Farmeconomia. Health economics and therapeutic pathways
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Palivizumab nella profilassi del virus respiratorio sinciziale: analisi di impatto sul budget del SSN italiano
Get PDFPalivizumab is a monoclonal antibody to RSV that has been shown to significantly reduce the frequency of hospitalisations for RSV infection, in at-risk populations. However, payers are concerned about the budgetary impact of adopting palivizumab. A budget impact model was developed to estimate the financial impact of palivizumab for the prevention of severe RSV infection in at-risk populations in the Netherlands. These analyses were adapted to Italy, after a brief review of the literature on the health care system and epidemiology of RSV infection in our country. The report below outlines the methodology and analysis of the costs associated with palivizumab prophylaxis of premature infants of 33 to 35 weeks gestational age which are the at-risk subgroup eligible for prophylaxis according to Italian guidelines
Palivizumab e virus respiratorio sinciziale: una panoramica
Get PDFRespiratory Syncytial Virus (RSV) is a very frequent cause of respiratory infections in the first two years of life. Symptoms often are mild to moderate, but in some high-risk categories of infants, particularly prematures and children with bronchopulmonary dysplasia or congenital heart disease, RSV can cause severe lower respiratory tract infections with need of hospitalisation, and, sometimes, even death. No effective treatment is available, and specific vaccines, despite several attempts during the last decades, do not exist. Palivizumab is a humanised monoclonal antibody targeting specific viral mechanisms controlling infection. If administered intramuscularly monthly during the RSV season as prophylaxis to high risk patients < 2 years of age, this antibody effectively reduces hospitalisation rates and severity of RSV infection. Based on the data from the two main phase III trials conducted so far, palivizumab prophylaxis results in 45% to 55% reduction of hospitalisation rate, with a very satisfactory profile of tolerability as most commonly reported adverse events where transient and mild irritability, diarrhoea or fever
Valutazioni economiche di atorvastatina in prevenzione secondaria: un aggiornamento
Get PDFIntroduction: cardiovascular diseases are the most common reason of mortality and morbidity in the world, despite therapeutic interventions have improved patients’ prognosis in the last decades. Aggressive lipid lowering treatment with atorvastatin has demonstrated to be effective in preventing the occurrence of new cardiovascular events requiring hospitalizations, in patients previously affected by coronary syndromes. However, the increasing costs of managing cardiovascular diseases impose a careful analysis of the economic benefits of these therapies. Objective: to assess the economic sustainability of using atorvastatin for the secondary prevention of cardiovascular events. Material and Methods: we derived clinical information from five randomized, multicenter trials (AVERT, IDEAL, MIRACL, PROVE-IT, TNT) evaluating efficacy and tolerability of high dosage treatment with atorvastatin over control groups in different patient populations and for different follow up periods. A costeffectiveness analysis in the perspective of the NHS has been performed, under the hypothesis of the imminent price reduction of atorvastatin, due to the loss of exclusivity. Results: in trials AVERT, MIRACL, PROVE IT, the treatment with atorvastatin has demonstrated to reduce both cardiovascular events and overall healthcare direct costs, compared to the respective control groups. In trials IDEAL and TNT, the therapy with atorvastatin has resulted to be cost effective, with incremental cost-effectiveness ratio respectively of € 6,310 for avoided event (vs simvastatin 10 mg) and € 9,058 for CV disease free patient (vs atorvastatin 10 mg). Discussion: the present study represents an update of previous cost-effectiveness analyses, which have previously evaluated the economic consequences of using atorvastatin for the secondary prevention of cardiovascular events. The present analysis has proved the economic benefits deriving from the usage of atorvastatin, which is a dominant alternative in the AVERT, MIRACL and PROVE-IT clinical settings, and a cost effective
option in the IDEAL and TNT study populations
Valutazione economica dello studio CARDS: un aggiornamento
Get PDFIntroduction: in the last decades, prevalence and incidence of type II diabetes mellitus have been rapidly growing worldwide. Most recent projections estimate that the number of people affected by diabetes is destined to double in 2030, producing a significant increase of the healthcare expenditure for the management of complications. Prevention of cardiovascular events in diabetes population represents a priority for decision makers, who have to evaluate the cost-effectiveness of therapeutic interventions. Objective: to provide an updated cost-effectiveness evaluation of treating type II diabetes patients with atorvastatin versus placebo, in the light of the imminent price reduction of atorvastatin due to loss of exclusivity and of other therapeutic and hospital costs.
Material and Methods: we derived clinical information from the CARDS study, a randomized, multicenter
clinical trial evaluating efficacy of atorvastatin versus placebo in preventing the occurrence of cardiovascular events in a cohort of type II diabetes patients without previous history of coronary events. A cost-effectiveness analysis in the perspective of the National Healthcare System (SSN) has been performed, under the hypothesis of the imminent price reduction of atorvastatin, due to the loss of exclusivity. Results: after a median follow up of 3.9 years, the number of patients with at least a major cardiovascular event requiring hospitalization was lower in the atorvastatin arm (5.8%) compared to the placebo arm (9.0%; p=0.001). Based on a cohort of 1,000 patients, treatment with atorvastatin permitted to gain 29.28 life years. The incremental cost of adding atorvastatin to the standard therapy amounted to €305,682, and was partially balanced by a cost reduction due to fewer hospitalizations, compared to the placebo arm (€ 168,313). Total direct costs were of €602.186 in the atorvastatin group and of € 464,818 in the placebo group, resulting into an incremental cost-effectiveness ratio of € 4,692 for Life Year Gained (LYG). Conclusion: the present study is an update of a previous economic analysis of the CARDS trial. Under the assumed new cost scenario, the cost-effectiveness profile of treating diabetic patients with atorvastatin becomes highly favourable, and leads to a significant reduction of the cost for Life Year Gained compared to the previous findings
Cost of osteoporosis-related fracture in Italy. Results of the BLOCK study
No full textThe objectives of the present study were to calculate the cost of illness of osteoporosis and to assess drug utilization patterns in postmenopausal women after a fracture-related hospitalization. The study subjects were enrolled from a large population-based administrative database. Female patients (age ≥ 65 years) who were hospitalized for a typical osteoporotic fracture between 1/1/2000 and 31/12/2005 were included. Patients were classified as exposed/unexposed to treatment according to the presence/absence of at least one prescription for an osteoporosis-related medication in the 6 months following the discharge date. Treatment adherence was calculated for patients who were exposed to bisphosphonate therapy and was defined as at least 80% of treatment coverage during the follow-up period of 18 months after the discharge date. Hospitalizations, medications, diagnostic tests, laboratory tests and specialist visits during the 18-month follow-up period were collected and classified as osteoporosis-related or non-related to osteoporosis. A total of 12,376 patients were included in the study (mean age ± SD, 79.1 ± 7.5 years), out of which 97.9% (n = 12,110) were hospitalized due to an osteoporosis-related fracture and only 2.1% (n = 266) had general osteoporosis diagnosis. Among the 12,110 women with a fracture, 15.2% (n = 1,845) had a subsequent fracture-related hospitalization (63.8% of the patients had hip fracture). Only 32.3% (n = 4,001) of all included patients was exposed to osteoporosis-related medications and out of those patients exposed to bisphosphonates (n = 860) only 34.2% (n = 294) was adherent to therapy. The average cost per patient was € 4,481, of which € 1,089 was for osteoporosis-related and € 3,392 for non-osteoporosis-related items. The average cost of a matching cohort of patients without hospitalizations for fracture was € 2,339. Among osteoporosis-related costs, 87.0% was due to hospitalizations for subsequent fractures, 1.5% was due to subsquent hospitalizations for osteoporosis, 9.0% was due to medications, 2.5% was due to laboratory or diagnostic/ instrumental tests. Osteoporosis costs after a first hospitalization for fracture were relevant (twice the costs for patients without hospitalizations for fracture), evident in the short run (within the first 24 months following the index fracture) and mostly due to re-hospitalizations for a new typical osteoporotic fracture. This is in mainly relatedto a low exposure to pharmacological therapy and to insufficient treatment adherence. This study and publication were supported by Amgen Dompe and GlaxoSmithKline.
Cost-effectiveness evaluations of spinal neuromodulation with ziconotide continuous infusion in cancer pain in a real clinical practice
No full textIntroduction and objective: ziconotide is the first-in-class drug of selective N-type voltage-sensitive calcium-channel blockers used to control severe chronic pain. The present study is developed in order to analyze clinical and economical outcomes of spinal neuromodulation with ziconotide continuous infusion in cancer pain in a real clinical practice.Methods: costs and effects of ziconotide are compared with those of traditional neuromodulation with morphine and adjuvant drugs, administered by intrathecal infusion.Effectiveness and resources consumption data were retrospectively collected in 22 patients with severe complex cancer pain followed by one Italian centre from the day of port implantation to drop-out , due to death or consent withdrawal. 11 patients received morphine regimens and the other 11 were treated with ziconotide. The evaluation of the number of days with controlled pain (i.e., with an at least 30% reduction on the Numeric Rating Scale-Pain Intensity, NRSPI) is the primary outcome of the analysis. The evaluated consumed health resources include drugs, visits, port maintenance, and pump recharge and amortization. Current Italian prices, real practice acquisition and remuneration costs borne by the third payer are applied.Results: patients receiving ziconotide lived significantly more days with controlled pain (78% vs 40%; p < 0.05). Average weekly cost is about 232 € for ziconotide and 120 € for morphine; the main driver being the pharmaceutical cost (respectively 81% and 65% of the total). Higher ziconotide acquisition costs are partially offset by minor expenses for adjuvant therapies, as ziconotide-treated patients on average receive a lower number of drugs than those receiving a traditional regimen. The incremental cost for one further day with controlled pain resulted of 42,30 €.Conclusions: ziconotide permits effective treatment of extremely difficult-to-manage pain, with a mild increment of cost, as compared to intrathecal morphine-based therapy
