (NVAF) in Italy: the role of apixaban
Full text linkThe trend of pharmaceutical expenditure in Italy: from the report OsMed 2013 to the monitoring 2014
Full text linkHow do European patients feel about the listening skills of primary care physicians? Results from the EUprimecare Project
Full text linkOBJECTIVE: EUprimecare is a study funded by the 7th Framework Programme of the European Union aimed at analyzing the quality of the different models of primary care (PC) in Europe. The objective of this study was to describe and analyze the determinants associated with patient satisfaction with the listening skills of their PC physicians.METHODS: Telephone population survey in each EUprimecare consortium countries (Germany, Spain, Estonia, Finland, Hungary, Italy and Lithuania) among PC users. The questionnaire included sociodemographic variables, health status, use and satisfaction with PC services. The survey was conducted in 3020 patients. It was developed descriptive analysis, bivariate correlations and ordinal regression model to study the direct relation between levels of satisfaction and the explanatory variables on demographics, state and health services for patients. We show the regression coefficients (β) with 95% confidence interval and statistical significance associated.RESULTS: We found significant relation between the level of satisfaction and age (β = 0.016), visits to specialist (β = ‑0.040), having a general practitioner (GP) (β = 0.619), having a chronic disease (β = 0.255), measuring weight, cholesterol and blood pressure (β = 0.650), countries (β1 Estonia= 0.938; β2 Germany = 0.469; β3 Lithuania = 0.483; β5 Italy = 0.544 and β6 Hungary = 1.010) and a better perception of health status (β = 0.388). Specialist visits have a negative influence with the higher degree of satisfaction.CONCLUSIONS: Overall, the results indicate some areas that may be related to greater doctor‑patient satisfaction. Different factors are converging to explain satisfaction with listening skills