Gianluigi Casadei

Risk sharing agreements: what lessons from Italy?

Italy is one of the few countries that have matured substantial experience of risk-sharing agreements so far. The first performance-based arrangement was agreed in July 2006, and as of October 2010, eighteen contracts have been in force.The complex management of discount schemes is entirely based on Web registries run by AIFA, the Italian drug agency. The system validates each prescription and automatically requests the hospital pharmacy by e-mail to release the drug. If a patient meets nonresponder criteria, the hospital pharmacist should apply for pay-back to the manufacturer. There are still some important question marks to address. First of all, nonresponders have to be documented by health authorities, otherwise any undocumented nonresponder will be paid as a success. Another question concerns pre-set timing. Although the scientific rationale of the nonresponder criteria for each drug has not been made public, time frames appear too short to allow a reliable assessment. Another question is whether regions, which are financially accountable in Italy for pharmaceutical expenditure, are really able to claw back refunds from manufacturers. Unfortunately here again there are no official figures, and regions do not seem yet able to quantify the amount of pay-back matured in the 4 previous years. The delayed and incomplete availability of pay-back procedures may be one explanation.

Continuing Medical Education in six European countries: A comparative analysis

OBJECTIVE We examined Continuing Medical Education (CME) systems in a sample of six EU countries: Austria, Belgium, France, Italy, Norway, and the UK. The aim of this comparative study was to assess the main country-specific institutional settings applied by governments. METHODS A common scheme of analysis was applied to investigate the following variables: (i) CME institutional framework; (ii) benefits and/or penalties to participants; (iii) types of CME activities and system of credits; (iv) accreditation of CME providers and events; (v) CME funding and sponsorship. The analysis involved reviewing the literature on CME policy and interviewing a selected panel of local experts in each country (at least one public manager, one representative of medical associations and one pharmaceutical manager). RESULTS CME is formally compulsory in Austria, France, Italy and the UK, although no sanctions are enforced against non-compliant physicians in practice. The only two countries that offer financial incentives to enhance CME participation are Belgium and Norway, although limited to specific categories of physicians. Formal accreditation of CME providers is required in Austria, France and Italy, while in the other three countries accreditation is focused on activities. Private sponsorship is allowed in all countries but Norway, although within certain limits. CONCLUSIONS This comparative exercise provides an overview of the CME policies adopted by six EU countries to regulate both demand and supply. The substantial variability in the organization and accreditation of schemes indicates that much could be done to improve effectiveness. Although further analysis is needed to assess the results of these policies in practice, lessons drawn from this study may help clarify the weaknesses and strengths of single domestic policies in the perspective of pan-European CME harmonization.

Health technology assessment: for whom the bell tolls?

One of the oldest definitions of Health Technology Assessment (HTA) was given in 1985 by the Institute of Medicine in USA: ‘‘Any process of examining and reporting properties of a medical technology used in health care, such as safety, efficacy, feasibility, and indications for use, cost, and costeffectiveness, as well as social, economic, and ethical consequences whether intended or unintended’’ [1]. It is worth noting that the term health technology does not refer only to drugs, medical devices, and equipment, but involves any intervention related to prevention, diagnosis, therapy, and management of disorders [2, 3]. A recent, even more comprehensive definition has been developed by the International Network of Agencies of HTA: ‘‘HTA is a multidisciplinary field of policy analysis, which studies the medical, social, ethical and economic implications of development, diffusion, and use of health technology’’ [4]. This clearly states that the primary objective of HTA is to provide policy makers with reliable, documented information on the effectiveness, consequences, and costs of healthcare technologies [5]. Therefore, a vital component of HTA is documented, internationally recognized competence in economic evaluation. In general, HTA can be considered a ‘‘melting pot’’ of different disciplines dealing with various and somewhat contrasting needs [6]. Experts may include epidemiologists, economists, physicians, pharmacists, and health-care managers, brought together under the umbrella of public administration guidance. Since HTA activities often tend to be untargeted, uncoordinated, and without priorities [7], each country should appoint one organization of reference according to European directives [8]. The expected outcomes are recommendations bridging evidence-based medicine, economic evaluation, the experience of professionals, patients’ expectations, and the capabilities of national health-care systems [3, 9, 10]. It is not clear whether HTA has developed so fast ‘‘because of’’ or ‘‘despite’’ its multidisciplinary approach. However, it does appear nowadays to be an internationally recognized process. In 2004, the European Commission and Council of Ministers targeted HTA as ‘‘a political priority,’’ recognizing ‘‘...an urgent need for establishing a sustainable European network on HTA.’’ That led to the establishment of EunetHTA [11], a network of 35 organizations throughout Europe that aims at developing practical tools to transform HTA into useful policy advice for the EU and its Member States. Results are expected to be disclosed in December 2008, i.e., in the next few months. HTA is becoming more and more fashionable in Italy, too. Past experts and newcomers in health economics are actively following the HTA trend. A Google search on ‘‘health technology assessment’’ limited to Italian web sites resulted in about 10,600 references, despite the English wording. After checking only the first references, it is clear that there are many proponents, including industrial associations, pharmaceutical companies, scientific societies, and education providers. This calls for some considerations. The Italian National Health Service (INHS) is required to provide qualified health care, but also to keep costs under tight control. If the key task of HTA is to support public authorities in deciding on INHS coverage of a new technology, it could play a major role in selecting the new expensive technologies that are most likely to have real L. Garattini (&) G. Casadei CESAV, Centre for Health Economics, ‘‘Mario Negri’’ Institute for Pharmacological Research, Ranica (Bg), Italy e-mail: lgarattini@marionegri.it

Management of vaccinations in Italy: a national survey after healthcare regionalization

Abstract Objectives: The main aim of this study was to describe the effects of regional organization and performance in managing vaccinations, in the light of the institutional devolution recently introduced in Italy. Methods: We analysed (1) the general organization of regions for vaccination programmes, (2) the management of four vaccination programmes (combined measles-rubella-parotitis, varicella for children, influenza, and pneumococcal 23-valent for adults). First, we conducted preliminary face-to-face interviews with 16 regional managers of the infective disease prevention departments. Subsequently, we sent them a standardized questionnaire to obtain comparable information on general organization and on the four specific vaccination programmes considered. In all, 14 regions were eventually included. Results: The survey showed a widespread lack of regional staff involved in the management of vaccinations and a geographical variation in the availability of computerized data collection. We recorded poor coverage for varicella and pneumococcal 23-valent vaccinations compared to MRP and influenza. Prices of the four vaccines varied widely among regions, with only a weak correlation between prices and volumes. Limitations and conclusions: The major limitation of the survey was the lack of information available at regional level. The piecemeal diffusion of computerized systems and the widespread lack of sufficient staff should mainly explain this. Economic incentives could be offered to regions that achieve national targets. Such incentives should encourage collaboration between central and regional authorities consistent with institutional trends in regional devolution.

HPV vaccine prices in Italy

In contrast to what was reported in the editorial,1 both the bivalent (Cervarix) and the quadrivalent (Gardasil) vaccines are used in Italy for the campaign against cervical cancer. Most of the 20 Italian regions, which fund and implement vaccination programmes on their territory, ran single tenders to exploit potential competition between the two …

Continuing medical education funding and management in Europe: room for improvement?

The need to keep clinical competence up to date has become more and more important in recent decades, since biomedical science has progressed with a speed never seen before. While the benefits of rapid technological development for society are obvious, fast innovation is inevitably associated with the need for continuous updating by health professionals, who are ultimately responsible for making scientific discoveries available to populations. In this context, continuing medical education (CME) programmes have been rapidly increasing in many developed countries. Although the idea that doctors should attend CME programmes on a regular basis is not questioned, the debate on modalities is still wide open. Questions on whether and to what extent current CME programmes improve physicians’ performance and healthcare outcomes are hard to answer, because of the weaknesses in the reported validity and reliability of evaluation methods. The accreditation of medical education and communication companies and the way CME courses should be organised and financed raises controversy too. In many countries their funding mostly stems from commercial support by pharmaceutical companies and medical device manufacturers, casting doubts on the integrity of their real educational function. The situation in Europe, compared to the USA, is complicated by factors such as multiple languages and the mixed roles of public authorities and medical associations. A major concern is the lack of common European rules and quality criteria for CME. In order to understand how CME is organised in Europe and to envisage desirable future trends, we tried to compare the main country-specific institutional settings in Europe, and then formulated suggestions for speeding up the progress of CME.