Farmeconomia. Health economics and therapeutic pathways
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Clinical and pharmacoeconomic profile of lanthanum carbonate treatment of hyperphosphataemia in chronic renal dialysis patients
No full textHyperphosphatemia is recognized as a principal mineral disorder in chronic kidney disease (CKD) that leads to the development of secondary hyperparathyroidism. Approximately 70% of patients with end-stage renal disease (ESRD) and dialysis have hyperphosphataemia, which is associated with renal osteodystrophy, metastatic calcification and increased mortality and morbidity. Despite dietary restriction and dialysis, most patients will require a phosphate-binding agent to treat this condition.Lanthanum carbonate is an new, potent, selective, no-resin, non-calcium phosphate binder that retains high affinity for phosphate over a wide pH range, does not bind bile acids or contribute to metabolic acidosis. Taken with food, it is well tolerated. It is poorly absorbed and does not require functioning kidneys to be removed from the body. There is no evidence from current studies that it accumulates to biologically significant levels in tissues. Lanthanum carbonate has been shown in clinical studies of up to 6 years to be an effective, well-tolerated phosphate binder. Lanthanum carbonate controls hyperphosphataemia without increasing calcium intake above guideline targets and has the potential to reduce pill burden and increase patient compliance compared with other phosphate binders. Reported adverse effects are mainly gastrointestinal, and do not differ from those of calcium carbonate. The new phosphate binders, lanthanum carbonate and sevelamer, have increased the possibilities for serum phosphate control, at the expenses of significant increases in costs. The cost-effectiveness of lanthanum carbonate has been assessed by three different studies. A recent analysis, conducted on the perspective of the UK NHS, shows it is cost-effective to follow current treatment guidelines and treat all patients who are not adequately maintained on calcium carbonate (serum phosphorus above 5.6 mg/dl) with second-line lanthanum carbonate. This is particularly the case for patients with serum phosphorus above 6.6 mg/dl. A retrospective analysis, performed on IHCSI data base (USA), and a prospective study conducted in Spain show that lanthanum carbonate is cost-effective as compared with sevelamer, requiring less number of tablets, a fact that might improve adherence, and that probably explains better results with lower costs
Fungal infections today: size of the problem and focus on the initial cost of therapy with echinocandin
No full textThree candins had been approved for the treatment of invasive candidiasis (IC): caspofungin, micafungin, and anidulafungin. Different drugs are associated with different needs for dose adjustment which might affect the total cost. A Spanish economic analysis estimated the budget impact of caspofungin, micafungin and anidulafungin in the treatment of 100 patients with invasive candidiasis from the perspective of the Spanish hospital pharmacy setting. It has demonstrated that patients treated with anidulafungin did not required dose adjustment unlike caspofungin and micafungin, and the use of anidulafungin in the treatment of adult non-neutropenic patients with invasive candidiasis is a cost saving treatment option, from the pharmacy department perspective in Spain. The aim of this study was to estimate the initial costs of therapy with caspofungin, micafungin, and anidulafungin in the perspective of the Italian hospital setting
Ipertensione arteriosa polmonare: stima della casistica italiana e considerazioni sull’impatto sul budget dell’introduzione di tadalafil
Get PDFThis contribution is an attempt to estimate a range of Pulmonary Arterial Hypertension (PAH) prevalence in Italy using international literature and Italian drug market sales data and to evaluate the budget impact of the introduction of tadalafil among the actual drugs with specific indication for this pathology. The final epidemiological figure obtained shows a wide range of prevalence of PAH in Italy (900-3,000 cases). The introduction of tadalafil as PAH treatment should not cause a cost increase for the pharmaceutical budget considering that this new therapy will occupy essentially the patient segment actually treated with sildenafil and that it reduces, in a significant number of patients, the daily cost of PAH therapy through a stable, fixed dose, administration
Economic evaluation of the use of saxagliptin in the treatment of type 2 diabetes in Italy
No full textIn this study we compare the cost-effectiveness of saxagliptin (Onglyza®) in combination with metformin to that of either sulphonylurea (SU) plus metformin or a thiazolidinedione (TZD) plus metformin, in type 2 diabetes mellitus patients who are not well-controlled on metformin alone. By using decision-analytic modeling, long-term costs and health outcomes associated with the investigated treatment strategies are estimated. This is achieved by modeling the risk of experiencing diabetes-related events (e.g. myocardial infarction) or side-effects such as hypoglycemia and weight gain. The risk of these events depends on baseline characteristics as well as risk factors (which can be altered by the treatment strategies). Ultimately, costs (NHS perspective) and quality-adjusted life years (QALYs) for each treatment strategy are based on the occurrence of these events. Based on these estimates incremental cost-effectiveness ratios (cost per QALYs) are calculated. In the analysis comparing saxagliptin + metformin with SU + metformin in 1,000 patients in a 40 years time horizon, the total QALY gain with saxagliptin + metformin is 111. The incremental cost with saxagliptin + metformin is € 1,300,000, resulting in a total cost per QALY gained with saxagliptin + metformin of € 11,800 in the base case scenario. Similarly, the comparison with TZD + metformin resulted in a total QALY gain with saxagliptin + metformin of 127, with an incremental cost of € 144,000, resulting in a total cost per QALY gained with saxagliptin + metformin of € 1,100 in the base case scenario. The results are mainly driven by differences in hypoglycemias (associated with a utility decrement and a monetary cost) and weight gain (which is associated with a utility decrement and also increases the risk for diabetes-related events). Saxagliptin + metformin is associated with small difference in macrovascular events such as myocardial infarction, congestive heart failure compared to SU or TZD plus metformin strategies, probably due to the difference of action on net weight. Since the treatment cost is higher with saxagliptin + metformin, total costs are also higher for the Onglyza®-based strategy although the higher drug cost is partially offset by the lower rate of macrovascular costs and reduced cost of severe hypoglycemias. The present analysis suggests that saxagliptin, when added to metformin, is a cost-effective treatment alternative for type 2 diabetes mellitus patients in Italy who are not well-controlled on metformin alone. Both compared to SU + metformin and TZD + metformin, the cost-effectiveness results of saxagliptin + metformin are robust to various assumptions concerning input variables. Hence, the favorable safety profile for saxagliptin, with a risk of hypoglycemia and impact on weight similar to placebo, makes it possible to increase the utility for patients since it is not reducing risk of diabetes-related events per se
Cost/effectiveness model of dabigatran in the prevention of venous thromboembolism in major orthopedic surgery: Adaptation for Italy
No full textVenous thromboembolic events (VTE) represent a dangerous complication of major orthopedic surgery, especially in total hip replacement (THR) and total knee replacement (TKR) procedures. Dabigatran etexilate (DBG), a direct and reversible thrombin inhibitor, has proven its non-inferiority with respect to enoxaparin 40mg once-daily, a low molecular weight heparin (LMWH), in the prevention of VTE in patients undergoing THR and TKR, in the RE-NOVATE and RE-MODEL trials, respectively. The objective of this analysis was to estimate cost/effectiveness and cost/utility of DBG compared to standard care for the prevention of VTE in Italy. A decision analytic, Markov-chain based model, originally developed for the UK, was adapted to the Italian context. The adaptation involved cost and demographic characteristics, clinical and utility data were not altered. Costs were taken from national observational studies, where available. Otherwise, current prices and tariffs were applied. Resource consumption was derived from practice guidelines or taken from the UK model. According to the prevalent national practice, extended prophylaxis is considered for both surgical procedures. The time horizon of the analysis was patients’ lifetimes. In order to consider different alternatives for drug dispensation and, consequently, National Health Service acquisition costs, alternative scenarios were developed. A further scenario, excluding LMWHs administration costs (“worst-case” scenario), was considered. Compared to LMWHs, DBG was associated with an expected increase of 0.019 life-years (LYs) and 0.014 quality-adjusted life-years (QALYs) per THR patient and of 0.024 LYs and 0.019 QALYs per TKR patient. DBG-related costs were lower than LMWH in both procedures, with a mean difference ranging from 89 to 116 € for THR, and 107 to 142 for TKR, depending on the LMWH product. Higher acquisition costs for DBG were completely offset and inverted by avoided administration expenses and, to a lesser extent, by savings in VTE management. The results of alternative scenarios confirm the dominance of DBG, with a net saving ranging between 119 €, when both drugs were obtained by auction, and 32 €, when the auction price was applied but DBG was dispensed through territorial pharmacies. The corresponding estimates for TKR were 148 and 54 €. In the “worst-case” scenario, DBG was no longer dominant, with a cost per LYs of 2,788 and 4,514 € and a cost per QALY gained of 3,619 and 5,926 €, for TKR and THR respectively. In conclusion, DBG dominated LMWHs, and was cost-saving and non-inferior in terms of efficacy and safety, except for in the “worst-case” scenario, in which the incremental cost/effectiveness ratio estimate was lower than commonly accepted thresholds in health economics
Pharmacoeconomic evaluation of the costs incurred by the ASP Messina for home therapy with liquid oxygen
No full textChronic obstructive pulmonary disease (COPD) is a very frequent disease in all industrialized countries. The cost for the community includes cost for hospitalisations, doctor visits, home care, rehabilitation, loss of working days, etc. From a therapeutical point of view, an effective progression of therapy and patients survival can be obtained only by stopping smoking and by following a long term oxygen therapy. The aim of this retrospective study is to evaluate costs of liquid oxygen therapy performed at home. Obtained results are very encouraging because a part from being cheap they also provide a better evaluation of the prescribed therapy which can also be extended to gaseous oxygen
Tiotropium in COPD: clinical outcomes and economic evidence
No full textTiotropium bromide is a once-daily anticholinergic bronchodilator with duration of action of at least 24 hours. In clinical trials, tiotropium has been compared with placebo, ipratropium or salmeterol, the most frequently used long-acting β2 agonist. When compared with ipratropium or placebo in COPD management, tiotropium resulted associated with FEV1, dyspnoea and health-related quality of life (QoL) improvement, along with reduced exacerbation and hospitalisation rates. In comparison to salmeterol, it proved to be superior in terms of lung function improvement and exacerbation risk reduction. Recently, the randomised, double-blind trial UPLIFT showed that 4 years of therapy with tiotropium were associated with improvements in lung function, QoL, and exacerbations, and with an effective reduction of mortality compared with control group in 5,993 patients with moderate to very-severe COPD. These encouraging clinical effects are to be traded against the pharmaceutical cost increase induced by the inclusion of tiotropium in routine care. However, published work indicates that this pharmaceutical cost increase may be totally or partially offset by the reduction in costs needed for exacerbations management and hospitalisations. Depending on the setting analysed, tiotropium is estimated to dominate ipratropium and salmeterol or to be associated with an incremental cost of less than € 2,500 per exacerbation avoided. An Italian model based on UPLIFT data shows that therapy including tiotropium induces an incremental cost of € 6,700 for year of life and of € 7,916 for Quality-adjusted Life Year gained, with respect to routine care alone. These values are much lower than commonly accepted thresholds and than cost/effectiveness results estimated for other long-acting bronchodilators. In conclusion, available evidence suggests that tiotropium may prove an appropriate therapeutic option with a largely affordable cost
Prevalence in the Italian regions of pain in patients with diabetic peripheral neuropathy (NDP) and the current costs of drug treatment for principals with specific indication
No full textThe present analysis estimates the prevalence of pain in patients affected by peripheral diabetic neuropathy referring to Italian and English data published recently and the cost of pharmacological treatments related to specifically indicated drugs. 16% of diabetic patients in Italy is affected by pain symptoms during PDN (peripheral diabetic neuropathy). The corresponding prevalence is 425,168 cases annually. A little number of these patients is actually treated with specifically indicated drugs (duloxetine, pregabalin and gabapentin), anyway the increase of share of duloxetine treatments would take to significant savings due to its lower costs among the specifically indicated pharmacological options