http://repub.eur.nl/res/aut/48720/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/38999/ 2013-01-01T00:00:00Z The objective of this study was to assess the potential for cost-effectiveness of new technologies for chronic obstructive pulmonary disease (COPD) over the period from 2001 to 2010. Methods Lung function outcomes and drug prices were observed for a UK COPD population over the period from 2001 to 2010. Cost-effectiveness was assessed at regular intervals on the basis of an established cost-effectiveness model, and the maximum price a technology providing cure could achieve under the current cost-effectiveness rules was estimated. Results The results of this study show that although the scope for clinical improvement in COPD was still considerable, during the 10 years studied, the potential for cost-effectiveness at each point in time was dependent on momentary market characteristics, such as the changing price of comparators and improvements in clinical effectiveness. As a result, the analysis demonstrates that the future cost-effectiveness of a technology in development depends on the manner pricing and clinical effectiveness evolve throughout time. Conclusions Because any predictions will be short-lived and dependent on a number of uncertain factors, we conclude that producing accurate forecasts on the potential for cost-effectiveness of new therapies earlier during the development process is especially difficult under the current static cost-effectiveness framework. http://repub.eur.nl/res/pub/34926/ 2012-03-01T00:00:00Z Objective: When comparators' prices decrease due to market competition and loss of exclusivity, the incremental clinical effectiveness required for a new technology to be cost-effective is expected to increase; and/or the minimum price at which it will be funded will tend to decrease. This may be, however, either unattainable physiologically or financially unviable for drug development. The objective of this study is to provide an empirical basis for this discussion by estimating the potential for price decreases to impact on the cost-effectiveness of new therapies in hypertension. Methods: Cost-effectiveness at launch was estimated for all antihypertensive drugs launched between 1998 and 2008 in the United Kingdom using hypothetical degrees of incremental clinical effectiveness within the methodologic framework applied by the UK National Institute for Health and Clinical Excellence. Incremental cost-effectiveness ratios were computed and compared with funding thresholds. In addition, the levels of incremental clinical effectiveness required to achieve specific cost-effectiveness thresholds at given prices were estimated. Results: Significant price decreases were observed for existing drugs. This was shown to markedly affect cost-effectiveness of technologies entering the market. The required incremental clinical effectiveness was in many cases greater than physiologically possible so, as a consequence, a number of products might not be available today if current methods of economic appraisal had been applied. Conclusions: We conclude that the definition of cost-effectiveness thresholds is fundamental in promoting efficient innovation. Our findings demonstrate that comparator price attrition has the potential to put pressure in the pharmaceutical research model and presents a challenge to new therapies being accepted for funding. Copyright http://repub.eur.nl/res/pub/32947/ 2011-04-01T00:00:00Z Limited healthcare budgets result in payers adopting policies at national, regional or local level to achieve allocative efficiency in drug spending. Some of these aim at creating a link between pharmaceutical prices and the value they provide by setting a cost effectiveness (CE) threshold as the maximum acceptable ratio between incremental costs and effects of new drugs. The clinical effectiveness of the comparator used in those CE analyses tends to be greater over time, whilst, due to market competition and loss of exclusivity, their price is expected to be lower. At the same time, research and development (R&D) costs increase with inflation and with efforts to address regulation towards increased safety concerns. As effective patent times decrease, a minimum price constraint raises for the new entrant. These features occur at different rates across disease areas and are expected to result in differently shaped innovation curves. In this scenario, we demonstrate that a general arbitrary threshold may prevent further efficient R&D. Investment may be withdrawn before the optimum innovation point is reached and affordable clinical effectiveness may be lost. We conclude that disease-specific characteristics are an additional consideration in CE decision rules to accommodate the particularities of innovation across disease areas.