http://repub.eur.nl/res/aut/23071/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/39610/ 2013-01-01T00:00:00Z This article's aim is to understand if and how the efforts to accumulate and organize clinical data transformed the regulation of pharmaceutical care. The authors analyze how the employment of databases by collectives of physicians and researchers shape both clinical and policy practice-and thereby reshape the relation between clinical work and policy. Since the late 1990s, Dutch government has supported the development of clinical databases for specific expensive medicines to gain oversight about actual medicine use. To be able to produce evidence for appropriate medicine use, the collectives set regulations in clinical practice. These internal regulations provide a framework for establishing "appropriate medicine use", steering reimbursement decisions. However, internal regulation and policy rules differ in how quickly they can change. While the employment of databases in clinical practices results in a constant adjustment of the protocols, policy makers require the databases to provide for static moments of "proven appropriate medicine use" in order to account for and define a fixed and closed formulary. Subsequently, the employment of the databases did not deliver on the promise of oversight and control due to different clinical and policy requirements. Nevertheless, the databases did stimulate appropriate medicine use and reimbursement in clinical practice. http://repub.eur.nl/res/pub/32751/ 2012-06-26T00:00:00Z In the last three decades governmental policy in prioritization of medicines is increasingly legitimized through the scientization of the decision-making process on the one hand and a separation in policy production and policy execution on the other. The discourse on health care reimbursement decisions has likewise been dominated by increased rationalization and formalization of the decision-making process. Since the early 1990s the Dutch government and arm’s length agencies have undertaken much effort to regulate pharmaceutical care, mainly by emphasizing the role evidence should have in decision-making on the appropriate use of medicines at all levels, from decisions on insurance schemes coverage to prescriptions at the point of care (Commissie Dunning 1991; Gezondheidsraad 1991; College voor zorgverzekeringen 2007). The Dutch government has developed a series of tools to promote rational prescribing – such as professional guidelines authorized by state agencies, real-time monitoring systems and the conditional reimbursement of medicines – aimed at improving the quality and efficiency of care, and enabling the control of pharmaceutical health care expenditure (College voor zorgverzekeringen 2005; Niezen et al. 2007). Despite the rationalisation of decision-making, governmental policymakers still experience difficulties in explaining the foundations for their decisions. Moreover, the execution of the health regulations in daily practice appears to deviate substantially from the intended policy and its underlying principles (Niezen et al. 2007). The Dutch drug reimbursement system is based on a bureaucratic system logic; if rational decision criteria are used, consistent and legitimate decisionmaking has taken place. The definition of formulary lists (medicines eligible for funding) presumes that appropriate medicine use and reimbursement not only can be defined, but subsequently can be implemented in health care provision. Thus, when health care providers prescribe medicines according to the national formulary, appropriate drug use is warranted. However, there is a discrepancy between the decision-making process outcomes and actual practice of medicine prescription and reimbursement. This discrepancy points at potential legitimacy problems which require further research. What work practices can be observed that are supposed to lead to (more) legitimate decision-making? And, if legitimate decision-making can be observed, how does that wear off in clinical practice? Increasing the legitimacy of prioritization decisions might decrease the difference between policy and practice. Making use of a social scientific perspective this thesis analyses the (development of the) infrastructure of the Dutch drug reimbursement decision-making process and health care allocation instruments in order to gain insight in the practice of health care prioritization decision-making and the way this is legitimized. http://repub.eur.nl/res/pub/22719/ 2011-01-01T00:00:00Z Toezicht staat onder immer toenemende belangstelling, of het nu gaat om het toezicht op financiële instellingen, de veiligheid van het vliegverkeer of de gezondheidszorg. De oorzaken hiervan zijn divers maar kunnen deels gevonden worden in het terugtreden van de overheid als uitvoerder van publieke diensten. Om controle te kunnen houden op die diensten zijn de afgelopen decennia grote toezichthoudende organen opgericht, die inmiddels een flink deel van de economie beslaan; volgens sommige berekeningen werken momenteel ongeveer een miljoen mensen in de ‘toezichtsindustrie’ (van Waarden 2006). Daarnaast dringt steeds meer het besef door dat we leven in een ‘risicomaatschappij’ (Beck 1992) die, hoe paradoxaal ook, aanleiding heeft gegeven tot een ‘veiligheidsutopie’ (Boutelier 2002). Risico’s worden steeds minder geaccepteerd en overheden en toezichthouders worden daar in toenemende mate op aangesproken. Deze trend brengt met zich mee dat onderzoek naar het functioneren van toezichthouders sterk in maatschappelijk belang heeft gewonnen. De afgelopen jaren is dan ook internationaal te constateren dat dit onderzoek een hoge vlucht heeft genomen. Ook de inspecties zelf hebben inmiddels onderzoeksprogramma’s opgezet. Dit geldt ook voor de Inspectie voor de Gezondheidszorg (IGZ). Het voorliggende rapport is een verslag van onderzoek naar de effectiviteit van een van de belangrijke toezichtsinstrumenten van de IGZ, het zogeheten Thematisch Toezicht. Middels casestudie onderzoek beoogt dit rapport de vraag te beantwoorden op welke manier het thematisch toezicht effectief kan zijn en voor welk type risicoproblemen deze vorm van toezicht het meest geschikt is. Hiermee probeert het rapport een zowel conceptuele als empirische bijdrage te leveren aan de discussie over het toezicht in algemene zin, en in het bijzonder over het toezicht op en in de gezondheidszorg. http://repub.eur.nl/res/pub/19403/ 2009-01-01T00:00:00Z OBJECTIVES: Research has shown that effectiveness, cost-effectiveness, and severity of illness each play a role in drug reimbursement decisions. However, the role of budget impact in such decisions is less obvious. Policy makers almost always demand a budget impact estimate yet seem reluctant to formally include budget impact as a rationing criterion. Health economists even reject budget impact as a legitimate criterion. For these reasons, it is important to examine its use in rationing decisions, and rationales underlying its use. METHODS: We trace several rationales supporting the use of budget impact through a literature review, supplemented by semistructured interviews with eleven key stakeholders involved in drug reimbursement decisions in the Netherlands. RESULTS: Budget impact arguments are used in certain instances, although policy makers appear uncomfortable with its use because well described rationales still are lacking. In addition, we identify the following rationales to support budget impact as a rationing criterion: opportunity costs, loss aversion, uncertainty and equal opportunity. CONCLUSIONS: Budget impact plays a role in drug reimbursement decisions and has rationales to support its use. However, policy makers do not easily admit that they consider budget impact and are even reluctant to explicitly use budget impact as a formal criterion. A debate would strengthen the theoretical foundation of budget impact as a legitimate criterion in the context of drug reimbursement decisions. Such discussion of budget impact's role will also enhance policy-makers' accountability. http://repub.eur.nl/res/pub/29585/ 2008-04-01T00:00:00Z There are three known criteria that underlie drug reimbursement decisions: therapeutic value, cost-effectiveness, and burden of disease. However, evidence from recent reimbursement decisions in several jurisdictions points to residual, unexplained variables, among which is budget impact. Budget impact refers to the total costs that drug reimbursement and use entail with respect to one part of the health care system, pharmaceutical care, or to the entire health care system, taking into account the possible reallocation of resources across budgets or sectors of the health care system. The economic and equity rationale for carrying out budget impact analyses is opportunity cost, or benefits forgone, measured in terms of utility or equitable distribution, by using resources in one way rather than another. In other words, by choosing to draw down the budget in one way, decision makers forgo other opportunities to use the same resources. Under a set of unrealistic assumptions, cost-effectiveness analysis accounts for opportunity cost while conveying to the decision maker the price of maximizing health gains, subject to a budget or resource constraint. However, the underlying assumptions are implausible, particularly in the context of pharmaceutical care. Moreover, budget impact analysis is more useful to the decision maker than cost-effectiveness analysis if the objective is not to maximize health gains subject to a budget or resource constraint, but to reduce variance in health gains. With respect to equitable distribution, budget impact analyses lay bare the individuals or groups who lose out - those who bear the opportunity cost of spending resources in accordance with one decision rule rather than another. http://repub.eur.nl/res/pub/35701/ 2007-11-01T00:00:00Z In The Netherlands, conditional reimbursement is considered to be a promising approach to achieving more effective and efficient pharmaceutical care. Because of its formal status and nationwide regulation, conditional reimbursement may allow governments to better control medical decision-making. To evaluate the effects of conditional reimbursement on medicine use and its performance as a policy tool, we compared observed volumes of medicine use with expected volumes. In addition, we mapped the annual growth by analysing trends in the volumes of use of all conditionally reimbursed drugs; starting with the year the drug entered the market (using macro-level data). Next we explored five cases in depth (using micro-level data) in order to explore what fraction of individual prescriptions met the requirements. We also performed qualitative research (document analysis, interviews (N = 65)) in order to obtain the stakeholders' perspectives on how the measure functions, as well as to interpret the case studies data further. The findings suggest that conditional reimbursement may be an effective policy instrument, but that several changes are needed to optimize its impact. These changes are predominantly related to transparency (e.g. conditions are set following clear procedures and criteria), legitimacy (conditions should be consistent with criteria for prioritization), feasibility of procedures to control appropriate use, and timely and appropriate commitment of the stakeholders.