Oral antiviral therapies are cost-effective vs. no treatment but indirect comparisons should be avoided

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Valutazione economica dello studio AVERT

Introduction: the AVERT study (“Aggressive lipid-lowering therapy compared with angioplasty in stable coronary artery disease”) compared aggressive cholesterol-lowering (with the statin atorvastatin) to angioplasty in patients with mild to moderate coronary artery disease. Aim: our aim was to investigate the economic consequence of high dose of atorvastatin vs percutaneous coronary revascularization followed by standard therapy in Italian patients with stable coronary artery disease Methods: clinical information were taken from the AVERT study. We conducted a cost-effectiveness analysis, comparing high dose of atorvastatin (80 mg/die) versus angioplasty in the perspective of the Italian National Health Service. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of mortality and morbidity reduction (number of deaths, life years gained and frequency of hospitalizations). We considered an observation period of 18 months. The costs borne after the first 12 months were discounted using an annual rate of 3%. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. We also conducted a threshold analysis. Results: the cost of atorvastatin therapy or angioplasty over the 18 months period amounted to approximately 779 euro and 5.5 millions euro per 1,000 patients respectively. Atorvastatin was more efficacious compared to angioplasty and the overall cost of care per 1,000 patients over 18 months of follow-up was estimated at 1.8 millions euro in the atorvastatin group and 7.2 millions euro in the angioplasty group, resulting into a cost saving of 5.4 millions euro that is 74,9% of total costs occurred in the angioplasty group. Discussion: this study demonstrates that high does atorvastatin treatment leads to a reduction of direct costs for the National Health System if compared to angioplastic treatment. Atorvastatin therapy is dominant since it is both less costly and more effective than angioplasty. Results of sensitivity analysis showed that atorvastatin therapy remains dominant even in the most unfavourable hypotheses

Valutazione economica dello studio MIRACL

Introduction: the MIRACL study (“Effects of atorvastatin on early recurrent ischemic events in acute coronary syndrome”) has evaluated the effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes. It has demonstrated that, for patients with acute coronary syndrome, lipid-lowering therapy with atorvastatin (80 mg/die) reduces recurrent ischemic events in the first 16 weeks, mostly recurrent symptomatic ischemia requiring rehospitalization. Aim: the goal of this pharmacoeconomic study is to evaluate the MIRACL study in the Italian context. Methods: the analysis is based on clinical outcome data from the MIRACL study. Clinical outcomes measured in the study include: death, cardiac arrest, nonfatal myocardial infarction (MI), fatal MI, angina pectoris, stroke, congestive heart failure (CHF), and surgical or percutaneous coronary revascularizations. Economic evaluation was carried out conducting a cost/effectiveness analysis, comparing economic and clinical consequences of high doses atorvastatin (80 mg) vs placebo in patients with unstable angina or acute myocardial infarction. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of mortality and morbidity reduction (number of deaths, life years gained and frequency of hospitalizations). All direct medical costs were taken from the perspective of the Italian National Health System during a 16-week period. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. We also conducted a threshold analysis. Results: the cost of atorvastatin therapy over the 16 weeks period amounted to approximately 162,489 euro per 1,000 patients. The total cost of atorvastatin high dose was about 2.2 millions euro, the incremental cost per patient free from event is 6,601 euro. Discussion: This evaluation found that atorvastatin therapy is cost-effective. Sensitivity analysis shows that cost consequences parameters are substantially sensitive to fluctuation

Valutazione economica dello studio CARDS

Introduction: cardiovascular diseases (CVD) are the major component of premature mortality, generate disability and are a relevant source of cost. The growing incidence of CVD is associated with lifestyle and other modifiable risk factors. Prevention and preclinical detection of CVD reduce morbidity and mortality. Type 2 diabetes is associated with a substantially increased risk of cardiovascular disease. Objective: the aim of the study was to evaluate the health economic consequence of medical therapy with atorvastatin for primary prevention of major cardiovascular events in patients with type 2 diabetes in Italy. Materials and method: in order to reach our objective we drew clinical information from the CARDS study. This economic evaluation was carried out conducting a cost/effectiveness analysis from the perspective of National Health Service (NHS). The analysis was applied to a time horizon in conformity with the observational period adopted in the CARDS study (3.9 years). An incremental cost/effectiveness ratio (ICER) was calculated and is expressed as cost per life years gained (LYG). In order to test the robustness of the results, a one-way sensitivity analysis was performed. Results: the total cost of atorvastatin therapy over 3.9 years amounts to around 1.5 million of euros per 1,000 patients. The total cost of adding atorvastatin to standard care in people treated for primary prevention of major cardiovascular events in type 2 diabetes as those involved in the CARDS study would entail an additional cost of about 1,2 million of euros per 1,000 patients treated per 3.9 years, with an incremental cost/effectiveness ratio (ICER) equivalent to 36,566 euros per patient per LYG. Discussion: the current study is the first economic evaluation of CARDS study to the Italian situation. The results of the current study show that hypolipemic therapy with atorvastatin 10 mg in diabetic individuals is to be considered cost effective

Valutazione economica dello studio CARDS: un aggiornamento

Introduction: in the last decades, prevalence and incidence of type II diabetes mellitus have been rapidly growing worldwide. Most recent projections estimate that the number of people affected by diabetes is destined to double in 2030, producing a significant increase of the healthcare expenditure for the management of complications. Prevention of cardiovascular events in diabetes population represents a priority for decision makers, who have to evaluate the cost-effectiveness of therapeutic interventions. Objective: to provide an updated cost-effectiveness evaluation of treating type II diabetes patients with atorvastatin versus placebo, in the light of the imminent price reduction of atorvastatin due to loss of exclusivity and of other therapeutic and hospital costs. Material and Methods: we derived clinical information from the CARDS study, a randomized, multicenter clinical trial evaluating efficacy of atorvastatin versus placebo in preventing the occurrence of cardiovascular events in a cohort of type II diabetes patients without previous history of coronary events. A cost-effectiveness analysis in the perspective of the National Healthcare System (SSN) has been performed, under the hypothesis of the imminent price reduction of atorvastatin, due to the loss of exclusivity. Results: after a median follow up of 3.9 years, the number of patients with at least a major cardiovascular event requiring hospitalization was lower in the atorvastatin arm (5.8%) compared to the placebo arm (9.0%; p=0.001). Based on a cohort of 1,000 patients, treatment with atorvastatin permitted to gain 29.28 life years. The incremental cost of adding atorvastatin to the standard therapy amounted to €305,682, and was partially balanced by a cost reduction due to fewer hospitalizations, compared to the placebo arm (€ 168,313). Total direct costs were of €602.186 in the atorvastatin group and of € 464,818 in the placebo group, resulting into an incremental cost-effectiveness ratio of € 4,692 for Life Year Gained (LYG). Conclusion: the present study is an update of a previous economic analysis of the CARDS trial. Under the assumed new cost scenario, the cost-effectiveness profile of treating diabetic patients with atorvastatin becomes highly favourable, and leads to a significant reduction of the cost for Life Year Gained compared to the previous findings

Valutazione economica dello studio PROVE-IT

Introduction: the PROVE-IT (“Intensive versus moderate lipid lowering with statins after acute coronary syndromes”) was a comparison of pravastatin 40 mg/die versus atorvastatin 80 mg/die in patients with an acute coronary syndrome (ACS). Aim: our aim was to investigate the economic consequence of high dose of atorvastatin vs usual-dose of pravastatin in Italian patients with a history of acute coronary syndrome. Methods: the analysis is conducted on the basis of clinical outcomes of the PROVE-IT study. We conducted a cost-effectiveness analysis, comparing high dose of atorvastatin (80 mg/die) versus usual-dose of pravastatin (40 mg/die) in the perspective of the Italian National Health Service. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of mortality and morbidity reduction (number of deaths, life years gained and frequency of hospitalizations). We considered an observation period of 24 months. The costs borne after the first 12 months were discounted using an annual rate of 3%. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. We also conducted a threshold analysis. Results: the cost of pravastatin or atorvastatin therapy over the 2 years period amounted to approximately 1.3 millions euro and 870,000 euro per 1,000 patients respectively. Atorvastatin was more efficacious compared to pravastatin and the overall cost of care per 1,000 patients over 24 months of follow-up was estimated at 3.2 millions euro in the pravastatin and 2.5 millions euro in the atorvastatin group, resulting into a cost saving of about 700,000 euro that is 27% of total costs occurred in the pravastatin group. Discussion: this study demonstrates that high does atorvastatin treatment leads to a reduction of direct costs for the National Health System. Atorvastatin therapy is dominant since it is both less costly and more effective than pravastatin. Results of sensitivity analysis showed that atorvastatin therapy remains dominant even in the most unfavourable hypotheses

The burden of renal cell cancer : A retrospective longitudinal study on occurrence, outcomes and cost using an administrative claims database

Abstract Objective To assess the burden of renal cell carcinoma (RCC) in epidemiologic and economic terms. Methods Retrospective, naturalistic longitudinal study on the occurrence, outcomes and cost of RCC using an administrative database. We selected residents of Friuli-Venezia-Giulia (FVG), a North-eastern Region of Italy, who had a RCC first hospital admission during the period 2000–2004, and we followed them up until: 30th June 2005, death or transfers. Direct medical costs were quantified in the perspective of FVG Regional Health Service. Results We enrolled 1358 patients (63% male), the 18.8% presenting a metastatic-stage, leading to a crude incidence of 23/100.000 person-years. During the follow-up, 76% of the metastatic patients and 21% of the non-metastatic patients died. Total health care costs per-patient over the maximum of follow-up were 16,090€ for the localised stage group and 17,656€ in the metastatic-stage group. Discussion RCC imposes a significant epidemiologic and economic burden to the healthcare-system and the society

Valutazioni economiche di atorvastatina in prevenzione secondaria: un aggiornamento

Introduction: cardiovascular diseases are the most common reason of mortality and morbidity in the world, despite therapeutic interventions have improved patients’ prognosis in the last decades. Aggressive lipid lowering treatment with atorvastatin has demonstrated to be effective in preventing the occurrence of new cardiovascular events requiring hospitalizations, in patients previously affected by coronary syndromes. However, the increasing costs of managing cardiovascular diseases impose a careful analysis of the economic benefits of these therapies. Objective: to assess the economic sustainability of using atorvastatin for the secondary prevention of cardiovascular events. Material and Methods: we derived clinical information from five randomized, multicenter trials (AVERT, IDEAL, MIRACL, PROVE-IT, TNT) evaluating efficacy and tolerability of high dosage treatment with atorvastatin over control groups in different patient populations and for different follow up periods. A costeffectiveness analysis in the perspective of the NHS has been performed, under the hypothesis of the imminent price reduction of atorvastatin, due to the loss of exclusivity. Results: in trials AVERT, MIRACL, PROVE IT, the treatment with atorvastatin has demonstrated to reduce both cardiovascular events and overall healthcare direct costs, compared to the respective control groups. In trials IDEAL and TNT, the therapy with atorvastatin has resulted to be cost effective, with incremental cost-effectiveness ratio respectively of € 6,310 for avoided event (vs simvastatin 10 mg) and € 9,058 for CV disease free patient (vs atorvastatin 10 mg). Discussion: the present study represents an update of previous cost-effectiveness analyses, which have previously evaluated the economic consequences of using atorvastatin for the secondary prevention of cardiovascular events. The present analysis has proved the economic benefits deriving from the usage of atorvastatin, which is a dominant alternative in the AVERT, MIRACL and PROVE-IT clinical settings, and a cost effective option in the IDEAL and TNT study populations

Adalimumab clinical efficacy is associated with rheumatoid factor and anti-cyclic citrullinated peptide antibody titer reduction: a one-year prospective study

Studies on autoantibody production in patients treated with tumor necrosis factor-α (TNF-α) inhibitors reported contradictory results. We investigated in a prospective study the efficacy of a treatment with human monoclonal anti-TNF-α antibody (adalimumab) in patients with rheumatoid arthritis (RA) and we evaluated the relationship between treatment efficacy and the incidence and titers of disease-associated and non-organ-specific autoantibodies. Fifty-seven patients with RA not responsive to methotrexate and treated with adalimumab were enrolled. Antinuclear, anti-double-stranded(ds)DNA, anti-extractable nuclear antigens, anti-cardiolipin (aCL), anti-β(2 )glycoprotein I (anti-β(2)GPI) autoantibodies, rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) autoantibodies were investigated at baseline and after 6 and 12 months of follow-up. Comparable parameters were evaluated in a further 55 patients treated with methotrexate only. Treatment with adalimumab induced a significant decrease in RF and anti-CCP serum levels, and the decrease in antibody titers correlated with the clinical response to the therapy. A significant induction of antinuclear autoantibodies (ANA) and IgG/IgM anti-dsDNA autoantibodies were also found in 28% and 14.6% patients, respectively, whereas aCL and anti-β(2)GPI autoantibodies were not detected in significant quantities. No association between ANA, anti-dsDNA, aCL and anti-β(2)GPI autoantibodies and clinical manifestations was found. Clinical efficacy of adalimumab is associated with the decrease in RF and anti-CCP serum levels that was detected after 24 weeks and remained stable until the 48th week of treatment. Antinuclear and anti-dsDNA autoantibodies, but not anti-phospholipid autoantibodies, can be induced by adalimumab but to a lower extent than in studies with other anti-TNF blocking agents