Pricing of pharmaceuticals (original) (raw)
Related papers
2005
Objectives: It has long been suggested that, whereas the results of clinical studies of pharmaceuticals are generalizable from one jurisdiction to another, the results of economic evaluations are location dependent. There has been, however, little study of the causes of variation, whether differences in study results among countries are systematic, or whether they are important for decision making. Methods: A literature search was conducted to identify economic evaluations of pharmaceuticals conducted in two or more European countries. The studies identified were then classified by methodological type and analyzed to assess their level of variability and to identify the main causes of variation. Assessments were also made of the extent to which differences in study results among countries were systematic and whether they would lead to a different decision, assuming a range of values of the threshold willingness-to-pay for a life-year or qualityadjusted life-year (QALY). Results: In total 46 intercountry drug comparisons were identified, 29 in multicountry studies and 17 in comparable single country studies that were considered to be sufficiently similar in terms of methodology. The type of study (i.e., trial-based or modeling study) had some impact on variability, but the most important factor was the extent of variation across countries in effectiveness, resource use or unit costs, allowed by the researcher's chosen methodology. There were few systematic differences in study results among countries, so a decision maker in country B, on seeing a recent economic evaluation of a new drug in country A, would have little basis on which to predict whether the drug, if evaluated, would be more or less cost-effective in his or her country. Given the extent of variation in cost-effectiveness estimates among countries, the importance of this for decision making depends on decision makers' thresholds in willingness-to-pay for a QALY or life-year. If a costeffectiveness threshold (i.e., willingness-to-pay) for a lifeyear or QALY of $50,000 were assumed, the same conclusion regarding cost-effectiveness would be reached in most cases. Conclusion: This review shows that cost-effectiveness results for pharmaceuticals vary from country to country in Western Europe and that these variations are not systematic. In addition, constraints imposed by analysts may reduce apparent variability in the estimates. The lessons for inferring generalizability are not straightforward, although the implications of variation for decision making depend critically on the cost-effectiveness thresholds applying in Western Europe.
Health research policy and systems / BioMed Central, 2015
Coverage decisions determining the benefit baskets of health systems have been increasingly relying on evidence regarding patient benefit and costs. Relevant structures, methodologies, and processes have especially been established for pharmaceuticals but approaches differ. The objective of this work was thus to identify institutions in a broad range of European countries (n = 36) in charge of determining the value of pharmaceuticals for pricing and reimbursement purposes and to map their decision-making process; to examine the different approaches and consider national and supranational possibilities for best practice. Institutions were identified through websites of international networks, ministries, and published literature. Details on institutional practices were supplemented with information from institution websites and linked online sources. The type and extent of information available varied considerably across countries. Different types of public regulatory bodies are invo...
Economic Evaluation for Pricing and Reimbursement of New Drugs in Spain: Fable or Desideratum?
Value in Health, 2020
Background: The economic evaluation of healthcare technologies has become in many countries a basic tool for reimbursement, pricing and purchasing decisions. Objective: The objective of this article is to examine the institutional, legal, and political factors that have impeded the application of economic evaluation and the criterion of efficiency in the process of pricing and reimbursement of new medicines in Spain. Methods: Narrative description of the current institutional framework for the use of economic evaluation in pricing and reimbursement in Spain, legal and policy framework in the field of evaluation of new medicines, and stakeholder initiatives and policies related to the use of economic evaluation outside of the pricing and reimbursement process. Results: Spain has an institutional framework created and established over the last years that could have facilitated a formal use of economic evaluation in the process of pricing and reimbursement. Nevertheless, the real use of economic evaluation at the central or regional level is still unknown, although application of the efficiency criterion, linking to cost-effectiveness, has been clearly required by Spanish laws and regulations at the national level. We highlight a certain degree of moral hazard from the central government that is not directly responsible for the budget impact of reimbursement and pricing decisions. There are currently a number of ongoing initiatives in the field of economic evaluation by various agents, but they remain uncoordinated. Conclusions: Poor governance at the highest level of decision making is the main reason for the lack of interest in economic evaluation. A profound political change, supported by transparency and accountability, is required before the criterion of efficiency can be fully considered in the process of pricing and reimbursement of new medicines in Spain.
Pharmaceutical Pricing in Europe: Weighing up the Options
International Social Security Review, 2006
Rising healthcare costs, particularly pharmaceutical expenditures, have led to the implementation of several pharmaceutical pricing regulations and policies throughout the world. This paper undertakes a critical review of current policies, along with a discussion of alternatives for both on-patent and off-patent drug pricing mechanisms. Traditional direct and indirect price controls have failed to balance the objectives of efficiency and equity. Direct price controls do not restrain growth of costs and may not address the need for innovation. Indirect price controls fail to contain costs and do little to create a competitive off-patent pharmaceutical market. For the on-patent drug markets, we evaluate the use of profit controls, government purchase or auction of patents and Ramsey pricing. Each of these has its own merit, yet the integration of the often separate price and reimbursement decision-making processes would seem to hold the most promise for governments and purchasers to obtain value for money. This approach could send signals to the industry to help direct research towards clinically relevant areas. A v er age pharmaceutical ex pen di tures in OECD coun tries, as a percentage of to tal healthcare, have risen dra mat i cally in the past two decades-from (an un weighted av er age of) 13 per cent in 1980 to 18.1 per cent in 2003. This rise was ac com pa nied by an in crease in over all healthcare expenditures from (an un weighted av er age of) 6.9 per cent of GDP in 1980 to 8.8 per cent in 2003 (OECD, 2005). Thus, pharmaceuticals are tak ing a bigger slice of an in creas ingly large pie. As a re sult, gov ern ments and health in sur ance funds fo cus much ef fort on find ing po lit i cally ac cept able and economically vi a ble phar ma ceu ti cal cost con tain ment pol i cies. Most countries rely on sup ply-side (pric ing) con trols for cost con tain ment and largely