Farmeconomia. Health economics and therapeutic pathways
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Precision medicine: key applications and considerations for commercial success & market access
Full text linkCost-effectiveness of intravitreal therapy in Age-Related Macular Degeneration
Full text linkAge-related macular degeneration (AMD) is still referred to as the leading cause of severe and irreversible visual loss world-wide. Advances in medical research have identified vascular endothelial growth factor (VEGF) as an important pathophysiological player in neovascular AMD and intraocular inhibition of VEGF as one of the most efficient therapies. Anti-VEGFs currently used to treat AMD included a monoclonal antibody (bevacizumab), an antibody fragments (ranibizumab), a fusion protein (aflibercept), and an aptamer (pegaptanib). The wide introduction of anti-VEGF therapy has led to an improvement in the prognosis of patients affected by AMD, with a consequent effects on the burden of care due to highly priced drugs, increasing patient numbers, and long-term disease chronicity. Aim of this review is to present an overview of available therapeutic strategies in AMD in term of clinical efficacy and economic sustainability
Economic impact of the use of Hyalubrix® in the treatment of hip osteoarthritis in Italy
Full text linkThe present study aims at evaluating the economic impact of the use of hyaluronic acid (Hyalubrix®60/HyalOne) as an alternative to surgery in the treatment of hip osteoarthritis, consistently with the therapeutic protocol envisaged in the Ortobrix study. To quantify the cost and efficacy of the treatment options under evaluation, the perspective of both the Italian NHS and the Society was considered. To this end, a decision analysis model was created over a 4-year period, to quantify the cost of treatments, procedures and adverse events, as well as the benefits expressed as survival rates and reduced lost workdays. The results show that, since the treatment with Hyalubrix® enables to avoid or delay the need for Total Hip Replacement (THR) surgery, it is possible to reduce mortality, adverse events and total costs. Hyalubrix®, given in the hip by ultrasound-guided intra-articular injection as an alternative to surgery is the most favourable option, helping preserve the survival rate over a 4-year period, of approximately 1 in 100 patients considered candidates for THR, preserve work capacity for a total differential amount of 500 days, and achieve considerable savings in economic terms, of approximately 550,000 € and 600,000€ euros from the NHS and the Societal perspectives, respectively
Venous tromboembolism treatment: budget impact analysis of rivaroxaban in Italy
Full text linkBACKGROUND: Venous thromboembolism (VTE) is frequently leading to severe complications, particularly deep vein thrombosis (DVT) and pulmonary embolism (PE), and requires high cost healthcare intevention. Rivaroxaban, a novel oral factor Xa inhibitor approved for treatment of DVT, PE and reduction of the risk of recurrence, may represent a cost‑effective anticoagulant choice.OBJECTIVE: This study aims to evaluate the economic impact of the use of rivaroxaban for preventing DVT and PE in Italy.METHODS: We conducted a budget impact analysis to estimate clinical outcomes and economic consequences associated to rivaroxaban vs. standard therapy (low molecular weight heparin + vitamin K antagonists) in the prevention of DVT and PE, over a three‑year time horizon. In the analysis we performed two hypothesis: complete replacement of LMWH/VKA with rivaroxaban (hypothesis 1) and partial and progressive replacement of LMWH/VKA in the first three years of reimbursement (hypothesis 2). Only direct healthcare costs have been considered.RESULTS: Total replacement of LMWH/VKA with rivaroxaban in DVT and PE is associated to a reduction of recurrent symptomatic thromboembolism, major bleeding, vascular events and mortality, with an expenditure saving of about € 11.3 mln (DVT) and € 6.6 mln (PE), corresponding to an average savings per patient treated with rivaroxaban amounted to € 112.9 and € 123,3, respectively. In hypothesis 2 it is estimated that 22%, 25%, and 27% of DVT patients and 12%, 16%, and 20% of PE patients, would be treated with rivaroxaban over the first three years. This would translate into a total saving on healthcare expenditure of € 8.4 mln for DVT and € 3.2 mln for PE and reduction of length of stay with a slight increase in pharmaceutical expenditure.CONCLUSIONS: Rivaroxaban provides significant advantages in terms of events avoided and related costs that would result in a reduction in the total expenditure on the Italian NHS
Cost‑effectiveness analysis of apixaban versus other NOACs for the prevention of stroke in Italian atrial fibrillation patients
Full text linkOBJECTIVES: The study evaluated the cost‑effectiveness of apixaban in preventing thromboembolic events in non‑valvular atrial fibrillation (NVAF) patients, as compared to other three available novel oral anticoagulant agents (NOACs), from the Italian Health System (SSN) perspective.METHODS: A previously published lifetime Markov model was adapted for the Italian context. Baseline clinical risks were assigned based on the demographic and clinical features of the patients; effectiveness and safety parameters derived from adjusted indirect comparison using warfarin as link. The main clinical events considered in the model are 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 clinical risks and weighted by published utilities. Unit costs were collected from published Italian sources and actualized to 2013. Costs and health gains occurring 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 (DSA&PSA) were carried out.RESULTS: In the short to medium term, apixaban was associated with marginal LYs and QALYs gains and slight savings, as compared to other NOACs. However, as apixaban extended expected survival versus dabigatran (110mg), dabigatran (150mg) and rivaroxaban (0.13, 0.08, and 0.06 LYs or 0.11, 0.07, and 0.05 QALYs), expected total lifetime costs exceeded those of these comparators (€ 319, € 282, and € 16). Corresponding ICERs were estimated in € 2,911, € 3,882 and € 327 per QALY gained. The most influential parameter according to DSA was daily costs of NOACs, but the corresponding ICERs remained well below commonly accepted WTP values. In PSA, the probabilities of apixaban being cost effective with a WTP threshold of 20,000 €/QALY gained were 99%, 92% and 93% for the same comparisons.CONCLUSIONS: Apixaban is expected to be more effective than dabigatran and rivaroxaban in Italian NVAF population, and marginally more costly due to consume healthcare resources for a longer period of time. The ICERs have a high likelihood of being below conventional thresholds of WTP for health benefits of the SSN and suggest that apixaban is cost‑effective compared with other three available NOACs
GOLD guidelines adherence impact on the NHS budget
Full text linkOBJECTIVE: Aim of this study was the evaluation of the adherence level to GOLD guidelines for the COPD patients’ treatment in the Italian GPs setting, observing the time trend on ICS therapies’ pharmacoutilization, specifically in mild and moderate COPD patients, which is considered inappropriate by GOLD guidelines. Moreover, a pharmacoeconomic analysis has been implemented in order to evaluate the economical burden of the improper management of COPD.METHODS: The retrospective GPs database study has analyzed patients with at least one diagnosis of COPD during the periods January 2005 – December 2008 (Cohort 1) and January 2009 – December 2011 (Cohort 2), who had a reported value of VEMS, at least one prescription of a drug from ATC R03 class within two months from the date of spirometric exam and aged 40 or more. Disease severity has been defined according to 2008 GOLD guidelines. Comparison between the cohorts has been implemented to verify possible variations in guideline adherence. Furthermore, an economical analysis has been developed in order to highlight saves obtained by following GOLD guidelines and the total inappropriate therapies’ costs.RESULTS: The first cohort involved 2,103 COPD patients, while the second cohort included 1,647 subjects. Reduction of ICS therapies has been shown between the two cohorts, with a decrease of 8.4% for mild patient and 1.6% for moderate patients; considering all the disease severities, the reduction was about 4%. Pharmacoeconomic analysis on mild and moderate patients has pointed out that about 50% of the total ICS treatments (814,692 € on 1,658,164 €) is related to the ICS element, and so considered inappropriate costs.CONCLUSION: Economic differences between the two periods have highlighted a minor mean costs for Cohort 2, underlining an improvement in the adherence to the GOLD guidelines in the last period
Real‑life cost and cost‑effectiveness for tiotropium 18 μg od monotherapy in moderate and severe COPD patients: a 48‑month survey
Full text linkBACKGROUND: Tiotropium monotherapy enables a significant minimization of morbidity in COPD. OBJECTIVE: to evaluate and compare cost and cost‑effectiveness of tiotropium monotherapy administrated for 24 months (18 μg od) in mild‑to‑moderate and severe chronic obstructive pulmonary disease (COPD). METHODS: Clinical outcomes (days in hospital; visits in general ward; cycles of systemic steroids; cycles of antibiotics and maintenance therapy drugs) were evaluated in two groups of patients corresponding to predicted FEV1 baseline values ≤ 50% (A) and > 50% (B) from the Italian NHS perspective. In order to perform cost‑effectiveness analysis, FEV1 value, available for each patient, was converted in SGRQ score using a published multivariate linear model. Utilities were then obtained through the Ståhl equation. RESULTS: The comparison between 24 months of standard therapy and subsequent 24‑month period of tiotropium monotherapy showed that hospitalization cost, which represents the driving treatment cost, drops from 77% to 69% (A) and from 67% to 33% (B) of the total cost. Differently, maintenance therapy cost increased but the amount was more than offset by the savings accruing from the shortening of hospitalization. Furthermore, cost‑effectiveness results revealed a mean savings of about 216 € (A) and 961 € (B) other than a mean gain of 0.07 QALY (A) and 0.02 QALY (B). Dominance of tiotropium (calculated only within patients completing treatment course) revealed that in almost 29% (A) and 36% (B) of subjects tiotropium strategy is dominant while only in 2% (A) and 7% (B) of cases is associated to costs increment and worsening on quality of life. The dominance was systematic in severe COPD. Statistical analyses confirm such trend. CONCLUSIONS: Results of the present study suggest that tiotropium used as unique treatment in COPD systematically consents significant costs savings together with positive effects on evaluated quality. These effects prove proportional to COPD severity.
Experiences of including costs of added life years in health economic evaluations in Sweden
Full text linkIt is of importance to include the appropriate costs and outcomes when evaluating a health intervention. Sweden is the only country where the national guidelines of decisions on reimbursement explicitly state that costs of added life years should be accounted for when presenting health economic evaluations. The aim of this article is to, from a theoretical and empirical point of view, critically analyze the Swedish recommendations used by the Dental and Pharmaceutical Benefits Agency (TLV), when it comes to the use of costs of added life years in economic evaluations of health care. The aim is furthermore to analyze the numbers used in Sweden and discuss their impact on the incremental cost‑effectiveness ratios of assessed technologies. If following a societal perspective, based on welfare economics, there is strong support for the inclusion of costs of added life years in health economic evaluations. These costs have a large impact on the results. However this fact may be in conflict with ethical concerns of allocation of health care resources, such as favoring the younger part of the population over the older. It is important that the estimates of production and consumption reflect the true societal values, which is not the case with the values used in Sweden
Budget impact analysis of apixaban versus other NOACs for the prevention of stroke in Italian atrial fibrillation patients
Full text linkOBJECTIVE: This study aims to perform a budget impact analysis of the use of three available novel oral anticoagulant agents (NOACs) for preventing thromboembolic events in Italian patients with non‑valvular atrial fibrillation (NVAF).METHODS: Estimated Italian population of patients was run through a previously published lifetime decision tree/Markov model simulating their treatment with the available therapeutic options: dabigatran at two dose levels (110 mg/bid for the over 80 years old, 150 mg/bid for younger NVAF patients), rivaroxaban (20 mg/uid), and apixaban (5 mg/bid). Effectiveness and safety estimates derive from an adjusted indirect treatment comparison using warfarin as link. The main clinical events considered in the model are ischemic and hemorrhagic stroke, systemic thromboembolism, bleeds (both major and clinically relevant minor) and cardiovascular hospitalizations, besides treatment discontinuations. Epidemiological data and unit costs, actualized to 2013, are collected from Italian published sources. The budget impact analysis evaluates the financial impact of apixaban introduction by comparing expected 1,2, and 3 years costs in hypothetical scenarios: with and without apixaban. Italian NVAF patient population estimation is based on official apixaban reimbursement criteria, applying the characteristics of the trial population to national epidemiologic data. Numbers of patients for each regimen are estimated by projecting share evolution. Sensitivity analysis is performed on an alternative non‑experimental population of NVAF patients.RESULTS: Among available NOACs, apixaban was expected to be the least expensive in an estimated patient population of 364,000 Italian patients, allowing for savings of € 1,180,549, € 3,841,429 and € 5,368,918 at 1,2, and 3 years, respectively. Results of the simulation run on an alternative non‑experimental population of NVAF patients yields comparable estimates.CONCLUSIONS: The different safety and effectiveness profiles of the three available NOACs emerging from the adjusted indirect comparison indicate that apixaban could improve health care expenditure control while maintaining or increasing therapeutic appropriateness in the Italian NVAF population
Cost-effectiveness of tenofovir in the treatment of patients with chronic hepatitis B: data from literature
Full text linkChronic hepatitis B (CHB) is a complex disease with significant social impact both on the patients’ quality of life of and the economic resources involved. Its chronicity affects considerably not only the clinical management of the disease (for the need for drugs with proven long-term safety and low rate of resistance), but also the economic impact (for the high costs of treatment, the management of complications, and the constant monitoring of therapy).Since, as is well known, the main problem of modern health care systems is the general scarcity of available resources in the face of growing demand for health, the issue of economic evaluation of therapies for the treatment of chronic hepatitis B has been addressed in numerous national and international studies. In fact, clinicians find a strong support for the choice of the most suitable therapeutic pathway in the major scientific societies’ guidelines (European Association for the Study of The Liver – EASL, American Association for the Study of Liver Diseases – AASLD, Associazione Italiana per lo Studio del Fegato – AISF), while the analysis of the economic implications is rather more difficult, even for the methodological differences and peculiarities of the different countries.The aim of this paper is to present a brief summary of some of the recently conducted cost-effectiveness analyses and extrapolate some data to support the economic evidence related to the treatment of CHB with nucleos(t)ide analogs. In particular, the article focuses on the comparison between entecavir (ETV) and tenofovir (TDF), the two oral antiviral therapies recommended for first-line treatment. In the selected studies, the comparison between the different treatment options was conducted in order to assess the incremental cost-effectiveness ratio (ICER) and the results were expressed in terms of QALYs (Quality Adjusted Life Years) gained.Despite the methodological differences among the selected studies, tenofovir is found to be, in the context of first-line oral antiviral therapies, the most cost-effective treatment for patients with chronic hepatitis B