Italian National Health Service Perspective Research Articles

An economic evaluation of an abdominal aortic aneurysm screening program in Italy

Abdominal aortic aneurysm (AAA) is defined as a localized dilatation of an aortic vessel. Though predominantly asymptomatic, it is a chronic degenerative condition associated with life-threatening risk of rupture. The early diagnosis of AAA, ie, before it ruptures, is therefore important; a simple, effective diagnostic method is ultrasound examination. To assess the benefit of screening in Italy, we developed a cost-effective Markov model comparing screening vs nonscreening scenarios. A 13-health-states Markov model was developed to compare two cohorts of 65- to 75-year-old men: the first group undergoing screening for AAA by means of ultrasound (US), the second following the current practice of incidental detection. The following health states were distinguished: no AAA, unknown small AAA (3-3.9 cm), followed-up small AAA (1 year), unknown medium-sized AAA (4-4.9 cm), followed-up medium-sized AAA (6 months), unknown large AAA (>5 cm), elective repair, emergency repair, postelective-repair AAA, postemergency-repair AAA, rejected large AAA, and death. Transitions between health states were simulated by using 6-month cycles. Transition probabilities were derived from a literature review of relevant randomized controlled trial and from a screening program that is currently ongoing at San Martino Hospital in Genoa, Italy. The Italian National Health Service (NHS) perspective was adopted and incremental cost per life-year saved was calculated with a lifetime horizon; costs and health benefits were discounted at an annual rate of 3% from year 2 onward. Uncertainty surrounding the model inputs was tested by means of univariate, multivariate, and probabilistic sensitivity analyses. Considering an attendance rate of 62%, the individual cost per invited subject was €60 (US $83.2); 0.011 additional quality adjusted life years (QALY) were gained per patient in the screened cohort, corresponding to an incremental cost-effectiveness ratio (ICER) of €5673/QALY (US $7870/QALY). The results were sensitive to some parameter variations but consistent with the base case scenario. They suggest that on the basis of a willingness-to-pay threshold of €50,000/QALY, screening for AAA is cost-effective, with a probability approaching 100%. As in economic evaluations developed in other countries, such as the UK, Canada, and The Netherlands, setting up a screening program for AAA can be considered cost-effective from the Italian NHS perspective.

An economic analysis of rotavirus vaccination in Italy

We have evaluated health and economic benefits of a universal infant vaccination with two rotavirus vaccines registered in Italy, on the bases of the burden of rotavirus gastroenteritis (RVGE) in a birth cohort of 520,000 Italian infants followed until 5 years of age. Estimates from published and unpublished sources of disease burden, costs, vaccine coverage, efficacy trials of both vaccines, and price were used to estimate cost-effectiveness from the perspectives of the Italian National Health Service (NHS) and society. According to our estimates, a universal rotavirus vaccination program would avoid 10,679 hospitalizations, 39,202 emergency visits, and 44,223 at home visits. At €65.6 per vaccination courses, the program would cost €30,700,800 and realize a net loss of €9,057,928 from the Italian NHS perspective. On the contrary, the program would provide a net savings of €24,324,198 from the societal perspective. From the Italian NHS perspective, the break-even price per vaccination course should be reduced at least to €46.25 to achieve a zero cost-effectiveness ratio.

Cost minimisation analysis of 12 or 24 weeks of peginterferon alfa-2b + ribavirin for hepatitis C virus

Background: Pegylated interferon and ribavirin are at present the standard treatment for chronic hepatitis C virus (HCV) patients.Objective: The present economic evaluation compared 12 vs. 24 weeks of peginterferon alfa-2b + ribavirin treatments for HCV genotypes 2 or 3. Shortening the period of antiviral therapy is important in terms of adverse events and costs.Methods: Clinical evidence was based on the results of a multicentre, randomised controlled clinical trial (RCCT) conducted in Italy, which found that the shorter course of therapy was as effective as the 24-week course for patients with HCV genotypes 2 or 3 responding to treatment at 4 weeks. A cost minimisation analysis was performed. The analysis took the Italian National Health Service (INHS) point of view, thus only healthcare costs (drugs, medical consultations, diagnostic tests, hospital admissions) were considered. Healthcare activities were estimated by the RCCT principal investigators and were priced by applying the INHS tariffs and prices.Results: The total mean cost per patient was estimated at €9,785 for the standard group and €7,508 for the variable-duration group. Sensitivity analysis confirmed the robustness of the baseline results.Conclusions: This study showed that the variable-duration regimen can be recommended as an efficient use of resources for patients from the INHS perspective.

Resource consumption and costs of treating pain in patients affected by cancer in a district of northeast Italy

WHO declared that pain is a relevant problem in public health and that opioids are the gold standard therapy for the treatment of moderate to severe pain. The present retrospective, epidemiological, observational study is aimed to evaluate resource consumption therapy in patients treated with opioids and died with a diagnosis of cancer in Treviso, a district in northeast Italy. For the monetisation of resource consumed, the Italian National Health Service perspective was adopted. For each patient, resource monetized were drugs (opioids, NSAIDs and adjuvants), hospitalizations with cancer diagnosis, diagnostic examinations and laboratory tests. All databases were linked in order to obtain patient profile of resource consumption. A total of 935 patients were included in the study. The incident opioid prescribed were for 60% morphine, 37% fentanyl, and 2.5% buprenorphine. The average length of treatment with opioids was 105 ± 73 days. Of the patients included in the study, 79% received an anti-inflammatory drug (traditional NSAIDs and/or COX2 inhibitors), while 21% of patients treated with opioids never had an anti-inflammatory reimbursed prescription during the observation period. The average length of anti-inflammatory treatment was 133 ± 83 days. For the vast majority of prescribed anti-inflammatory drugs, the received daily dose (RDD) was widely greater then the defined daily dose (DDD) before and during treatment with opioids, while for opioids the RDD was in line with the revised DDD for fentanyl, and less than the DDD for morphine and buprenorphine. The total daily cost per patient before the first prescription of opioids was €11.36 while after the first prescription of opioids, it increased to €21.12. This study confirms the under utilization of opioids in Italy both in terms of dosages and length of therapy.

Direct medical costs of monitoring and treating patients with Takayasu arteritis in Italy.

The study provides the first overall estimate of the costs of Takayasu arteritis (TA) monitoring and treatment in Italy and highlights the differences in cost components across defined subgroups of patients. We estimated resource consumption and direct costs from the Italian National Health Service perspective. We conducted a multicenter, prospective study in 12 medical departments. All the 67 patients recruited met the American College of Rheumatology 1990 criteria for the classification of TA and were followed up for 1 year. For the purpose of analysis they were divided into two groups: "active TA" (patients who had taken at least one drug specific for TA treatment, i.e., corticosteroids and/or cytotoxics), and "inactive TA" (all the remaining patients). The average cost per year was Euro 4,079. Patients with active TA (Euro 5,055) had a significantly higher mean cost per year than those with inactive TA (Euro 1,328). In particular, significant differences were found for costs in general practitioner consultations, laboratory tests, and hospital admissions. These findings suggest that patients not only experience more complications requiring hospital admissions but also see general practitioners more often during the active stage of the disease, presumably in order to obtain a prescription for laboratory tests.

Direct cost of medical management of epilepsy among adults in Italy: a prospective cost-of-illness study (EPICOS).

To investigate the costs of epilepsy from a nationwide survey comparing adult patients included in different prognostic categories. A 12-month prospective observational study was conducted in 15 epilepsy centers from Northern, Central, and Southern Italy. The study population included a random sample of individuals aged 18 years and older with newly diagnosed (ND) epilepsy, seizure remission (R), occasional seizures (OS), active non-drug-resistant (NDR) seizures, drug-resistant (DR) seizures, or surgical candidates (SC). Estimates of the direct costs of care of epilepsy were based on the use of diagnostic examinations, laboratory tests, specialist consultations, hospital admissions, day-hospital days, and drugs, taking the Italian National Health Service perspective. The sample included 631 patients (ND 62, R 158, OS 155, NDR 114, DR 128, and SC 14). The SC group had the highest total cost per patient (3,619 euros) followed by DR (2,190 euros), ND (976 euros), NDR (894 euros), OS (830 euros), and R (561 euros). For each epilepsy group, the main components of the total cost were drugs and hospital admissions. Drug costs increased from the R group to the DR group. The new antiepileptic drugs (AEDs) were the largest part of the cost of treatment. The costs of epilepsy in referral patients vary significantly according to the time course of the disease and the response to treatment. Hospital admissions and drugs are the major sources of expenditure.

Direct costs of schizophrenia and related disorders in Italian community mental health services: a multicenter, prospective 1-year followup study.

The behavior that accompanies schizophrenia and related disorders interferes with professional and social activities. As a result, schizophrenia is one of the most costly psychiatric illnesses. Direct medical costs associated with schizophrenia were estimated from the Italian National Health Service perspective. This was a multicenter observational 1-year study conducted in 14 Italian community mental health centers (CMHCs). Eligible patients were those with a diagnosis of schizophrenia or schizoaffective or schizophreniform disorder who had been followed by the CMHCs for at least 2 years at study entry. Exactly 643 patients were enrolled in the study. The mean direct cost per year was 6,964 (27,025 for schizophrenia and 6,587 for patients with related psychotic disorders) (1998 exchange rate U.S.$1 = 1.121). The present study provides further estimates of the cost of schizophrenia treatment in Italian mental health services and highlights the variability in the single cost components across clinically defined subgroups of patients.

Cost-analysis of a 6-week cycle of therapy with celecoxib vs conventional NSAIDs in ostheoarthritis in Italy

Objectives To estimate the cost in the Italian National Health Service (INHS) perspective of a 6-week treatment course with celecoxib vs NSAIDs in ostheoarthritis patients.

Efficacy and Safety of Short Course (5-day) Moxifloxacin vs 7-day Ceftriaxone in the Treatment of Acute Exacerbations of Chronic Bronchitis (AECB)

The aim of this multicenter, open, randomized study was to compare the efficacy and tolerability of a 5-day treatment course with oral moxifloxacin (MXF) vs a 7-day course with i.m. ceftriaxone (CRO) in 476 patients with acute exacerbations of chronic bronchitis (AECB), and to conduct a cost minimization analysis of the two treatments from the perspectives of both the Italian National Health Service (INHS) and society. The study was conducted in Italy. Clinical success rates at test-of-cure in the 423 patients of the PP (Per Protocol) population (primary efficacy parameter) were 90.6% and 89.0% for MXF and CRO, respectively. Statistical non-inferiority of MXF vs CRO was confirmed. Similar results were found between study drugs on the secondary efficacy parameters, including success at end-of-treatment (95.3% for MXF vs 92.9% for CRO), success at test-of-cure in bacteriologically-positive patients (94.1% vs 90.7%) and eradication/presumed eradication rates (91.7% vs 93.3%). ITT (Intention-to-Treat) analysis confirmed these data. There was a low incidence of adverse events (10.8% vs 9.1%). During a 6-month follow-up period, relapse rates were lower for MXF vs CRO (23.3% vs 28.3%; p>.05). Compared with CRO, MXF was associated with cost savings per patient ranging from €226.57 (INHS perspective) to €448.23 (societal perspective), with lower hospitalization rate the major variable contributing to reduced costs. MXF appears to be an ideal candidate for AECB treatment.

Cost-Effectiveness Study of Imipenem/Cilastatin versus Meropenem in Intra-Abdominal Infections

Background: The efficacy of two carbapenems, imipenem/cilastatin (I/C, 1.5 g daily) versus meropenem (3 g daily) in intra-abdominal infections was assessed in a recent multicenter randomized clinical trial. The aim of this article is to perform a cost-effectiveness analysis as in real-world practice according to the findings of this clinical trial. Methods: A decision tree was used to estimate the clinical outcomes and direct costs of treating intra-abdominal infections using the two carbapenems from the perspective of the Italian National Health Service (INHS) or a private insurance company (PIC). Results: In a population of 30,000 patients with intra-abdominal infections in Italy, it was estimated that 97 potential deaths/year could be avoided if these patients were treated with I/C versus meropenem. In addition, from the perspective of INHS, the total costs of treatment were estimated as ITL 106,874 million and 134,042 million for I/C and meropenem, respectively. In favor of the PIC point of view, the total costs were estimated as ITL 110,500 million and 135,899 million for I/C and meropenem, respectively. Conclusion: The treatment of intra-abdominal infections with I/C is shown to be more effective (97 deaths avoided/year) and less costly than with meropenem (with a saving of ITL 27,168 and 25,399 million/year for INHS and PIC, respectively).