Livio Garattini

The German experience in reference pricing

Price regulation schemes function both as a means for public authorities to contain costs, and as an economic tool to support the national pharmaceutical industry. This twofold contradictory aim of public intervention in pharmaceutical demand and supply makes such pricing schemes difficult to apply. This article concerns the reference price scheme which concerns setting a price cap for each active ingredient, or group of active ingredients considered equivalent according to some feature (e.g. therapeutic effects and chemical structure). In 1989, the reference price scheme for reimbursable drugs was introduced in Germany to reduce pharmaceutical expenditure, which had been steadily increasing in the past. The study investigates the economic effects of introducing reference prices in Germany in order to assess whether this system has been effective in containing public pharmaceutical expenditure. We conclude that the reference price scheme is an effective tool for price control, but cost containment requires further measures.

A Proposal For Italian Guidelines in Pharmacoeconomics

Economic evaluation ofhealthcare programmes is the economists response to the need for rational allocation of scarce resources. Such evaluation could be increasingly important as a decisionmaking tool. The Mario Negri Institute Centre for Health Economics (CESAV), supported by a pool of experts in the field of pharmacoeconomics, therefore believes that it may be useful to develop standard rules for the conduct of pharmacoeconomic studies in Italy. The need for homogeneous studies stems from the growing pressure on public decision makers to compare different healthcare programmes. We focused on 8 key points that can be considered as the framework of any economic evaluation.

The costs of epilepsy in Italy A prospective cost-of-illness study in referral patients with disease of different severity

PURPOSE [corrected] Epilepsy poses a considerable economic burden on society. However, information is insufficient on the comparative costs of different disease varieties. The purpose of this study was to compare the direct costs of epilepsy in referral patients with disease of different severity and duration. METHODS Patients with newly diagnosed epilepsy (NDE), seizure remission (SR), occasional seizures (OS), frequent non-drug-resistant (NDR) and drug-resistant (DR) seizures, and surgical candidates (SC) from 14 epilepsy centers were the target population. All patients were followed prospectively for 12 months and all medical and paramedical contacts for diagnostic and therapeutic services were noted with details, using ad-hoc diaries and semistructured questionnaires. RESULTS The study population comprised 525 consecutive children and adults with partial (68%), generalized (25%) and undetermined epilepsy (4%) as follows: NDE 70; SR 131; OS 108; NDR 101; DR 107; SC 8. Ambulatory visits (mean 2.8 per patient per year) were the leading service in all groups, followed by EEG recordings (1.8) and biochemical assays (1.1). At entry, the commonest drugs were carbamazepine (50%), valproate (37%), phenobarbital (21%), vigabatrin (14%) and lamotrigine (11%). New antiepileptic drugs (AED) were used increasingly with the severity of the disease. The total annual costs varied significantly across groups: 3945 Euro (SC), 2198 Euro (DR), 1626 Euro (NDR), 1002 Euro (NDE), 558 Euro (OS), 412 Euro (SR). The main item of expenditure was hospital stay (including day-hospital), followed by drug treatment and outpatient visits. The costs of outpatient services, hospital services and drugs varied significantly across groups. CONCLUSIONS The direct costs of epilepsy vary significantly depending on the severity of the disease and the response to treatment. Hospital admissions and drugs are the commonest items of expenditure.

Direct Cost of Medical Management of Epilepsy among Adults in Italy: A Prospective Cost-of-Illness Study (EPICOS)

Summary:  Purpose: To investigate the costs of epilepsy from a nationwide survey comparing adult patients included in different prognostic categories.

Costs of diabetes. A methodological analysis of the literature.

AbstractObjective: To review studies on the costs of diabetes and its complications through a scheme designed specifically for assessing the quality of cost-of-illness (COI) studies. Design and Setting: The methodology of COI studies in diabetes was analysed in order to assess the significance of quantitative results. The scheme adopted 7 items identified as the main points for discussing the methodological choices governing the results. We also used a checklist based on questions related to the 7 items. Main outcome measures and results: The answers showed that many studies appear not to give technical details, so it is hard to understand themethod.Methodological choices varied widely between the studies. This is probably due to the lack of consensus on the methodology of COI studies. Based on the findings of this review, we suggest also some specific points that could help produce more reliable results on the costs of diabetes. Conclusions: Clearly, a general consensus on COI studies is still remote, making the value of any comparison of results questionable.

The Burden of Moderate to Severe Psoriasis

Psoriasis is a chronic, immune-mediated skin disorder that affects 1–3% of the general population worldwide. While considered a non-life-threatening disease, psoriasis represents a social and financial burden for patients and the healthcare system. Individuals suffer from disfigurement and from social stigmatization. Because the disease is usually persistent, patients with a diagnosis of psoriasis usually need lifelong care, which also means a lifetime of expenses. We aimed to conduct a comprehensive review of the evidence available concerning the social burden and costs of psoriasis.A search for the keywords ‘quality of life’ (QOL) or ‘burden’ or ‘stigmatization’ or ‘psychological factors’ in PubMed up to January 2010 yielded a total of 817 studies. QOL was affected by psoriasis to a degree comparable with diabetes or cancer. A search for ‘cost-of-illness analyses’, in the same period, yielded only seven papers satisfying entry criteria. All the studies but one were performed before biologics became available for psoriasis treatment. Direct costs were higher than indirect costs, with hospitalization representing the most significant item. Treatment costs showed wide variations between different studies. Reasons for these discrepancies are manifold including differences in the selection of the sample, as well as in the methods for calculating costs. There is a need to harmonize methodologies. For a final conclusive judgement of the cost effectiveness of innovative therapies such as biological agents, long-term economic consequences have to be evaluated and long-term remission rates and complications considered.

The Costs of Childhood Epilepsy in Italy: Comparative Findings from Three Health Care Settings

Summary:  Purpose: To determine the direct costs of epilepsy in a child neurology referral population, stratified by disease, duration, and severity, comparing three different health care settings [i.e., teaching or clinical research (CR) hospitals, general hospitals, and outpatient services].

A Review of the Costs of Managing Childhood Epilepsy

Epilepsy is a chronic treatable condition for which new diagnostic tools and several new drugs and non-pharmacological treatments are now available. The cost profile of these options is assessed here through an overview of the available literature focusing on studies of childhood epilepsy.Several methodological problems arise when interpreting the results of economic studies in epilepsy, including the variability of the study population and costs items, the reliability of the sources of cost, the limitations of the methods of data collection and the deficiencies of the study designs, with reference to the measures of treatment benefits. International comparisons are then difficult because economic results cannot be compared on account of differences in monetary issues, clinical practice patterns and healthcare system frameworks.The economic aspects of epilepsy are different in children and adults. Differences are detectable in the incidence and expression of epileptic syndromes, social and emotional impact, availability of antiepileptic drugs, hospital admissions, diagnostic tests and referral to specialists, social assistants and other healthcare professionals. In addition, children have access to medical services only with the help of a caregiver, for whom there may be lost work days or under-employment.The mean annual cost per child with epilepsy was

Italian risk-sharing agreements on drugs: are they worthwhile?

US1853 for controlled epilepsy and

Economic evaluation of human papilloma virus vaccination in the European Union: a critical review

US4950 for uncontrolled epilepsy in a Spanish study performed in 1998 and the annual direct costs per child with epilepsy ranged from €844 for patients in remission to €3268 for patients with drug-resistant epilepsy in an Italian study done between 1996 and 1998. The Spanish study showed that direct costs are the major source of expenditure for children with epilepsy.These studies along with a number of other cost-of-illness studies in combined populations of adults and children showed that service use and costs increase with more severe forms of illness and seizure frequency, this being more marked in adults than in children. Moderate cost differences may be expected between children (higher) and adults (lower), particularly with reference to initial investigations. Costs of epilepsy are mostly explained by hospital admissions and drugs; in particular, drug costs tend to dominate in more well controlled epilepsy, while both hospital admissions and drugs are significant costs in less well controlled epilepsy. Newly diagnosed patients can incur significant hospital and diagnostic costs. Costs for epilepsy tend to be lower for patients cared for in general practice or outpatient settings than in hospital settings. Seizure control by drugs, ketogenic diet or surgery is associated with a significant reduction in the costs of epilepsy.