Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy (original) (raw)
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Budget impact analysis of the use of lapatinib in the treatment of breast cancer in Italy
Farmeconomia. Health economics and therapeutic pathways, 2009
Objective: to estimate the impact of lapatinib utilization within the Italian National Health Service (NHS) resources consumption. Lapatinib is an oral inhibitor of kinase protein, approved as dual therapy with capecitabine for the treatment of metastatic breast cancer patients with HER2 overexpression who experience disease progression despite trastuzumab treatment. Methods: the analysis is based on a model, which structure can be summarized as follows: a) national cancer registries-based estimate of the yearly number of HER2+ breast cancer patients who develop metastatic disease in Italy; b) literature-based identification of the rate of patients eligible to receive lapatinib; c) identification of the current therapeutic strategy-mix; d) costing of the alternatives, and e) calculation of budget impact. Direct NHS costs (drug acquisition and administration, and monitoring for 8 cycles of 21 days) are estimated based on current Italian prices and tariffs. Results: the annual number ...
[Budget impact analysis of empagliflozin for the treatment of type 2 diabetes in Italy]
Farmeconomia. Health economics and therapeutic pathways, 2016
BACKGROUND: Empagliflozin is the most recent molecule in the SGLT-2i class, new antidiabetic drugs that reduce renal glucose absorption by determining the excretion in the urine. The high prevalence of T2D, the chronicity of the condition and the severe economic and social burden caused by the disease, impose the need for a careful health economic assessment on each therapeutic innovation in this area. AIM: The aim of this study was to assess the budget impact of adopting empagliflozin in the diabetic population currently treated with sulfonylureas and potentially eligible for treatment with SGLT-2i. METHODS: The budget impact analysis was conducted from the perspective of the Italian National Health Service over a period of three years, through an analytic model developed in MS Excel. The target population was estimated in about 170,000 patients currently treated with sulfonylureas, based on the growth forecasts of the Italian population, epidemiological estimates and drug-use information available in the literature on diabetes in Italy. In the base case was assumed a replacement rate of sulfonylureas equal to 10%, 20% and 30% respectively at the first, second and third year of analysis. A scenario analysis was considered assuming a constant uptake of 100% since the first year. The following direct healthcare costs were considered: 1) acquisition of antidiabetic drugs as the main therapy and as rescue therapy; 2) self-monitoring of blood glucose; 3) management of severe hypoglycemic events and 4) management of major cardiovascular events. Clinical effectiveness data was based on the published literature and unit costs were derived from current prices and tariffs. Oneway sensitivity analysis was developed to assess the impact of input's uncertainty on the overall result. RESULTS: The base case analysis presented a substantially neutral impact on the budget. The 3-year cumulative impact was-454.337 €, corresponding to a 0.1% saving. This means that the replacement of sulphonylureas with empagliflozin determines an increase in acquisition costs of drugs, which is entirely offset by the reduction in costs of self-monitoring of blood glucose, management of hypoglycemic events and cardiovascular events. The scenario analysis, based on the assumption of a full substitution of sulphonylureas with empagliflozin at the first year, yielded a more enhanced savings. The cumulative impact was-2.269.517 €, corresponding to a 0.6% saving. CONCLUSIONS: The present study shows that the replacement of sulfonylureas (a class of generic products) with empagliflozin, motivated by the advantageous efficacy and safety profile, can take place optimizing healthcare expenditure for the management of DT2.
Budget impact analysis of the use of rituximab in the treatment of rheumatoid arthritis in Italy
Farmeconomia. Health economics and therapeutic pathways, 2009
Objective: a Budget Impact analysis was performed to evaluate cost implications for the Italian National Health Service (NHS) of the introduction of rituximab (RTX) in the treatment of rheumatoid arthritis (RA). Methods: RA patients eligible to treatment with a second-line biologic DMARD (Disease Modifying Antirheumatic Drugs) were identified and quantified and available strategies for their management were explored. Costs associated with the different alternatives were estimated, and the impact on the NHS budget was estimated using a cohort simulation based on a Markov chain with a time horizon of 5 years and 1-year cycles. Seven alternative strategies were analyzed, each of them starting after the failure of a first anti-TNFα: 1) the use of a second and a third anti-TNFα; 2) the use of a second anti-TNFα followed by RTX; 3) the use of a second anti-TNFα followed by abatacept (ABAT); 4) the use of RTX as a second biological line, followed by an anti-TNFα; 5) the use of ABAT as a se...
Venous tromboembolism treatment: budget impact analysis of rivaroxaban in Italy
Farmeconomia. Health economics and therapeutic pathways, 2014
BACKGROUND: 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 direc...
Global & Regional Health Technology Assessment: Italian; Northern Europe and Spanish, 2017
livello di glucosio nel sangue nel DT2 porta nel tempo a gravi danni a cuore, vasi sanguigni, occhi, rene e nervi. Le cause del DT2 sono principalmente l'obesità e l'inattività fisica, e si prevede che nel 2030 la malattia diverrà la settima causa di morte nel mondo (3). Il DT2 viene trattato con dieta, attività fisica, farmaci antidiabetici e somministrazione di insulina, in funzione della progressione della malattia. Empagliflozin è un inibitore specifico e reversibile del cotrasportatore sodio-glucosio di tipo 2 (sodium-glucose cotransporter 2, SGLT2) che ha bassa affinità ma alta capacità di trasportare glucosio. Esso è altamente espresso nel tubulo prossimale renale ed è responsabile del 90% del riassorbimento di glucosio che avviene nel segmento contorto del tubulo prossimale del rene (il restante 10% è riassorbito dagli SGLT1 nel segmento rettilineo del tubulo prossimale). Questo meccanismo di riassorbimento del glucosio è alterato nel paziente con DT2. Il co-trasportatore SGLT2, infatti, è sovraespresso a livello renale nei pazienti con DT2 rispetto ai soggetti senza diabete, e anche la sua attività di riassorbimento del glucosio è aumentata. Questo determina nei pazienti con DT2 e iperglicemia un aumento della quantità di glucosio che
Budget impact analysis of empagliflozin in T2D patients with a previous cardiovascular disease
Global and Regional Health Technology Assessment
livello di glucosio nel sangue nel DT2 porta nel tempo a gravi danni a cuore, vasi sanguigni, occhi, rene e nervi. Le cause del DT2 sono principalmente l'obesità e l'inattività fisica, e si prevede che nel 2030 la malattia diverrà la settima causa di morte nel mondo (3). Il DT2 viene trattato con dieta, attività fisica, farmaci antidiabetici e somministrazione di insulina, in funzione della progressione della malattia. Empagliflozin è un inibitore specifico e reversibile del cotrasportatore sodio-glucosio di tipo 2 (sodium-glucose cotransporter 2, SGLT2) che ha bassa affinità ma alta capacità di trasportare glucosio. Esso è altamente espresso nel tubulo prossimale renale ed è responsabile del 90% del riassorbimento di glucosio che avviene nel segmento contorto del tubulo prossimale del rene (il restante 10% è riassorbito dagli SGLT1 nel segmento rettilineo del tubulo prossimale). Questo meccanismo di riassorbimento del glucosio è alterato nel paziente con DT2. Il co-trasportatore SGLT2, infatti, è sovraespresso a livello renale nei pazienti con DT2 rispetto ai soggetti senza diabete, e anche la sua attività di riassorbimento del glucosio è aumentata. Questo determina nei pazienti con DT2 e iperglicemia un aumento della quantità di glucosio che
Budget impact of rosiglitazone in type 2 diabetes
Farmeconomia. Health economics and therapeutic pathways, 2007
BACKGROUND: in type 2 diabetes, the maintenance of non-diabetic glycaemic levels has been shown to decrease the onset of long term complications and consequently their high management costs. In order to achieve and maintain normal blood glucose levels, lifestyle interventions are highly cost/effective, but require good compliance, strong motivation and efforts by the patients. For this reason, a majority of patients needs to start pharmacological therapy shortly after diagnosis. Rosiglitazone, an insulin-sensitising drug, is indicated for subjects with inadequate glycaemic control both as monotherapy, in those contraindicated to metformin, especially if overweight, and as combination therapy with metformin, sulphanilureas or both. OBJECTIVES: rosiglitazone offers clinical advantages over the alternatives, decreasing and/or postponing the need for insulin treatment. Its high acquisition cost may therefore be totally or partially offset by the reduction in future health care resources consumption, and by short-term practical advantages, such as the decrease in the need for blood glucose monitoring and of adverse events. Aim of this study was to investigate the impact of the use of rosiglitazone in eligible diabetic patients on the National Health System budget. METHODS: for this scope an analytic model was implemented, which pathway may be summarized as follows: a) estimate of the number type 2 diabetes patients living in Italy, grouped according to current therapeutic classes; b) estimate of the number of patients with inadequate glycaemic control for each subgroup; c) identification of patients eligible to rosiglitazone treatment; d) identification of the comparator strategy for each patient subgroup ; e) comparison of costs for each couple of alternative options; f) calculation of budget impact. RESULTS: use of rosiglitazone monotherapy instead of sulphanilurea monotherapy induces a mild costs increase. Combination treatment with rosiglitazone added to metformin-or sulphanilurea-based therapies induces significant cost savings for the National Health System, related to lower resources consumption for glycaemic auto-monitoring and for hypoglycaemic events management, as compared to standard combination therapies. The hypothetical scenario in which all eligible patients are treated with rosiglitazone was estimated to induce net cost savings of about 260 millions Euro per year.
2017
Background: L’obiettivo dell’analisi e stato quello di valutare l’impatto economico dell’introduzione di pasireotide nella prospettiva del Servizio Sanitario Nazionale (SSN). Metodi: I dati epidemiologici e di costo che hanno implementato il modello di budget impact (BI) sono stati ottenuti tramite una revisione sistematica della letteratura. Il BI e stato stimato confrontando uno scenario senza l’introduzione di pasireotide rispetto ad uno scenario con nella prospettiva del SSN. Inoltre, e stata sviluppate una analisi di sensibilita deterministica (DSA) e l’applicazione del metodo payoff. Risultati: Il modello ha stimato un totale di circa 2.314 pazienti acromegalici ad oggi trattati con una seconda linea farmacologica. L’introduzione di pasireotide consente una riduzione complessiva di spesa pari a € 662.095 nei 5 anni di analisi. La DSA ed il valore atteso di pay-off confermano la robustezza dei risultati. Conclusioni: L’introduzione sul mercato di pasireotide non comporta un agg...
Farmeconomia. Health economics and therapeutic pathways, 2008
Objective: to evaluate pharmacoeconomic implications of the use of valsartan, an angiotensin II antagonist in addition to standard therapy for the treatment of chronic congestive heart failure (CHF). Methods: the study was conducted performing cost-utility and budget impact (B.I.) analyses by means of a cohort simulation based on a probabilistic Markov model and projecting 23-months follow-up results in the Val-HeFT trial study over a 10-years time horizon. The model included four states (class NYHA I, II and III and death), and had a cycle of 1 year. Two probabilistic simulations (varying first patients parameters and after model parameters) were performed using WinBUGS, a software for bayesian analysis. The distributions of patients parameters (sex, age, use of ACE inhibitors) corresponding to Val-HeFT inclusion criteria in the simulated population were derived from the Italian CHF patients population. Individual mortality was derived from general mortality by adjusting with a NYHA state-specific HR, and the probability of changing NYHA class from Val-HeFT. Costs were calculated in the perspective of the Italian NHS and account for drugs and CHF hospitalizations. Quality of life weights were obtained by elaborating published HRQoL data of CHF patients. A 3.5% annual discount rate was applied; probabilistic sensitivity analysis was performed on each parameter using original-source 95% CI, or a ±10% range where it was unavailable. Results: in the 10 years horizon, patients were estimated to live an average of 4.4 years or 3.2 QALYs, with slight increases in the valsartan group. In this group, hospitalizations are predicted to be sensitively reduced and overall costs decreased by about 500 €/pz. In subgroup analysis, valsartan loses dominance in NYHAII and ACE-using patients, for which ICURs are 17,330 and 27,000 €/QALY, respectively. B.I. analysis predicts a saving of about 172 millions €. Conclusions: valsartan in addition to standard therapy is predicted to be a cost/effective strategy for Italian patients with mild-to-severe CHF and cost-saving from the perspective of the NHS.
Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia
A 85-year-old man, with CKD (e-GFR 35 mL/min), had been given Dabigatran (a direct thrombin inhibitor) at 110 mg daily dose because of atrial fibrillation. Due to intercurrent diarrhea and dehydration, renal function worsened (e-GFR 11 mL/min) and Dabigatran excretion decreased, thereby inducing drug overload. In this case, Dabigatran must be removed by dialysis, but the most appropriate schedule is still undefined. The effects of both continuous haemodiafiltration (CVVHDF) and intermittent haemodialysis (IHD) on plasma Dabigatran (Echarin Chromogenic Assay) were reported. Dialysis clearance of Dabigatran was reported as ratio to urea clearance (Dab/Urea(Cl)). Coagulation was assessed by both DOA-aPTTratio and Thrombin Time-ratio (TTratio). Dabigatran was elevated at 597 ng/mL predialysis (bleeding threshold being 30 ng/mL), and decreased to 96 ng/mL (-84%) after 20 hours of CVVHDF (Urea(Cl) = 67 mL/min). Dab/Urea(Cl) was 0.49. Three hours after dialysis, Dabigatran rebounded to 208...