Pharmacological control of secondary hyperparathyroidism in hemodialysis subjects: a cost consequences analysis of data from the FARO study.

BACKGROUND AND OBJECTIVES: Secondary hyperparathyroidism (SHPT) is a frequent complication of CKD with incidence, prevalence, and costs increasing worldwide. The objective of this analysis was to estimate therapy cost of SHPT in a sub-population of the FARO study. MATERIALS AND METHODS: In the FARO study, an observational survey aimed to evaluate patterns of treatment in patients with SHPT who had undergone hemodialysis, pharmacological treatments and biochemical parameters evolution data were collected in four surveys. Patients maintaining the same treatment in all sessions were grouped by type of treatment and evaluated for costs from the Italian National Health Service perspective. RESULTS: Four cohorts were identified: patients treated with oral (PO) calcitriol (n=182), intravenous (IV) calcitriol (n=34), IV paricalcitol (n=62), and IV paricalcitol+cinacalcet therapy (n=20); the cinacalcet monotherapy group was not analysed due to low number of patients (n=9). Parathyroid hormone (PTH) level at baseline and effectiveness of treatments in suppressing PTH level were assessed to test comparability among cohorts: calcitriol PO patients were significantly less severe than others (PTH level at baseline lower than 300 pg/ml; p<0.0001); calcitriol IV patients did not reach significant reduction in PTH level. Paricalcitol and paricalcitol+cinacalcet treatment groups results were comparable, while only the IV paricalcitol cohort's PTH level, weekly dosage, and cost decreased significantly from the first to the fourth survey (p=0.020, p=0.012, and p=0.0124, respectively). Total costs per week of treatment (including calcium-based phosphate binder and sevelamer) were significantly lower in the paricalcitol vs paricalcitol+cinacalcet cohort (p<0.001). Major limitations of this study are related to the survey design: not controlled and lack of comparability between cohorts; however, reflective of true practice patterns. CONCLUSIONS: The IV Paricalcitol cohort had significantly lower treatment costs compared with patients treated with paricalcitol+calcimemtics (p<0.001), without a significant difference in terms of baseline severity and PTH control.

Prices and distribution margins of in-patent drugs in pharmacy: a comparison in seven European countries.

OBJECTIVES: To compare prices of in-patent active ingredients (AIs) in Europe at three levels (ex-factory prices, net distribution margins and third party payers' prices). METHODS: We compared the prices in seven EU countries (Belgium, France, Germany, Italy, the Netherlands, Spain and the UK) of the 20 in-patent AIs most sold on the Italian retail market in 2004, based on "sell in" sales data. We calculated the average ex-factory price per unit of each compound in each of the seven countries, weighted by the volumes of all reimbursable package sizes and strengths. We estimated net distribution margins according to the 2004 domestic regulations by deducting any type of mandatory discount. Finally, we added VAT to calculate "third party payer's prices". All prices were expressed in index numbers (Italy=100). RESULTS: Italy had the lowest average ex-factory prices, the Netherlands and particularly the UK had by far the lowest distribution margins, while Germany had by far the highest third party payers' prices. The Netherlands and particularly UK showed a steep decrease from ex-factory to third party payers' prices, while Belgium, Italy and Spain gave the opposite pattern. CONCLUSIONS: Our study suggests that public authorities can deal with drug prices both by strictly controlling ex-factory prices and by establishing appropriate distribution margins. The latter might be facilitated by liberalizing the distribution sector.

Medical costs of chronic musculoskeletal pain in Italy.

BACKGROUND AND OBJECTIVES: Musculoskeletal system problems are responsible for more than two-thirds of painful conditions in primary care. However, only one published study, conducted in Finland, has analysed the costs of managing musculoskeletal pain as a whole in primary care. This study analysed the costs of diagnosing and treating chronic musculoskeletal pain in primary care in Italy. A secondary aim of the study was to assess the impact of different drug treatment patterns on medical costs associated with musculoskeletal pain. METHODS: Chronic pain of musculoskeletal origin was defined as continuous or recurrent pain persisting over 3 months with involvement of the musculoskeletal system, i.e. arising from primary musculoskeletal disorders or from the late consequences of external events (injuries, medical care or surgery). A total of 52 general practitioners (GPs) recruited 581 patients. We focussed on the differences between patients treated (410) and not treated (171) with drugs. Within the treated group, we also analysed subgroups given non-selective NSAID-based therapy (subgroup A, 169 patients) or cyclo-oxygenase-2 (COX-2) inhibitor-based therapy (subgroup B, 52 patients). RESULTS: The annual average cost of treating a patient with chronic musculoskeletal pain was euro 212.60. Hospital admissions and GP consultations were the largest cost components, both accounting for around a quarter of the total cost. Not surprisingly, the treated group included older patients, who had more co-morbidities and more severe pain. This was associated with annual costs more than four times those of untreated patients (euro 274.50 vs euro 63.90, respectively). Subgroups A and B did not differ with respect to major demographic and clinical variables except in relation to mean age (63 vs 70 years, respectively; p=0.037). They had similar per-patient costs (euro 186.20 vs euro 172.90), although these totals comprised a different mix of components. CONCLUSION: The analysis showed that the annual average cost of treatment of chronic musculoskeletal pain in Italy varied considerably depending on whether drug treatment was used. COX-2 inhibitors and traditional NSAIDs had similar per-patient costs, although this similarity stemmed from a different mix of components.

Pricing and reimbursement of in-patent drugs in seven European countries: a comparative analysis.

The main objective of this comparative analysis was to assess regulations applied by EU governments to reward potentially innovative drugs. We focused on the pharmaceutical policy for in-patent drugs in seven EU countries: Belgium, France, Germany, Italy, the Netherlands, Spain, and the UK. A common scheme was applied to all seven countries: first, pricing and reimbursement procedures for new and innovative drugs were investigated; secondly, we focused on the use in the regulatory process of economic evaluations. The analysis involved reviewing the literature and interviewing a selected panel of local experts in each country. According to our comparative analysis, a first sensible step might be to classify active ingredients as those addressing neglected pathologies and those for diseases that are already successfully treated, thus offering more limited therapeutic gains by definition. A reasonable solution to reward real innovation could be to admit a premium price for very innovative drugs according to their estimated cost-effectiveness. New drugs with modest improvement could be grouped in therapeutic clusters and submitted to a common reference price, despite patent expiration. Such a "dual approach" could be a sensible compromise to restrict pharmaceutical expenditure while at the same time rewarding companies that invest in high-risk basic research.

Direct medical costs unequivocally related to diabetes in Italian specialized centers.

This study estimated the resource utilization and direct medical costs in Italian diabetes centers (DCs). Hospital admissions for major chronic complications were not considered since DCs deliver primary care and follow up only complications unequivocally related to diabetes-acute complications and diabetic foot. The multicenter, prospective, observational study involving 31 Italian DCs included a total of 1,910 patients classified into eight prognostic groups by type of diabetes (types 1 and 2), metabolic control (HbA1c >7.5%, HbA1c < or =7.5%) and age (< or =60, >60). The average total cost of type 1 diabetes per patient per year ranged from 762 euro in group 2 (age < or =60, HbA1c >7.5%) to 1,060 euro in group 4 (age >60, HbA1c >7.5%), and that the cost of type 2 diabetes from 423 euro in group 5 (age < or =60, HbA1c < or =7.5%) to 613 euro in group 8 (age >60, HbA1c >7.5%). The study brought to light the wide variability in the single cost components across clinically defined groups of patients. The cost of diabetes management in the strict sense was significantly affected by the type of diabetes and metabolic control.

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.

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

PURPOSE: To investigate the costs of epilepsy from a nationwide survey comparing adult patients included in different prognostic categories. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Economic evaluations in Italy: a review of the literature.

OBJECTIVES: To review the economic evaluations (EEs) done in Italy by Italian authors, following a common scheme to allow some comparisons of the studies selected and with the international reviews. METHODS: We selected all the original studies published by Italian authors (in Italian or English) in national and international journals. The period considered was January 1994 to December 2001. Both full and partial economic evaluations were included. Three international databases were interrogated: MEDLINE, Embase, and HealthStar; further articles were added from the internal database of our center (CESAV), which also classifies Italian local publications and journals specialized in health economics. RESULTS: A total of ninety-nine studies were reviewed. More than half of the fifty-seven full EEs focused on drugs as type of intervention (n = 38), followed by diagnostic screening (n = 7). The NHS viewpoint was the most used (n = 55 studies), followed by that of society (n = 27) and hospitals (n = 12). Sixty-eight studies only analyzed direct costs and twenty-nine included both direct and indirect costs. Twenty-five of the thirty-eight pharmacoeconomic full EEs were sponsored by companies. In sixteen of the twenty-five sponsored studies, the sponsor's products were the dominant alternative. CONCLUSIONS: The review showed that, in Italy, like elsewhere, there is a gap between theory and practice in EEs, and sponsors can considerably affect the results of EEs.

The stoma appliances market in five European countries: a comparative analysis.

This comparative exercise analysed the domestic market for stoma appliances in five European countries--Denmark, France, Germany, Italy and the United Kingdom. National legislation, prescription procedures, delivery modalities and the market were investigated in each country. The analysis involved reviewing national and international literature on stoma appliances and interviewing a selected expert panel of market operators in each country comprising at least one health authority representative, one distributor of medical devices and one manufacturer. No specific relationship was found between the health care system framework and the stoma market, except for a greater inclination towards home care in national health services. All five countries reimburse stoma bags, but the distribution of these appliances varies widely, ranging from Denmark, where home delivery is mandatory, to Italy, where any channel can be used. The comparative analysis underlined two important features of the stoma bag market: the discretion of enterostomists in directing patients towards a specific brand of bags, and the patients' high brand loyalty. Despite that, the analysis did not identify any single country that could be considered a benchmark for stoma bag regulation. Each country deals with stoma appliances in different ways, making this a very fragmented market.