Farmeconomia. Health economics and therapeutic pathways
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Theory and practice of the Health Technology Assessment in countries with a predominant public health service
No full textBudget impact analysis of the use of lapatinib in the treatment of breast cancer in Italy
No full textObjective: 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 of patients eligible for lapatinib-based therapy can vary from 1,676 to 2,172, according to the expected extent of the trastuzumab use as adjuvant therapy. The current strategy-mix beyond progression is based on drugs used in the clinical practice, with a portion of patients continuing trastuzumab. Pharmaceutical cost of lapatinib results higher than the average cost of the current pattern of treatments. This cost increase would be partially offset by the reduction of laboratory tests and hospital personnel work for the oral administration of lapatinib, as compared to intravenous strategies. Furthermore, a risk sharing agreement has been adopted by NHS and manufacturer, according to which the NHS pays only for responding patients. As a consequence, lapatinib-based therapy would increase yearly NHS expenditure by about 3.8-4.9 millions of euro. Conclusions: lapatinib is the only treatment option specifically indicated for the management of HER2+, metastatic breast cancer in patients who received prior treatments including trastuzumab and is estimated to induce a low budget impact for the Italian NHS
The clinical and economic value of the dipeptide alanyl-glutamine in total parenteral nutrition of critically ill patients treated in intensive care units in Italy
No full textIntroduction: the supplementation of alanyl-glutamine dipeptide in critically ill patients necessitating total parenteral nutrition (TPN) improves clinical outcomes, reducing mortality, infection rate, and shortening ICU hospital lengths of stay (LOS), as compared to standard TPN regimens. Here we present a pharmacoeconomic evaluation of alanyl-glutamine dipeptide in critically ill patients admitted to Italian Intensive Care Units (ICUs). Methods: a Discrete Event Simulation model that incorporates outcomes rates from 200 Italian ICUs for over 60,000 patients, alanyl-glutamine dipeptide efficacy data synthesized by means of a Bayesian Random-Effects meta-analysis, and national cost data has been developed to evaluated the alternatives from the point of view of the hospital. Simulated clinical outcomes are death and infection rates in ICU, death rate in general ward, and hospital LOSs. One-way and probabilistic sensitivity analyses are performed by varying all uncertain parameter values in a plausible range. Results: alanyl-glutamine dipeptide results more effective and less costly than standard TPN: reduced mortality rate (23.55% ± 15.2% vs 34.50% ± 2.06%), infection rate (15.91% ± 3.95% vs 18.97% ± 3.94%), and hospital LOS (25.47 ± 0.26 vs 26.00 ± 0.27 days) come at a lower total cost per patient (23,922 ± 3,249 vs 24,145 ± 3,361 Euro). Treatment cost is completely offset by savings on ICU and antibiotic costs. The cost/effectiveness acceptability curve indicates an estimated 78% probability of alanyl-glutamine dipeptide resulting dominant and a 90% probability of resulting cost/effective for a willingness to pay up to 1,500 Euro for one patient death avoided. Conclusions: alanyl-glutamine dipeptide is expected to improve clinical outcomes and to do so with a concurrent saving for the hospital
Management of patients with metastatic colorectal cancer: economic consequences of different treatment programs
No full textThe clinical pattern of Metastatic ColoRectal Cancer patients, receiving first-line infusional 5-FU or oral capecitabine (CAP) chemotherapies, was valorized in the perspective of the Italian NHS. A cost-minimization analysis was implemented on the basis of retrospective data from 5 centers. 202 subjects: 126 receiving 5-FU-association, 10 5-FU-monotherapy; 31 CAP-association, 35 CAP-monotherapy. Therapeutic patterns differed as to chemotherapy administration resources consumption: 5-FU was administered in Day Hospital and CAP in the outpatient setting. Mean total cost/patient was in the range of € 6,841 (monotherapy-5-FU)- € 12,620 (association-5-FU) and € 2,056 (monotherapy-CAP)-€ 9,745 (association-CAP). The infusional administration route of 5-FU was the driver of costs
Influence of generics in prescribing dynamics of proton pump inhibitors in general practice
No full textUse of antisecretory drugs has greatly increased in recent years in Italy. After the launching of generic lansoprazole (early 2006), several Italian Regional Health Authorities have introduced measures to favour the prescription of less expensive PPI. The aim of this study is to evaluate general practitioners’ prescription (GPs) of different Proton Pump Inhibitors (PPIs) in the period between 2005 to 2008. Analysis has been performed on a database of 99 medical practitioners that have managed an average of 150,000 inhabitants. We evaluate the PPIs prescriptions from Jan 2005 to Dec 2008. Evaluations performed are the following: 1) PPI prescription (total and separately for lansoprazole, esomeprazole, pantoprazole, rabeprazole, and omeprazole); 2) prevalence of the reimbursement purpose (Gastroprotection – G; Acid-Related Disease – ARD); 3) PPI prescriptions separately for ARD diagnostic codes. Data were expressed as Compound Annual Growth Rate (CAGR). PPI consumption were quantified using Defined Daily Dose system (DDD). The total volume of PPI’s prescribing increased progressively over the 4 years (CAGR +15%). The proportion of defined daily doses accounted for by lansoprazole increased from 12.0% in 2005 to 30.9% in 2008. The prescription of omeprazole decreased from 42.2% to 26.7%, while that of esomeprazole remained costant. The reimbursement purpose was higher for G (CAGR +43%) than for ARD (CAGR +7%). We found an increase of lansoprazole prescriptions especially for heartburn (CAGR +52.4%), gastroesophageal reflux (CAGR 34,5%) and upper abdominal pain (CAGR 37,2%). Generic PPIs has unexpectedly increased the prescription of whole drug class during the period 2005-2008. Our data suggest that the appropriateness of PPI prescription after generic PPI introduction should be carefully monitored to distinguish between cost-effective from cost-ineffective PPI treatment
Pharmacoeconomic evaluation of influenza vaccination programs in elderly in Italy
No full textBackground: influenza infection is an important cause of morbidity and mortality in the elderly population, especially in the presence of underlying disease. Vaccination has proven effective in the reduction of influenza-like illness (ILI) cases and influenza-related hospitalizations, drug consumption, primary care consultations and death. The aim of this study is to assess the economic impact in Italy of different prophylactic strategies (vaccination with a standard vaccine, with the innovative MF59® adjuvated vaccine and no vaccination) comparing their costs and outcomes in the elderly population. Methods: a pharmacoeconomic simulation model to estimate costs and consequences of influenza with the three intervention strategies has been developed. Health economics and demographic data are taken from specific Italian sources, and vaccine effectiveness data are taken from published literature. Direct sanitary costs are considered according to current prices and tariffes. Results: it was estimated that 9,800,000 of the about 12,000,000 people with at least 65 years currently resident in Italy can be considered at high risk for influenza complications because of underlying chronic diseases. Absence of vaccination could lead to more than 2 millions of ILI cases, and 30,000 related deaths. The reduction of cases attainable with the implementation of a vaccination program would lead to an estimated 1.5 million cases with a standard vaccine, and to 1.3 million with a strategy based on the MF59® adjuvated vaccine. The standard vaccination strategy could produce a moderate total cost increase of about € 45,000,000 (+4.3%), whereas the use of the adjuvated vaccine would lead to an estimated saving of about € 80,000,000 (-7.9%), both compared to the null option. Cost savings are mainly related to hospital admissions avoided with the use of vaccines. Incremental cost-effectiveness ratio (ICER) of the standard vaccine versus no vaccination strategy is of € 85.68 for each ILI episode avoided, and of € 4,411.42 for death avoided. The strategy based on the MF59® adjuvated vaccine dominates the other two options. Conclusions: vaccination with the MF59® adjuvated vaccine (Fluad®) results more effective and cost saving when compared with the standard vaccination or the no vaccination, thus representing the strategy of choice for the elderly population. Moreover, the standard vaccine proved to be largely cost effective with respect to the null option
Dabigatran in the prevention of venous thromboembolism after major orthopedic surgery
No full textVenous thromboembolism (VTE) is a very frequent surgical complication, especially in major orthopedic procedures. Prophylaxis with pharmacological agents, including warfarin and subcutaneous injection of either low-molecular weight heparin (LMWH) or low-dose unfractionated heparin, and/or with mechanical methods has been shown to be effective and safe. Despite recommendations on the routine implementation of these prophylaxis methods, some surveys demonstrate that many patients currently don’t receive any prophylaxis. The recent introduction of dabigatran etexilate, a novel oral direct thrombin inhibitor approved for VTE prophylaxis in total knee and hip substitution, represents a major advance in the provision of efficient anticoagulation therapy. Two pivotal randomized controlled multicenter trials assessed non-inferiority of dabigatran 150/220 mg/day versus enoxaparin 40 mg/day in the prevention of VTE after hip and knee replacement. From an economical point of view, an English modeling study on dabigatran cost/effectiveness showed it to be associated with lower cost and slightly higher gain in Quality Adjusted Life Years, thus dominating enoxaparin. Other analyses obtained results consistent with these, estimating inferior costs related to the use of dabigatran with respect to low weight heparin; this difference was mainly due to health personnel work for heparins subcutaneous administration. In Italy, acquisition costs for a 28-35 days therapeutic cycle of main antithrombotic drugs vary between 70 and 170 €, according to different distribution policy. Dabigatran, with a cost of 117 €, holds a medial position. Cost savings related to oral administration may partially offset the price difference between dabigatran and the less expensive options among LMWHs or, compared with the more expensive ones, add to pharmaceutical cost savings. In order to increase the effectiveness of VTE prophylaxis, the improvement of patient adherence to the prescribed strategy is needed. On this plane, dabigatran may be associated to some advantages, like the lack of drug and food interactions, the need for less frequent coagulation monitoring compared to vitamin K antagonists, and obviation of daily injections of parenteral agents. In conclusion, these considerations suggest that dabigatran may prove an interesting alternative in VTE prevention in orthopedic surgery
Marche
Get PDFIn Marche region 65,7% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 26 cases of cervicocarcinoma and 11 related deaths and thus results to be cost-effective (21.677 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 25 cancer cases and 11 deaths could be prevented, with a very similar cost-effectiveness ratio. In Marche region, the net cost for woman vaccinated is 155 € for the single cohort and 158 € for the multiple cohort
Daptomycin (Cubicin) in patients with complicated skin or soft-tissue infections
Get PDFSkin and soft-tissue infections (SSTIs) are commonly observed and differ in terms of site and localization, clinical characteristics, and the aetiological agent; these infections are usually caused by Staphylococcus aureus or beta-haemolytic streptococci, and are the most frequent forms of methicillin-resistant S. aureus (MRSA) infections. SSTIs are considered complicated if they involve deeper skin structures (fascia or muscle layers), require significant surgical intervention or arise in the presence of significant co-morbidity. The progressive increase of bacterial resistance, in particular for Gram-positive bacteria infections, to currently used agents is a serious and growing problem, and in particular MRSA, GISA (glycopeptides-insusceptible S. aureus), VRE and GRE (glycopeptides-resistant enterococci) are of concern. There is, therefore, a need for additional agents active against these difficult-to-treat pathogens