Farmeconomia. Health economics and therapeutic pathways
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Rational and irrational factors in the dynamics of pharmaceutical expenditure and in the drug price negotiation
Cost-effectiveness analysis of paclitaxel + carboplatin vs. alternative combinations in the treatment of non-small cell lung cancer
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and its medical and economical burden represents a serious matter in Europe and Usa, due to its high mortality rates and drug costs. Lung cancer is responsible for about 30% of cancer death in men and women; in Europe only about 8 per cent of people with lung cancer survive for 5 years. At present combination chemotherapy based on cisplatin or carboplatin associated with paclitaxel, vinorelbine or gemcitabine is the state of the art for the treatment in patients with stage IIIb or IV NSCLC. Aim of this study was to compare the cost-effectiveness of paclitaxel/carboplatin (PCb), gemcitabine/cisplatin (GC) and vinorelbine/cisplatin (VC) in the perspective of the Italian National Health Service. Therefore we perfomed a semi-Markov decision model mainly based on clinical results from the Italian Lung Cancer Project. The model included differential direct medical costs registered for two years from starting chemotherapy, using tariffs valid for 2005. Benefits was measured by years of life saved (YOLs). The model also allowed to estimate only costs accrued over the period of time, performing a cost-minimisation analysis. According to cost-effectiveness analysis, VC is dominated because it’s more costly and less effective than GC. On the contrary, combination chemotherapy with GC is more inexpensive but less effective than paclitaxel/carboplatin (PCb): in this case we compared the incremental cost-effectiveness ratio (ICER) with a maximum acceptable willingness-to-pay (WTP) value. In the base scenario the ICER of PCb over GC treatment is 52,326 euro/ YOLs, which is definitely lower than the maximum acceptable WTP value. Sensitivity analyses confirmed the robustness of the results from cost-effectiveness analysis in the base scenario
Clinical and pharmacoeconomic profile of esomeprazole in acid-related diseases
Protonic pump inhibitors (PPIs) are the most prescribed drugs for acute and maintenance therapy of gastroesophageal reflux disease, H. pylori-eradication (in association with antibacterial therapy), for ulcers prevention and cure and, recently, for prevention of NSAIDs-induced gastropathy. The high prevalence of these acid-related disorders induces a large consumption of PPIs; actually, they are the first drug class in terms of National Health Service pharmaceutical expenditure. This widespread and gradually increasing use enforces the need of a rational assessment of their impact on health care resources. This paper provides an updated profile of esomeprazole, the first PPI developed as a pure isomer, which property involves an advantageous metabolism, resulting in enhanced delivery to the proton pump compared with racemic omeprazole. Several studies showed that the success rate for healing reflux esophagitis is greater for esomeprazole than for omeprazole and some other PPIs. According to an Italian pharmacoeconomic model, esomeprazole therapy for erosive esophagitis is associated with higher benefits and lower costs as compared to omeprazole and pantoprazole. For long-term management of non-erosive gastroesophageal reflux disease, on-demand approach with esomeprazole shows clinical outcomes similar to daily treatment regimens, with substantial cost-saving. Furthermore, esomeprazole is the only PPI approved for 1-week triple therapy for both the eradication and the healing of H. pylori-associated duodenal ulcer, while the other PPIs registered the indication for H. pylori-eradication and, separately, a dosing scheme for ulcer healing (independently from etiology)
Resistenza all’uso degli ipoglicemizzanti orali nel trattamento del diabete tipo 2: uno studio multicentrico
Type 2 diabetes is an important social and health care system variable due to its large diffusion, frequency of clinical complications and its health care costs. The studied population is relative to 4 italian centers distributed all over the country (Brescia, Roma, Rossano Calabro and Avola). This work has the aim to describe the Italian type 2 population according to treatment choice ruled by diabetes stage, glycemia control and HbA1c concentration. The analysis present a description of the therapeutic changes during the year of observation too, giving a complete picture of patients distribution and their treatment path through diabetes evolution in Italy
Errata corrige: “Valutazione clinica e metabolica dell’impiego dell’insulina Lispro in pazienti con diabete mellito scompensato”
Pharmacoeconomic analysis of biological treatments for psoriatic arthritis
Psoriatic arthritis is an inflammatory and possibly destructive form of arthritis; left untreated, psoriatic arthritis can be a progressively disabling disease. The arthritic manifestations often include debilitating disease of the hands and feet, as well as painful inflammation of the tendon insertions and arthritis of the spine. The most common treatments prescribed for the psoriatic arthritis are nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, corticosteroids and disease-modifying antirheumatic drugs (DMARDs). Due to a recently suggested role of the tumour necrosis factor (TNFα) in the pathogenesis of psoriatic arthritis, new therapies specifically blocking TNFα have been investigated. Aim of the present study is to compare cost/effectiveness (CEA) and cost/utility (CUA) ratios of anti-TNF medications currently available on the Italian market: etanercept, infliximab and adalimumab. The evaluation was conducted through the development of a single Markov model. Clinical data were obtained from three Phase III trials attesting the clinical efficacy of the biological therapies. Both cost/effectiveness and cost/utility analysis were implemented through the deterministic evaluation and the probabilistic evaluation, in order to assess the convenience for the Italian National Healthcare Service. Adalimumab appears to be cost effective for the treatment of psoriatic arthritis, especially considering the incremental cost/effectiveness ratio (ICER) and the incremental cost/utility ratio (ICUR); the results suggest that ICER and ICUR values of adalimumab over etanercept is definitely lower than the maximum acceptable willingness-to-pay value. Moreover, compared with infliximab, adalimumab is less costly and more effective
First drug utilization data related to an anticholinergic agent recently marketed in Italy
A retrospective drug utilisation study was conducted, concerning a new bronchodilator (tiotropium, ATC code: R03BB04) in the first six months after its launch in Italy. The source of data was the administrative database run by a Local Health Unit located in Northern Italy. All patients (920) were selected with at least one prescription for tiotropium between September and December 2004, and data about their use of health resources (hospitalisations, class ATC R03 drugs, lab tests – only drugs and test prescribed in outpatient setting) was collected. Starting from such initial sample, further sub-samples were created (in particular to focus on patients affected by COPD – Chronic Obstructive Pulmonary Disease, for which tiotropium has got the therapeutic indication by the Italian Health Service), for the purpose of different levels of analysis. Results reported in this abstract are referred to the first level (702 patients, aged 40 years or more, still living at the end of the observation period, already with COPD in the previous year); they are expressed as average data per patient on a six-month period. Prescriptions of R03 drugs were 7.8, including 2.4 specifically for tiotropium. To such prescriptions, 348 and 103 DDDs (Defined Daily Doses) respectively corresponded; and, analogously, a cost of 487 and 205 euros. The cost for hospitalisations was 525 euros and the cost for lab tests was 28.5 euros. The other analysis levels (sub-samples with fewer patients) produced not very different outcomes. Evidence given here should prove the potential interest of such kind of studies
The health-economic models: practical aspects and management of uncertainty
Analytic models are a powerful instrument to develop pharmacoeconomic analyses and their importance is growing as they are being increasingly used to make predictions of the consequences of a particular intervention. It is possible to group the most commonly used techniques in three families: decision trees, Markov chains and probabilistic simulation models. Only the last ones take into account a wide range of uncertainties and have the capability to make probabilistic predictions. Discrete-state, discrete-time Markov models are the most used technique, but have some limits due to their structural rigidity that can make appropriate representation of clinical reality difficult. First-order simulation of Markov models produces deterministic results and can be conveniently implemented in a matrix algebra formal framework. In order to take decision based on models prediction deterministic results are not sufficient and it is widely recognized the need to handle uncertainty in its various forms. The task could be accomplished with traditional (deterministic) and/or probabilistic sensitivity analysis. Both analyses provide complementary information on how the parameters and assumptions uncertainty spreads trough the model and are recommended by ISPOR (International Society for Pharmacoeconomics and Outcomes Research) modelling guidelines