Farmeconomia. Health economics and therapeutic pathways
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Taxane therapy in the adjuvant treatment of breast cancer in Italy: economic evaluation
No full textBreast cancer (BC) is one of the leading cause of death in developed Countries and every year more than a million new cases are diagnosed worldwide. In Italy the prevalence of BC was estimated to be 1,070 per 100,000 at 31 December 1992. Nevertheless, despite the increase in incidence, mortality rate for BC are decreased in the last decades probably due to several factors such as implementation of screening programs, early diagnosis and new adjuvant therapies. Important types of adjuvant chemotherapy include anthracyclines and taxanes and these treatments continue to be evaluated to determine optimal combinations and dosing regimens. The efficacy of paclitaxel and docetaxel in adjuvant setting for the treatment of early BC has been assessed in different trials where the two taxanes showed a significant increase in both Disease Free Survival (DFS) and Overall Survival (OS) in comparison with nontaxane therapy. In particular results from one of the last studies comparing paclitaxel and docetaxel show equivalent efficacy for both drugs. At the light of the recent findings, the objective of this work is to perform a cost minimization analysis of paclitaxel vs docetaxel in the adjuvant setting for treatment of early BC in Italy. The analysis was conducted from the National Health Service’s point of view, assuming equivalent efficacy in terms of DFS and OS for both taxanes. Costs were evaluated on the basis of therapeutic schemes used in the analyzed trials. Results show that paclitaxel, administered every 3 weeks for 4 cycles after doxorubicin and cyclophosphamide, represents the less costly therapy. This is a conservative costs estimate based on data from literature that does not take into account possible additional costs associated to the treatment of febrile neutropenia (FN) as adverse event related to chemotherapy. Since, on the basis of scientific literature data, FN seems to be more related with docetaxel than with paclitaxel administration, it is likely that in clinical practice the Growth–Colony Stimulating Factor is often prescribed as a preventive therapy when Docetaxel is administred, giving rise to treatment costs
Economic evaluation of the CARDS study
No full textIntroduction: 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
Terapia del dolore: nuove norme e aspetti pratici per l’uso degli analgesici
Get PDFUntil recently, pain therapy in Italy was conducted with largely sub-optimal standards, as revealed by one of the lowest mean morphine consumption values, an important indicator of pain therapy quality according to the WHO, among industrialized countries. The recognition of such a negative situation has led to an important effort to improvement, carried out by the law-maker, institutions and health professionals. As suggested by the WHO, these efforts aimed at three main objectives: reducing the cultural barriers to appropriate opioid use through targeted education and information, easing of analgesic drug prescription and availability, and improvement of the integration among hospital-based and domiciliar pain management and care-giving. In this article, the new legal framework concerning the prescription and administration of analgesics - regulatory innovations started in February 2001 - is presented and its practical implications for health professionals are discussed. Alongside the new laws, some regulatory interventions recently adopted by the Italian Drug Agency (AIFA) are presented and discussed, as they share the proposition of simplifying pain therapy and permit the prescription of more analgesics paid for by the National Health Service. In the last years, the premises for a more rational and modern approach to pain therapy in Italy have been created, which will need to be followed by cultural, organizing and clinical practice adaptations in order to warrant effective and efficient management of algic patients
Valutazione farmacoeconomica della prevenzione con picotamide vs acido acetilsalicilico dei pazienti diabetici con vasculopatia periferica
Get PDFType 2 diabetes mellitus (DM) and peripheral arterial disease (PAD) are two very relevant cardiovascular (CV) risk factors, which can often be found concurrently in the same patient. The DAVID trial, a double-blind, randomized, aspirin(ASA)-controlled study, has demonstrated that the use of picotamide, a thromboxane A2 synthase and receptor dual inhibitor, is associated with lesser CV morbidity and mortality in this type of patients in comparison to ASA, considered the standard antiplatelet agent. In order to estimate clinical and economic impacts of picotamide in the Italian health care setting, we developed a pharmacoeconomic model based on clinical data from DAVID and national economic parameters and demographics. The base case scenario, which reflects current prices and reimbursement policy (i.e. ASA fully paid for, picotamide out-of-pocket for patients) yielded an incremental cost/effectiveness ratio (ICER) of about 8,500 euro/year of life (YOL) saved, which falls below conventionally adopted willingness to pay thresholds. This cost, however, is totally born by the patient, while the savings on health care expenditures for avoided events (and less ASA) benefit the national health service (NHS). These results may help the physician in explaining the consequences of this choice to his/her patients, facilitating a fully-informed choice. The availability of a theoretical model allowed to explore some alternative scenarios, that indicate that the ICER can be further lowered and the economical burden better distributed through policy changes. In conclusion, the pharmacoeconomic model indicated that picotamide is likely to be a cost/effective option for CV mortality and morbidity prevention in patients with concurrent type 2 DM and PAD and that the level of adoption of this strategy will depend on willingness to pay and policy priorities of the NHS and patients themselves
Influenza del trattamento della schizofrenia con neurolettici tipici o olanzapina sui costi sanitari e sugli outcomes lavorativi
Get PDFThe aim of the present study was to evaluate the global treatment cost of schizophrenia with olanzapine or typical neuroleptics, according to Local Health Care Unit point of view. This analysis was performed through naturalistic observation of a cohort of schizophrenic patients referring to Ascoli Piceno ASL Department of Mental Health during 4 years (2001-2004). During year 2003, investigators have identified a cohort of patients who were undergoing treatment switch from typical neuroleptics to olanzapine. These patients, after the switch, are observed prospectively for the next 2 years and retrospectively for the last 2 years of treament. This method allow us to collect data about 4 years of treatment: 2 years of typical neuroleptic treatment followed by 2 years of olanzapine treatment. The present work is presenting the analysis of the first 3 years of observation. The results of our analysis are demonstrating that olanzapine treatment, through a better patient-physician alliance and with rehabilitative activities, allow lower total medical costs for the treatment of schizophrenia than typical neuroleptics. The higher acquisition cost of olanzapine versus typical neuroleptics was compensated by less hospitalizations and territorial medical interventions. During olanzapine treatment patients followed more rehabilitative activities (+71,26%,
Analisi costi-efficacia di 90Y-ibritumomab tiuxetano (Zevalin®) vs. terapie attualmente disponibili nel trattamento dei pazienti affetti da Linfoma Non-Hodgkin (LNH) refrattario o recidivato
Get PDFThe aim of the paper is to compare Italian healthcare-related costs and effectiveness of 90Y-ibritumomab tiuxetan (Zevalin®) vs. currently available II and III line therapies (chemotherapy; radiotherapy; stem cell transplant) for relapsing or refractory Non-Hodgkin Lymphoma (NHL). A cost-effectiveness analysis was performed from Italian National Healthcare Service (INHS) perspective. Clinical, epidemiological and healthcare-related resource consumption data were collected from four independent sources: three clinical databases created in Canada, The Netherlands and United Kingdom (currently available III line therapies) and one published clinical trial (90Y-ibritumomab tiuxetan); further inpatient and outpatient healthcare-related resource consumption data were provided by a Dutch costing study. Inpatient and outpatient healthcare-related procedures were evaluated according to INHS tariffs, provided that 90Y-ibritumomab tiuxetan was administered in day-hospital setting. Whenever not included in INHS tariffs, drugs were mainly costed according to Italian National Therapeutic Formulary. Costs are expressed in euro 2005. Per patient cost for 90Y-ibritumomab tiuxetan equals 17,424.84 euro, whereas the average per patient cost for currently available II and III line therapies reaches 6,870.93 euro (95% CI: 533.67-13,208.19 euro). As far as effectiveness is concerned, 90Y-ibritumomab tiuxetan performs better than currently available II and III line therapies both in terms of average and median therapy-free survival (+ 0.34 years and + 0.38 years, respectively); both the differences reach statistical significance (
Forme galeniche e qualità di vita: il caso di tramadolo
Get PDFTramadol is a weak opioid analgesic used for moderate to severe pain control in acute and chronic diseases. Two new formulations of tramadol are recently admitted for marketing: once-daily (OD) controlled-release and fast-release orodispersible tablets. OD tramadol with its special lipophilic matrix permits to prolong drug effect up to 24 hours with a steady-state bioavailability comparable to that of immediate-release formulations. The efficacy and safety of this formulation of tramadol was evaluated in several trials on patients with moderate to severe chronic pain from osteoarthritis. These studies show similar effect of OD tramadol compared to standard formulation in pain control, quality of sleep, physical and mental functions, dropouts due to insufficient therapeutic effect and adverse events. Specially in the elderly and in chronic pain patients, frequency and complexity of dosing regimen remarkably affects quality of life. Furthermore, several studies show that a high number of daily administrations is one of the main factors that reduce patient compliance. For these reasons, OD tablets of tramadol seem to improve quality of life and acceptability of the therapy. Tramadol orodispersible tablets are useful for acute pain control, in the titration phase and for breakthrough pain control in chronic diseases. The manifacturing process of this formulation allows for rapid disintegration (20-30 seconds), once placed into the mouth, secondary to contact with salivary enzymes. This property facilitates its administration (in every place, without need of water), primarily for people with difficulty in swallowing tablets. Furthermore, respect to drops, it decreases the risk of misdosage. A open, randomized crossover study shows that, even although the galenics of tramadol in orodispersible and conventional fast-release capsules are different, they are bioequivalent and have similar pharmacokinetic parameters
Analisi Costo-Efficacia di Amfotericina B Liposomiale (L-AmB) versus Amfotericina B Complesso Lipidico (ABLC) nel trattamento empirico della neutropenia febbrile
Get PDFCurrent international guidelines for the management of immuno-compromised patients with febrile neutropenia recommend a systemic antimicrobial therapy if fever hasn’t receded after three days of antibiotic treatment. Amphotericin B remains the gold standard because of its broad spectrum fungicidal action and minimal resistance development risk. Nonetheless, therapeutic use of the standard formulation, Amphotericin B deoxycholate, is limited by its toxicity, especially on the kidneys. To counteract this, amphotericin B has been encapsulated in liposomes, a process which reduces its toxicity and allows higher doses to be given. Three lipid formulations have been developed and are now available in most countries: amB colloidal dispersion (ABCD), amB lipid complex (ABLC), and liposomal amB (L-AmB). These lipid formulations differ in pharmacodynamics and pharmacokinetics, and can’t therefore be considered interchangeable. Besides, they are more expensive than Amphotericin B deoxycholate. Aim of the study is to perform a cost/effectiveness analysis (CEA) comparing L-AmB (3mg/kg/die or 5mg/kg/ die) and ABLC (5mg/kg/die) as first-line antimicrobial empirical treatments in immuno-compromised patients with febrile neutropenia resistant to broad spectrum antibiotics. Secondly, we present a cost-minimization analysis (CMA) of the considered alternatives, assuming the same efficacy for all treatments. At the end we value the principal cost items from the point of view of the Italian Health Service, with a particular focus on the economic burden caused by adverse reactions
Pregabalin versus gabapentin nel trattamento dei pazienti con neuropatia periferica: adattamento di un modello internazionale per la valutazione di costo/efficacia e costo/utilità alla realtà nazionale
Get PDFOBJECTIVE: To compare the economic impact of treating neuropathic pain with pregabalin versus gabapentin. DESIGN: A cost effectiveness analysis comparing costs and effects of pregabalin 375 mg/die versus gabapentin 1800 mg/die in the perspective of the Italian National Healthcare Service was developed. The cost effectiveness analysis is examined alternatively in terms of the incremental cost per additional day with no or mild pain, and the incremental cost per quality-adjusted life-year (QALY) gained. Effects were derived from a pregabalin randomised clinical study 1008-155 and gabapentin 645-210 and 945-211 studies. Effects are expressed as reduction score of the VAS pain scale. Pharmacological costs were quantified according to the Italian market price of the drugs; healthcare procedure and hospitalisation costs were quantified on the basis of the National Tariff. Other healthcare services consumption data were derived from a Delphi Panel. To estimate the impact of pregabalin and gabapentin on daily pain experience in patients with neuropatic pain a Markov model is used. The dynamic simulation focuses on a hypothetical cohort of 1000 patients and simulates their daily pain experience over 12 weeks, to estimate clinical and economic outcomes for the group as a whole. MAIN OUTCOME MEASURES AND RESULTS: The cost-effectiveness ratio for the use of pregabalin is less than 1 euro per additional day with no or mild pain and 468 euros per QALY. The sensitivity analysis conducted to examine the effects of decreasing gabapentin dose to 1200 mg/die showes the consistency of the model results. CONCLUSIONS AND RESULTS: Although pregabalin pure costs are higher than gabapentin costs, the analyses prove pregabalin to be more effective with a small additional cost per day with no or mild pain
I farmaci per lo scompenso cardiaco: criteri di scelta razionale e costo-efficace
Get PDFChronic heart failure (CHF) is the final phase of many common cardiovascular diseases. Consequently, it represents a frequent clinical condition: it’s estimated that in developed countries, Italy included, its prevalence exceeds 3%. CHF is also burdensome from an economical point of view, as it absorbs more than 2% of the Italian total health care budget. The main cost driver in CHF, accounting for approximately two thirds of its total expense, is represented by hospital admissions for relapse. The most frequent reason for relapse, in turn, is inadequate treatment, intended both as low patient compliance to prescribed drug regimens and as inappropriate prescribing. Evidence-based guidelines for the optimal pharmacological treatment of CHF have been developed and are constantly updated, and it’s demonstrated that the stricter the adherence to these recommendations, the better the clinical and economic outcomes. Pharmacoeconomic studies conducted on the use of ACE-inhibitors and beta-blockers, in particular, have shown that correct therapeutic strategies can be cost-saving in CHF management, besides providing important clinical benefits. The expansion of generic drug market has brought by a reduction in pharmaceutical prices, allowing to offer the benefits of these highly effective, and cost-effective, treatments for CHF to a larger number of patients, without increasing the global pharmaceutical expense, but probably reducing the total economical burden of the disease