Farmeconomia. Health economics and therapeutic pathways
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[Tecfidera® (delayed-release dimethylfumarate) in the treatment of relapsing-remitting multiple sclerosis]
No full textThe present health technology assessment (HTA) evaluates the clinical and economic profile of delayed-release dimethylfumarate (DMF, also known as gastro-resistant DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in Italy. Chapter 1 briefly introduces the condition (multiple sclerosis and, more specifically, the relapsing-remitting form) and provides an overall description of the main therapeutic options for physicians, in terms of clinical evidence, regulatory status in Europe and approval status and reimbursement (refunding) criteria in Italy. In the next sections (Chapters 2-5), key-topics regarding RRMS are analysed: epidemiology, clinical burden, quality of life/social impact and the economic implications for healthcare services, patients and society. In Chapter 6, the clinical evidence supporting the use of DMF in RRMS is summarized. Data from phase III randomized clinical trials (DEFINE, CONFIRM), plus the pooled post-hoc analysis of the two studies, were evaluated to assess the level of clinical benefit provided by DMF. Finally, in Chapter 7, a review of the health economic evidence assessing DMF is performed, with a specific focus on Italy. Overall, the methodological quality of registration studies, together with the robustness and consistency of the study results, support the conclusion that DMF is an effective and safe treatment for RRMS. The economic assessment of DMF in Italy, based on cost-effectiveness and budget impact analyses (adopting clinical input data from a mixed treatment comparison and economic input data relative to the Italian healthcare setting), confirm that DMF is a cost-effective and economically sustainable treatment for the Italian National Healthcare Service. These findings are in line with the results of most international publications and the assessments from well-recognized HTA agencies (e.g. NICE/SMC). In summary, both the clinical and economic evidence analyzed in this HTA substantiate DMF as an important therapeutic option for the treatment of RRMS
A cost-effectiveness analysis of E/C/F/TAF vs three boosted regimens in the Italian context
Full text linkBACKGROUND: Highly Active Antiretroviral Therapy (HAART) has transformed HIV into a lifelong condition. Following the chronicity of the disease, and significant increase in lifespan – the prevalence of comorbidities increased in HIV+ subjects that are exposed both to a higher risk of developing cardiovascular disease, renal disease, osteopenia/osteoporosis and diabetes, and to the risk of developing them early. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate (E/C/F/TAF), a complete, Single-Tablet antiretroviral Regimen (STR) that combines the effectiveness and tolerability of integrase inhibitors with an innovative backbone was recently introduced in Italy. Compared to Tenofovir Disoproxil Fumarate (TDF), TAF reaches the sites of action more efficiently, reducing tenofovir plasma concentration to more than 90% and the risk of off-target effects.OBJECTIVE: A patient-level micro-simulation model was adapted to the Italian context to evaluate E/C/F/TAF cost-effectiveness vs three boosted regimens for HIV+ patients treatment.METHODS: A Markov micro-simulation model was adapted to the Italian context for the evaluation of the cost-effectiveness in patients with HIV. The total cost per patient accounts for drug therapies and the management of adverse events and comorbidities. The quality-adjusted life expectancy (in QALYs) is calculated by weighing the years of life lived by the utility weights. A 70-year time horizon was adopted to simulate a lifetime analysis; shorter time horizons were considered in the sensitivity analyses. 3.5% discount rate was applied both for costs and future benefits. The rate of virologic suppression at 48 weeks with E/C/F/TAF is 92.3%; for the other treatments such proportion is calculated by applying to the reference rate the relative risks, as calculated in a recent network meta-analysis (NMA). Alternative treatments considered in this analysis are three boosted regimens commonly used in Italy: tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat in STR; tenofovir disoproxil fumarate/emtricitabine + darunavir/ritonavir; tenofovir disoproxil fumarate/emtricitabine + atazanavir/ritonavir.RESULTS: E/C/F/TAF improves survival and quality of life (20.17 LY and 14.89 QALY), with the lowest total cost (€ 280,528), thus resulting dominant over three comparators considered as starting therapy. The sensitivity analysis confirms the results of the base case: at a willingness-to-pay threshold of € 30,000 per QALY, the E/C/F/TAF strategy is the most cost-effective, with a 90% probability and it is the most cost-effective even with a threshold of € 10,000 per QALY, with a 50% probability.CONCLUSION: E/C/F/TAF can be a sustainable alternative to currently available treatments, combining the advantage of the STR to lower risks of kidney and bone damage than observed in regimens based on TDF
[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 textVarenicline treatment for smoking cessation in high risk patients: a budget impact analysis
Full text linkINTRODUCTION: The promotion of smoking cessation is a worldwide Public Health priority.OBJECTIVE: To estimate the budget impact on the Italian National Health Service (NHS) of the access to reimbursement of varenicline for the treatment of high risk patients with bronchopulmonary, diabetic and cardiovascular diseases.METHODS: A closed-group Markov model was developed in order to compare the costs incurred by the NHS to promote smoking cessation with cessation-related savings, using an alternative scenario in which aids to cessation are not reimbursed by the NHS. The analysis was conducted over a 5-year time horizon, in the perspective of the Italian NHS. Efficacy was expressed in terms of smoke abstinence for at least one year, and data was derived from clinical trials; the savings associated with smoking cessation were derived from cost-of-illness studies.RESULTS: The results show how costs would concentrate in the first year: they are estimated at € 200.6 million, of which € 162.4 million for drug therapy and € 38.2 million for counseling. Average annual savings over the first five years are estimated at € 77.7 million, with a cumulative net impact at 5 years of € -188.0 million (cost-saving). The analysis appears to be robust: sensitivity analyses show that the covering of initial costs occurs in any case between the third and fourth year, and that the treatment remains cost-saving at 5 years.CONCLUSIONS: The financial impact on the Italian NHS of the reimbursement of varenicline for the treatment of high risk smoking population would be a sustainable healthcare policy, resulting in cost savings starting from the fourth year
Utilization patterns of complementary and alternative medicine in Australia, Canada and the United States: popularity of dietary supplements, mind-body and manipulative therapies
Full text linkRecently approved recombinant factor VIII (rFVIII) for the replacement treatment in patients with hemophilia A in Italy
Full text linkBudget impact analysis of dabigatran compared with rivaroxaban in the prevention of the thromboembolic risk in patients with non-valvular atrial fibrillation
Full text linkBACKGROUND: Dabigatran 150 mg BID (D150) and rivaroxaban 20 mg (R20) are indicated for the prevention of thromboembolic events in patients with Non-Valvular Atrial Fibrillation (NVAF). Outcomes from observational study demonstrated that D150 and R20 reduced the rate of thromboembolic events.OBJECTIVE: This analysis estimated the budget impact of the use of D150 and R20 for the treatment of NAFV patients in Italy.METHODS: A budget-impact model (BIM) was developed to estimate the direct costs up to 12 months from an Italian NHS perspective. The resource utilization (drugs and intracranial hemorrhage or major extracranial bleeding event) was derived from an observational study. Only direct medical costs were considered. Ex-factory prices and National Tariffs were considered to estimate the costs of drugs and medical resource used, respectively. The BIM showed the difference of expenditure and clinical events (intracranial hemorrhage or major extracranial bleeding) generated by the base case calculated for current prescription volumes (D150 30%, R20 100%), and for different prescription volume scenarios (D150 at 70% and 100%). Key variables were tested in the sensitivity analysis.RESULTS: D150 was associated with a medical cost offset driven by fewer intracranial hemorrhage and major extracranial bleeding event, these offset the incremental drug cost and results in an annual saving per patient treated (D150: € 1,052.78; R20: € 1,161.23). The present scenario determines an annual cost of € 262,543,583. The impact of total annual costs for the Italian NHS would be lower if D150 prescription volumes would be higher. The total cost is predicted to decrease by 3.8% if the D150 prescription increase to 70% and it is predicted to decrease by 6.7% if the D150 prescription increase to 100%.CONCLUSION: The use of D150, as an alternative to R20 to prevent events in patients with NVAF, could represent a cost-saving option for the Italian NHS
Budget Impact analysis of the first-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) adult patients
Full text linkBackground: Tyrosine kinase inhibitors (TKI) have dramatically improved survival in chronic myeloid leukemia in chronic phase (CML‐CP), with a high percentage of patients reaching a major molecular response (MMR). Recently, several clinical trials demonstrated that some patients with CML-CP who achieve a sustained MMR on tyrosine kinase inhibitor (TKI) therapy can safely discontinue their therapy and attempt treatment-free remission (TFR).Objective: The aim of the study was to evaluate the clinical and economic impact of TFR in naïve patients with CML-CP who start treatment with nilotinib, imatinib or dasatinib as first-line therapy, from the perspective of the Italian National Health Service (NHS).Methods: An Excel-based budget impact model was developed, in order to estimate the costs of the patients in first-line pharmacological treatment with CML. A specific Markov model was built, to simulate seven years of treatment with different TKIs. A systematic literature review was carried out, to identify the epidemiological and economic data, which were subsequently used to inform the model. The model considers two scenarios: 1) a Standard of Care (SoC) scenario, with the current estimated distribution of patients over the various TKI treatment, versus 2) an innovative scenario, characterized by an increase in the use of nilotinib (+28%) and generic imatinib (+35%) and a decrease in the use of dasatinib (-17%). A one-way deterministic sensitivity analysis was performed, in order to consider the variability of the results as a function of the main parameters considered in the model.Results: The model estimated that 775 patients with CML-CP could be treated with a TKI as first-line drug. The innovative scenario could increase TFR patients by approximately 60% and reduce the costs by more than € 30 million over 7 years. The increase in the use of nilotinib and the generic imatinib would generate a significant expenditure reduction.Conclusions: This study demonstrates the economic effects of discontinuing TKIs in CML-CP patients. The increase in the use of nilotinib and the generic imatinib could generate an increase in the number of patients who achieve TFR, as well as an actual cost reduction
A general model for the estimation of societal costs of lost production and informal care in Italy
Full text linkWe developed a general model for estimating and comparing disease- and treatment-specific lost paid/unpaid production (due to premature death and reduced ability) and informal care received (due to reduced ability) in Italy, starting from survival, demographic and Health-Related Quality of Life (HRQoL) data. Assuming the disease is not selecting a systematically different population in terms of mean wage than the general public, age- and gender-specific yearly production values are estimated combining data from the last Italian Time-Use-Survey on time dedicated to paid and unpaid (household, caring and volunteering) activities, with a) the last Italian Wage-Structure-Survey, for paid activities (Human Capital approach), and b) market prices for an equivalent service, for unpaid production (Proxy Good approach). To avoid double counting, age- and gender-specific maximum care needs are approximated with time dedicated to eating and personal care,reported in TUS. Present monetary values of future productivity and informal care are estimated applying a 3.5% annual discount rate. Lost life years due to a particular condition/treatment are estimated by comparison of its survival curve with the corresponding age- and gender-normalized survival curve of the general Italian population. The degrees of reduced productivity and need for informal care for remaining life years are estimated by comparison of condition-/treatment-specificreported HRQoL data with demographically matched Italian norms. Our results will be useful for cost-effectiveness and budget impact analyses conducted from the perspective of the Italian society and we encourage the inclusion of these costs in economic evaluations to allow decision makers to be fully informed about the costs and consequences of their decisions on healthcare interventions
[Nintedanib for the treatment of idiopathic pulmonary fibrosis in Italy]
No full textTo date, there are few therapeutic answers for Idiopathic pulmonary fibrosis (IPF) and only two pharmacological treatments have a marketing authorization for this disease. Recently nintedanib (Ofev®) has been authorized as a new therapeutic option and its economic profile has been evaluated by international Health Technology Assessment (HTA) bodies. IPF has important implications for everyday life of patients and their carers, negatively influencing their quality of life and bringing heavy economic burden to the NHS and to the entire society. It is, therefore important to consider these aspects for the Italian environment and to perform a pharmacoeconomic evaluation to define the efficiency of nintedanib in IPF by means of a Cost-Utility Analysis (CUA). As IPF is a chronic and progressive disease, a lifetime Markov model has been therefore developed with health states describing the patient’s condition as a combination of lung function and exacerbation history. The cohort entered in the model at different Forced Vital Capacity (FVC%) predicted health states, without exacerbation. The Clinical data used to perform this CUA were derived from clinical trials and the relative efficacy of nintedanib versus the comparator (pirfenidone) was then obtained from a Network Meta-Analysis (NMA) combining data reported in each primary study (INPULSIS 1-2 and TOMORROW trials for nintedanib, and CAPACITY and ASCEND trials for pirfenidone, respectively). At base-case, treatment with nintedanib resulted in a slightly lower estimated total cost vs pirfenidone, better safety profile and lower risk of acute exacerbations with an advantage in Quality Adjusted Life years (QALYs) gained. These results were confirmed by the sensitivity analysis. Although nintedanib appears to be a valuable option for the NHS to treat IPF patients, future data evidence, as long-term or real-life data, will help to confirm these results.[In Italian