Farmeconomia. Health economics and therapeutic pathways
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Il trattamento dei disturbi psicotici con olanzapina, risperidone e neurolettici tipici: una valutazione comparativa di costo/efficacia in una realtà psichiatrica locale
Get PDFBACKGROUND: Several clinical trials demonstrated that atypical antipsychotics are more effective but also more expensive (as drug cost) compared with the typical neuroleptics by treating psychotic disorders. The present study aimed to evaluate this result using an observational approach which better reflects the real clinical practice. OBJECTIVE: To evaluate clinical effectiveness (including work and social functioning) and overall direct costs in a group of patients affected by psychotic disorders (schizophrenia and bipolar) and treated with typical and atypical (olanzapine and risperidone) antipsychotics. METHODS: With a multicentre observational design - two years long - 89 patients (in charge by Psychiatric Centers of Regione Campania - Italy) were assessed using CGI (Clinical Global Impression) and GAF (Global Assessment of Functioning) scales. Moreover economic data were collected with reference to pharmacological and non-pharmacological (hospitalization, medical/nurse visits, etc.) resources consumption. The pharmacoeconomic analysis were conducted choosing the perspective of the local Psychiatric Services for costs attribution. RESULTS: Considering the treatment outcomes, the use of the atypical drugs provided better performances with reference to the patients quality of life. The results in terms of work and social functioning indicated an advantage in the olanzapine group of patients. Overall direct costs of treatment (drugs and healthcare resources) didn’t generate significant differences among the groups of therapy despite the pharmacological cost evidentiated an economic advantage (
Costo-efficacia dell’amfotericina B liposomiale nella terapia dell’aspergillosi invasiva
Get PDFInvasive aspergillosis (IA) is a common and life-threatening infectious complication of immune system depression. Amphotericin B deoxycholate (AMB-d) has been considered standard therapy for IA for over 40 years, despite the fact that success rates rarely exceed 40% and adverse effects are quite common. At present two more recent pharmacological agents are available for the treatment of IA: liposomal amphotericin B (L-AMB) and voriconazole (VOR). In this article, we present a pharmaco-economical study comparing the relative costeffectiveness of 5 alternative strategies in the treatment of invasive aspergillosis, analysed from the point of view of the Italian hospital: administration of L-AMB as first line therapy, followed by no rescue treatment in case of failure (L-AMB I°); administration of L-AMB as first line therapy, followed by VOR in case of failure (LAMB I° + VOR rescue); AMB-d as first line, followed by L-AMB in case of failure (L-AMB rescue); AMB-d as first line, followed by other antifungals as needed (AMB-d I°) and VOR as first line, followed by rescue treatments in case of failure (VOR I°). The cost-effectiveness analysis was conducted using decision tree modelling techniques: efficacy data were obtained from published clinical trials; costs parameters were fitted on the Italian setting. The results indicate that two strategies, L-AMB rescue and VOR I°, are dominated, i.e. induce higher costs and lower success rates than the alternatives. The three remaining strategies are neither dominated nor dominate the others, but are associated with different clinical and economical outcomes: AMB-d I° has the lowest total cost, but also the highest cost-effectiveness ratio and the lowest overall efficacy; L-AMB I° has the best cost-effectiveness, but requires the willingness to pay 2,100 euro for each additional success; L-AMB I° + VOR rescue is the most effective treatment, but this choice is associated with incremental costs of 17,200 euro for each additional success, compared with L-AMB I°. In conclusion, our analysis indicates that for clinical, economical and ethical reasons the best option in the treatment of IA is the administration of L-AMB as first line therapy, thus limiting the use of VOR to the rescue of the patients not cured by this approach
Tramadolo: profilo farmacologico, terapeutico e farmacoeconomico
Get PDFTramadol is an effective central analgesic with a dual mechanism of action: antagonism on mu-opioid receptors and inhibition of serotonin and norepinephrine reuptake. In this paper a pharmacological, clinical and economical profile of its use in pain management is provided. Tramadol has proven effective in the treatment of moderate and severe pain associated with acute and chronic conditions of different ethiology, at oral or parenteral doses of about 50-100 mg every 4-6 hours. The maximal daily dose should not exceed 400 mg, less in case of liver or kidney dysfunction. Tramadol has low potential for physical or psychological dependence; the minimal likelihood of provoking typical opioid adverse events represents an advantage over other morphine-like agents. From a pharmacoeconomical point of view, tramadol prescription appears to be efficient: the comparisons conducted in the management of post-surgical pain have shown tramadol to be more convenient than the studied alternatives. Overall, tramadol appears to be a safe and effective drug for the management of pain and it is one of the most relevant week opioids to be used in the second step of the pain management latter proposed by the WHO. The recent introduction of generic tramadol permits to choose among more products and allows to obtain savings on the cost of managing acute and chronic painful conditions
Farmacoeconomia ed etica: cure sostenibili e rispetto della persona
Get PDFThe scarcity of economic resources today is a fundamental problem in public healthcare. The importance of making well-founded choices for optimal resources allocation concerns also pharmacological treatments and is justified also on ethical grounds, besides the economic, political and/or medical considerations. In fact, a better management, also in economic sense, of the patient and sickness involves the possibility of offering an efficient treatment to all the sick, or at least to as many of them as possible. However, these considerations should always be subordinated to the ethical centrality of the patient, to the protection of his life, his health and his personal dignity, to the extent that life and health are priceless. The goal of ethics in pharmacoeconomics can be summarised in respect for the person, which must remain the end and reference of every therapeutic choice as well as every healthcare policy. The indispensable instruments for the realisation of the above objectives are, amongst others, those already highlighted but which demand further explanation: a) a suitable standard background/training and a multidisciplinary approach for optimising the evaluation procedures and increasing accuracy and verifiableness of the data; b) measures to contrast and disclose the conflict of interest for more transparency and credibility; c) a coherent evaluation of the ethical quality and humanness of the pharmacoeconomic analysis which requires a correct consideration of quality of life and a real respect for persons
Il prezzo dei farmaci orfani in Italia: il caso di Citarabina Depot (DepoCyte®) nella meningite linfomatosa
Get PDFOrphan drugs definition should be related to prevalence criteria. In Europe the prevalence criterion is 5/10.000. These drugs are called “orphans” because the pharmaceutical industry has little interest under normal market conditions in developing and marketing products intended for only a small number of patients. For this reason governments have emphasized the need for economic incentives to encourage drug companies to develop and market orphan drugs. Aim of this study is the analysis of the contributing factors involved in the price definition of orphan drugs in Italy, focusing on the case of DepoCyte®, a new orphan drug recently approved by the European Medicines Agency. DepoCyte® is a slow-release formulation of cytarabine designed for intrathecal administration in the treatment of neoplastic meningitis due to metastatic cancers. It maintains cytotoxic concentrations of free cytarabine in the cerebrospinal fluid for more than 14 days following a single injection. In two randomized clinical trials DepoCyte® was compared to standard formulation of cytarabine, showing a better time to neurologic progression and survival trend in favor of DepoCyte®, associated with an improved mean change about quality of life in Karnofsky performance score. The innovative technology and the efficacy of DepoCyte® allow to frame some interesting pharmacoeconomical consequences: the results of the present work showed that DepoCyte® is more expensive but also more effective than standard formulation, and the new formulation-correlated improvement in the patients’ quality of life seems to justify the difference between the costs of the two alternatives
Levetiracetam: review clinica ed economica di un nuovo antiepilettico
Get PDFUncontrolled epilepsy has a significant negative impact on patient’s quality of life, on his emotional well-being and his social functioning. Seizure places an undue economic burden on the patient and community. The increased costs are direct and indirect (e.g.,inpatient care and loss of earnings associated with time lost from work). Levetiracetam is a new antiepileptic drug used as adjuntive therapy in the treatment of refractory epilepsy. Its nonconventional mechanism of action is not completely understood, but preclinical studies suggest that its antiepileptic action.may depend on a reversible, saturable and stereoselective binding site in CNS membranes. In this paper, we review the main clinical and economic data available in the scientific literature. Levetiracetam has a favourable pharmacokinetic profile characterised by rapid and nearly complete absorption, very low potential for drug interactions and a prolonged pharmacodynamic effect that permits twice-daily dosing. Several placebo-controlled clinical trials have demonstrated that its efficacy has enabled many patients who were refractory to treatment with other antiepileptic drugs to achieve long-term seizure freedom; furthermore in levetiracetam trials the frequency of adverse events is low and withdrawal rates are comparable with those of placebo. A cost/effectiveness analysis compared direct medical costs of levetiracetam add-on therapy with maintenance of standard therapy alone within the UK National Health Service. A 1-year dose escalation decision model was set up in refractory patients who failed to respond to two or more other currently available therapies, with seizure freedom selected as the measure of effectiveness. Available pharmacoeconomic data show that the incremental cost of treating patients with levetiracetam is low when compared with the benefits of seizure freedom, at least in the UK. Furthermore, current studies suggest that this antiepileptic drug has a potential as first-line treatment for many types of epilepsy and in many different patient populations
Implicazioni cliniche ed economiche di tramadolo SR
Get PDFTramadol is one of the preferred weak opioid agonists in the management of chronic pain, due to a good efficacy and safety profile, to a particularly low interference with cardiovascular and respiratory functions and a low dependence and abuse potential. The successful use of tramadol, nevertheless, is often limited by low patient compliance, a consequence of gastrointestinal side effects (mainly nausea and vomiting) and frequent dosing regimens, among other reasons. In this paper, clinical studies conducted on slow-release formulations of tramadol and other strategies for compliance improvement in various pain conditions are reviewed. From the examined literature, it appears that the strategy with the best compliance is the use of slow release (SR) formulations, which simplify dosing regimens and tend to have a somewhat better tolerability, and a slow dose escalation, which improves tolerability. The advantages of SR formulations have to be weighed against the superior acquisition cost and the slower onset of analgesia. A frame for the evaluation of the clinical and economical advantages and disadvantages of SR versus immediate release formulations of tramadol is also proposed
Impiego degli Inibitori della Pompa protonica (IPP) in Piemonte: indagine sulle abitudini prescrittive dei Medici di Medicina Generale
Get PDFProton Pump Inhibitors (PPIs) (Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole and Esomeprazole), one of the most commonly prescribed classes of medications in the primary care setting, are considered a major advance in the treatment of acid-peptic diseases. In Italy PPIs are reimbursed by National Health Service on the basis of CUF (Commissione Unica del Farmaco) 1 and 48 Notes. In 2002 and 2003 a significant increase in PPIs consumption and expenditure have been documented, showing differences between regions. The aim of this study is to investigate and monitor, at regional level, type and entity of PPIs use through a drug utilization study, evaluating prescribing behaviour and compliance of PPIs treatments with CUF Notes indications. The study has been carried out on a sample of 436 General Practitioners belonging to 22 Piemonte’s ASL (Aziende Sanitarie Locali). The data analysis shows that acid-related pathologies are significantly more common in patients with at least 50 years of age and the most frequent condition is represented by gastroesophageal reflux disease. Despite the general conditions of PPIs use by General Practitioners in terms of duration and dosage of therapy result in most cases (from 49% to 80% for duration and from 54% to 97% for dosage) compliant with what proposed by CUF Notes, in some cases the same CUF Notes indications seem to be not observed. Consequently the Piemonte Region has decided to plan a guideline on PPIs rational use. Such guideline, expected to be introduced in the regional area, may also be considered as an instrument able to lead to a more appropriate expenditure for this drug class. Moreover, in order to control PPIs expenditure, pharmacoeconomic methodologies can be applied allowing to identify the most cost - effective active substance and therapeutic scheme, overcoming CUF Notes which consider all PPIs use under the same reimbursement conditions
Analisi di minimizzazione dei costi del trattamento della leucemia cronica con fludarabina fosfato (Fludara®) e.v. e p.o.: metodologia e risultati di un’indagine empirica
Get PDFThe aim of the paper is to compare healthcare-related costs of a 5-day course with fludarabine phosphate i.v. vs a 5-day course with oral fludarabine phosphate in Italian patients with chronic leukemia. A cost-minimization analysis was performed from both Italian National Healthcare Service (INHS) and hospital perspectives. Healthcare-related costs were collected from 2 out of a sample of 28 Ematology wards and included those of drug acquisition, drug preparation, drug administration, reception and discharge of patient before and after drug administration; hospital overheads were calculated as a percentage of the total healthcare-related costs. The reimbursement schemes for acquisition and administration of fludarabine phosphate i.v. were gathered from the whole sample of 28 Ematology wards taken into account. Costs were expressed in euros 2004. When compared to fludarabine phosphate i.v., oral fludarabine phosphate allowed savings ranging from 223,47 euros (hospital perspective) to 477,05 euros (INHS perspective) per patient. As far as hospital perspective was concerned, savings associated with oral fludarabine phosphate were due to hospital overheads (115.1%), drug preparation (19.6%), drug administration (17.3%), reception and discharge of patient before and after drug administration (2.9%), whereas costs for drug acquisition was higher for oral formulation (-54.8%). When INHS perspective was taken into account, 3 out of 28 Ematology wards (11%) were reimbursed on a drug-plus-outpatient-drug-administration-basis, whereas 25 out of 28 Ematology wards (89%) were reimbursed on a day-hospital-stay-basis. Savings associated with oral fludarabine phosphate were due to day-hospital stay (253.4%), outpatient drug administration (1.1%), whereas cost for drug acquisition were higher for oral formulation (-154.5%). Sensitivity analysis confirmed the robustness of basecase results. Savings associated with oral fludarabine phosphate may be of relevant interest for INHS policies aimed at reducing public expenditure for drugs in Italy
Una valutazione economica di citrato di fentanile ad assorbimento orale (Actiq®) per la terapia del dolore in pazienti affetti da cancro
Get PDFBreakthrough cancer pain is a component of chronic cancer pain that is particularly difficult to treat due to its severity and rapid onset. Effective relief of cancer pain is an integral part of comprehensive cancer care. Many cancer patients experience persistent pain that is treated with a fixed scheduled opioid regimen. But these patients can experience acute breakthrough pain, with sudden onset that occurs spontaneously or as a result of activity. To supply this occurrence is indicated an addictional prescription of opioids. The ideal preparation for managing breakthrough pain is one that is able to mirror its characteristics, i.e. rapid in onset and relatively short in duration. Oral transmucosal fentanyl (Actiq®), an innovative form of fentanyl citrate, provides a rapid onset of pain relief and it is more appropriate than morphine for treating episodes of breakthrough pain. Besides the impact on the patients’ quality of life, cancer pain involves remarkable expenditures, as direct and indirect costs, by the National Health Care System and the Society. This study presents the estimation of the costs associated with the use of oral transmucosal fentanyl (Actiq®). Aim of the study is to verify if the use of oral transmucosal fentanyl (Actiq®) can be considered as cost saving or cost effective compared with current therapy