The lag between effectiveness and cost-effectiveness evidence of new drugs. Implications for decision-making in health care.
ABSTRACT A new drug is approved for use if its efficacy and safety have been demonstrated. However, healthcare decision makers may also require data on the cost-effectiveness of new drugs if they are to make informed decisions about their place in therapy. Cost-effectiveness evidence may lag behind the effectiveness data in terms of its availability. We explored the timeliness of delivering cost-effectiveness information about new drugs with established effectiveness and significant financial impact. Drugs were identified, based on guidance documents and reports published by the UK National Institute for Clinical Excellence (NICE), and the following data were collected: dates of publication of first effectiveness and cost-effectiveness evidence, methodology of the cost-effectiveness analysis, quality scores of the clinical studies. Eighteen guidance documents on the use of new drugs/drug groups published by NICE by October 2001 covered 30 health technologies, which were included in the analysis. The analysis of the evidence showed that their effectiveness had been demonstrated in the last 12 years, with only two exceptions. However, cost-effectiveness evidence had been published for 21 (70%) of the technologies. The cost-effectiveness was estimated in 52.4% of cases using models. The good quality effectiveness evidence lagged behind the first effectiveness evidence by 1.40 years (95% CI 0.57-2.23), while the mean lag between the first effectiveness evidence and the first cost-effectiveness publications was estimated as 3.20 years (95% CI 1.76-4.65). Cost-effectiveness evidence thus often lags behind the effectiveness evidence. As a result healthcare decision makers are sometimes in a position of having to take decisions without having adequate cost-effectiveness data at their disposal.
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ABSTRACT: To examine whether randomized economic evaluations report clinical effectiveness estimates that are unrepresentative of the totality of the research literature. From 36 studies (12,294 patients) of enhanced care for depression, we compared pooled clinical effect sizes in studies with a concurrent economic evaluation to those in studies that did not publish a concurrent economic evaluation, using metaregression. The pooled clinical effect size of studies publishing an economic evaluation was almost twice as large as that of studies that did not publish an economic evaluation (pooled standardized mean difference [SMD] in randomized controlled trials [RCTs] with an economic evaluation=0.34; 95% confidence interval [CI]=0.23-0.46; pooled SMD in RCTs without an economic evaluation=0.17; 95% CI=0.10-0.25). This difference was statistically significant (SMD between group difference=-0.17; 95% CI: -0.31 to -0.02; P=0.02). Publication of an economic evaluation of enhanced care for depression was associated with a larger clinical effect size. Cost-effectiveness estimates should be interpreted with caution, and the representativeness of the clinical data on which they are based should always be considered. Further research is needed to explore this observed association and potential bias in other areas.Journal of Clinical Epidemiology 09/2007; 60(8):781-6. DOI:10.1016/j.jclinepi.2006.10.014 · 5.48 Impact Factor
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ABSTRACT: To investigate the occurrence of the word ;;effectiveness'' in the political-administrative decision-making minutes in specialized healthcare as presented to board and council meetings by top management teams. The occurrence and intended use of ;;effectiveness'' were identified from all council and board meeting minutes (n = 190) of five Finnish university hospital districts in 2001 and 2006. Data were collected from the Internet pages of the hospital districts. For analysis, deductive content analysis combining qualitative and quantitative methodologies was used. The word ;;effectiveness'' occurred in the planning, organization and evaluation of service activities and in the definitions and justifications for the goal states of research and development work. Although objectives were justified by effectiveness, the occurrence and use of the term were not grounded on proven effectiveness but rather represented an ideal being pursued. Use of the word ;;effectiveness'' increased from 2001 to 2006, particularly in the political-administrative decision-making of large hospital districts. This article gives useful information regarding the benefits of effectiveness in political-administrative decision-making. Healthcare is under pressure to increase effectiveness, which is manifested by rhetoric presentations of the term in the political-administrative decision-making in specialized healthcare. There is a need for focused collection and systematic follow-up of easily available effectiveness information in healthcare.Scandinavian Journal of Public Health 07/2009; 37(5):494-502. DOI:10.1177/1403494809106503 · 3.13 Impact Factor
- Journal of Medical Economics 02/2008; 11(3):541-6. DOI:10.3111/13696990802363015