The lag between effectiveness and cost-effectiveness evidence of new drugs: Implications for decision-making in health care
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.
Available from: Reinhard Busse
Available from: Dawn Craig
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ABSTRACT: Health-care technology reviews now increasingly include outcome costs as well as clinical effects. This study reports the findings and implications of a survey to explore the usefulness of the National Health Service Economic Evaluation Database (NHS EED) within this process.
Postal survey of lead authors of Technology Assessment Reviews (TARs) commissioned by the United Kingdom's National Institute for Clinical Excellence (NICE). The questionnaire investigated the usefulness of NHS EED in terms of (a) search strategy, (b) data extraction, (c) quality assessment, and (d) determining requirements for new modeling studies. Qualitative data were requested, including opinions regarding NHS EED.
NHS EED was used in 90 percent of all identified reviews (n = 46). The questionnaire response rate was 63 percent. The percentage of scores 3 or above (most useful), 2 or below (least useful), or N/A were, respectively, (a) search strategy= 62 percent, 23 percent, 15 percent; (b) data extraction = 23 percent, 27 percent, 50 percent, (c) quality assessment= 38 percent, 19 percent, 42 percent; (d) determining requirements for new modeling studies = 27 percent, 23 percent, 50 percent. The results were expanded further in the qualitative data from the respondents.
NHS EED is a useful tool for a variety of tasks in the NICE/TAR process but not, unsurprisingly, as a replacement for understanding primary studies. There is, however, a need to reduce the impact of time lags between the publication of economic evaluations and the appearance of abstracts relating to them on NHS EED. The results will inform future developments of the NHS EED database, which should increase its usefulness to researchers.
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ABSTRACT: In 1998, guidelines for pharmacoeconomic evaluation were issued in Denmark. It was left to the discretion of the industry for which products to submit a pharmacoeconomic study. The impact of this voluntary system is illustrated by a case study on reimbursement of two types of glitazones. A review is presented of the evidence on safety, effectiveness and cost-effectiveness of glitazones that was available in the public domain at the time of reimbursement decision making, which was matched to the Danish criteria for general reimbursement of new pharmaceuticals. The study concludes that the voluntary system has not supported the inclusion of efficiency considerations in reimbursement decision making on glitazones. The decision-making process may be improved by mandatory pharmacoeconomic evaluations for selected products such as glitazones, which potentially represent a benefit to patients and potentially improve the cost-effectiveness of care, while at the same time having a considerable budget impact.
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