Farmeconomia. Health economics and therapeutic pathways
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Economic implications in inflammatory bowel disease: results from a retrospective analysis in an Italian Centre
Full text linkBACKGROUND: Inflammatory bowel disease (IBD) represents a group of chronic conditions characterized by elevated costs. Over the last years, also a considerable healthcare burden associated with IBD has emerged, due to an increasing use of biological drugs and hospitalization costs. Despite the creation of local or regional databases, data regarding healthcare expenditure are lacking in Italy.AIM: To evaluate the treatment cost (biological drugs and hospitalizations) for patients with ulcerative colitis (UC) or Crohn’s disease (CD) treated with biological drugs.METHODS: Disease severity was evaluated by clinical scores (partial Mayo score and Harvey Bradshaw Index). We analyzed retrospectively patients treated with biologics referred to our IBD Unit between May 2015-April 2016 who underwent at least six months of follow-up (last visit October 2016). We calculated a mean cost per month of treatment for each patient. We also investigated the presence of any correlation between the monthly cost of treatment and demographic or clinical variables.RESULTS: We enrolled 142 patients (52 UC, mean age 44.3 years, male 40.4%; 90 CD, mean age 38.8 years, male 56.7%). About half of CD patients (48.9%) underwent previous intestinal surgery. The disease severity was higher in UC group vs CD group. In UC group infliximab was the most prescribed biologic (51.9%), followed by golimumab (26.9%) and adalimumab (21.2%). While CD patients were treated with adalimumab in 54.4% and infliximab in 45.6%. The mean monthly cost of treatment was € 1,235.41 ± 358.38 for UC and € 1,148.92 ± 337.36 for CD (p = 0.16). In both groups expenditure due to biologics amounts for more than 80%. We found a correlation between costs and disease activity (UC: p < 0.01; CD: p < 0.01).CONCLUSION: The main cost is due to biological drugs, but patients enrolled were the most severe in comparison to the whole IBD population under conventional therapy. As no cost differences were found between biologic drugs and the way of administration (intravenous or subcutaneous), the therapeutic choice should be driven by clinical reasons and not only economic ones
Equilibrium between resources and expenditure of health sector of Social Security Fund: a case study of Iran
Full text linkIn Iran, Social Security is the most important institution of social insurance fund, currently insuring more than a half of country population, and it has a significant role in fulfilling short-term and long-term commitments. Therefore investigation of the balance of resources and expenditure of health sector of the fund can be a scientific process of the funding the future and can pave the way to provide necessary revisions in this sector. Analyzing equilibrium between resources and expenditure of health sector of Social Security Fund in the past years, the present study offers recommendations for improving it in terms of parametric and structural dimensions. The methodology includes documentary library methods and statistical part is descriptive using Excel. Findings indicated that, regarding the present lack of balance of resources and expenditure of health sector, keeping on with the present conditions can lead to many crises. As a result, to escape from the present conditions of the funds where lack of balance of resources and expenditure exists, carrying out parametric and management-structural revisions seems necessary
[Reply to Letter to the Editor in reference to " Clinical and economic evaluation of the introduction of the combinazion trametinib + dabrafenib in the management of advanced melanoma in the Italian market”]
No full text[Use of Kovaltry® in patients with Hemophilia A: clinical and economical aspects from the pivotal clinical trials]
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[Organizational and financial aspects of the introduction of Botox® in the clinical diagnostic therapeutic process of chronic migraine at a Local Health Unit in Italy]
Full text linkBACKGROUND: Existing literature shows that the use of Botox®/onabotulinumtoxinA (BT) in chronic migraine (CM) is promising from a cost-effectiveness standpoint and the use of a clinical diagnostic therapeutic process (CDTP) dedicated to CM allows a reduction of pathology costs. The inclusion of BT in chronic migraine therapy at a Roman ASL involves the need to investigate the real treatment costs of a CDTP and to measure how a targeted organizational CDTP strategy for CM allows insuring treatment accessibility, sustainability, and appropriateness.OBJECTIVE: To conduct a cost-effectiveness analysis of providing administration of BT in patients with CM using real world data from an ASL in Rome.METHODS: The real world cost data for approximately 215 anonymous patients were summarized. The cost data were extrapolated from the database of the ASL and they populated a Markov decision model developed by Allergan. The analysis is based on a decision model populated with real drug and service cost data, for the years 2010-2012. The financial assessment was conducted from the viewpoint of the Italian National Health Service.RESULTS: Over a 2 year temporal horizon, incremental BT costs, compared to a placebo, are equal to € 261 against an incremental gain of 0.0655 QALY in favor of BT. The ratio between costs and incremental QALY generates an ICER of 3,983 €/QALY, favorable and below the acceptability threshold used by many countries for reimbursement decisions (25,000-40,000 € per QALY gained).CONCLUSIONS: The inclusion of BT in the CDTP dedicated to CM of an Italian ASL improves both clinical outcomes of the patients and the allocation of the SSN available resources.[Article in Italian
Simulating the development and progression of Chronic Kidney Disease and osteoporosis in people living with HIV
Full text linkThe “chronicization” of HIV infection brings about a growing necessity to attentively evaluate current and potential complications when prescribing the individual therapeutic regimen. Starting from this need, we developed two HIV-comorbidity simulators that, basing on the evidence available in medical literature and starting from the current clinical and demographic features of the individual patient, project and compare the risks of developing and worsening of nephropathy and osteopathy associated with possible ARV regimens. These simulators are embedded in a desktop, user-friendly software thought to be used by the treating physician during prescription discussion with his/her patients, in order to highlight expected clinical outcomes and healthcare resource consumption that may differ according to the therapeutic strategy selected. In this article we present the sources and methods used in developing the mathematical models, alongside a set of examples and the results of cohort-level validation runs
Budget impact analysis of the use of daclatasvir in Italy for the treatment of Hepatitis C Virus (HCV) genotype 3 patients
Full text linkBACKGROUND: Hepatitis C Virus (HCV) infection represents a global health problem, leading to chronic cirrhosis, hepatocellular carcinoma (HCC), hepatic decompensation and liver transplant. The aim of the study was the evaluation of the impact on the budget of the Italian National Health Service (INHS) of the use of Daclatasvir (DCV) for the treatment of HCV genotype 3 in patients with advanced fibrosis.METHODS: An analytical decision model with a five year time horizon was implemented. Two scenarios were considered: a. 100% of market share for Interferon (INF-α)+Ribavirin (RBV)+Sofosbuvir (SOF) for 12 weeks; b. SOF+DCV+RBV for 24 weeks with annual market shares of 50% in 2015 and 2016, 55% in 2017 and 2018, 60% in 2019, and INF-α+RBV+SOF for 12 weeks with the remaining market shares. Every annual cycle a percentage of patients equal to the effectiveness of the antiviral treatment reach a sustained virologic response and during the first year of treatment patients may experience treatment related adverse events. The costs considered (2015) are those of the antiviral therapy, and direct medical costs for health state and adverse events management. Univariate and multivariate sensitivity analyses were performed.RESULTS: DCV would lead to an increase of the costs for the INHS (year 1 +21.31 millions, year 2 +21.35 millions, year 3 + 23.37 millions, year 4 + 23.26 millions and year 5 +16.37 millions). The sensitivity analysis confirmed the robustness of the results.CONCLUSIONS: The use of DCV is likely to have a short term impact on the INHS budget increasing resources use compared to the sole use of INF-α+RBV+SOF. However, a trend of reduction of the costs increase is observed due to the management of health states and adverse events which may lead to the possibility to reduce costs in the long term
Analysis of the treatment cost of HIV/AIDS in Turkey
No full textOBJECTIVE: Infection with the human immunodeficiency virus (HIV), the causative agent of acquired immune deficiency syndrome (AIDS), is a major global health problem. Patients with HIV can live normal lives with today’s new treatment options. As the treatment is generally successful, the life expectancy of patients infected with HIV is rising. As a result, the economic burden of HIV treatment on health systems is set to increase. According to the Ministry of Health, there were more than 6000 HIV-positive patients in Turkey in 2013. The aim of this study was to determine the direct costs of HIV treatment in Turkey.METHOD: A retrospective data analysis was performed from the reimbursement agency perspective. Data for 252 patients at a university hospital in Ankara from 2001 to 2012 were used for the analysis. The average costs of treatment per HIV patient and the average costs per HIV patient, depending on the state of the patient’s health, were calculated. The latter was determined according to the number of CD4 cells/ml, as defined by the CDC’s classification system for HIV infection. The cost of treatment was calculated based on published reimbursement prices in 2013, per patient per year.RESULTS: The CD4 values of 25.3%, 29%, and 45.7% of the 252 patients were <100 cells/mm3, 100–300 cells/mm3, and >300 cells/mm3, respectively. The treatment costs per patient per year for 2013 for those with CD4 values of <100 cells/ mm3, 100–300 cells/mm3, and >300+ cells/mm3 were 2,211.54, and 3,344.64 for 2013.CONCLUSION: This analysis is unique to Turkey and calculates the cost only of HIV treatment in Turkey. Lower CD4 values are associated with higher treatment costs. Appropriate HIV treatment is crucial for controlling CD4 values and lowering the treatment costs of HIV patients. These findings need to be considered by policy makers who may need to focus on HIV
[Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management]
Full text linkBACKGROUND: Peginterferon beta-1a is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (RRMS). The efficacy and safety of peginterferon beta-1a was demonstrated in the placebo-controlled ADVANCE trial.OBJECTIVE: The objective of this study was to assess the cost-effectiveness of peginterferon beta-1a as compared with injectable first-line treatments for RRMS in Italy.METHODS: The cost-effectiveness analysis was developed through a Markov model with lifetime simulation in the perspective of the Italian National Healthcare Service (NHS). It was added an alternative scenario to take into account the Italian societal perspective. Outcomes were measured in terms of life years (LYs), quality adjusted life years (QALYs), lifetime costs and incremental cost-effectiveness ratio (ICER). The natural progression of the disease was informed by the published literature and previously published modelling exercises. The efficacy of treatments was simulated as reduction of disability progression (EDSS) and relapse rate. Efficacy data were derived from a published network meta-analysis. Unit costs were based on current prices and tariffs, and the published literature. A 3.5% discount rate was applied to costs and outcomes. One-way and probabilistic sensitivity analyses were developed and cost-effectiveness acceptability curves generated.RESULTS: Peginterferon beta-1a was more effective than the comparators in terms of survival (19.94 vs.19.68-19.81 discounted LYs, respectively), and QALYs (9.07 vs. 8.06 and 8.55 discounted QALY, respectively). In the perspective of the Italian NHS, the ICER was € 11,111/QALY vs. interferon beta-1a 30 µg, € 12,604/QALY vs. interferon beta-1a 22 µg, € 10,580/QALY and € 16,702/QALY vs. interferon beta-1b 250 µg and € 22,023/QALY vs. glatiramer acetate 20 mg. Peginterferon beta-1a dominated interferon beta-1a 44 µg. In the societal perspective, peginterferon beta-1a was dominant due to being more effective and with a lower social cost compared to first-line injectable treatments (interferon beta -1a, interferon beta-1b, glatiramer acetate) for RRMS. The outcomes of the sensitivity analyses confirmed the trend of the base case results.CONCLUSIONS: Peginterferon beta-1a shows a favourable pharmaco-economic profile for the treatment of RRMS. Even if an official threshold for the cost-effectiveness does not exist in Italy, the ICER values obtained were far below the commonly accepted thresholds (30,000-50,000 €/per QALY gained).[Article in Italian