Sampling Uncertainty in the Cost-Effectiveness Evaluations and Guidance Given by the Existing Pharmacoeconomic Guideline

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Sampling Uncertainty in the Cost-Effectiveness Evaluations and Guidance Given by the Existing Pharmacoeconomic Guidelines: A Question to Be Considered

VIlrliinr Cnrayanni, PbD Assistant Professor of Biometry, Highest TechndogicalEducational Institute ofdthens. Greece

Kry Words Pharmacoeconomic guidelines;Stochastic CE analyses; Sampling uncertainty Corrrsprnlrncr Addrrrr Vilelmine Curayanni. PhD. Department ofhblic Hygiene, Highest Technological Educational Institute ofdthens, Saint Spyodonos St. 12210 Egaleo. Athens ‘Other methodsfor nonnmal data such as pennutation and Monte Curio tests that are taking their place in the group of bootstrap techniques. as well as nonparametric tests unsuitablefor incremental CE measures,are not discussed in this article.

The objective of this study is to analyze theguidance given by the existing phannacoeconomic guidelines up to the sampling uncertainty. The aim is tofocus on the existing degree of vagueness of guiddines in d e r to facilitate the tasks of those who must base their choices on studies of this kind Afterthe grouping of methods in an appropriate way so that there would be a relative compondence with the guidelines, a selec-

I N T R O O UCTl O N Pharmacoeconomic analyses are being used increasingly as the basis for reimbursing the costs of new drugs. However, the analyses are complex to evaluate and little guidance is given to researchers on exactly how the assessment of the implications of uncertainty should be done. The problem is more serious for the stochastic evaluations, that is, evaluations exclusively using patient-level data. In the next section, the methods to handle the sampling uncertainty in cost effectiveness (CE) analysis are briefly discussed. In the section following that, a comparison is made among 22 pharmacoeconomic guidelines concerning the precision given to sampling uncertainty and the predicted methods of handling this uncertainty. A final section offers a discussion of the issues raised in the article.

METHODS OF HANDLING S A M P L I N G U N CERTAI N T Y The methods of handling sampling uncertainty are briefly presented in Table 1 and have been grouped as follows. First, the category of methods of confidence interval (CI) construction around incremental CE ratios (ICERs) concerns

tion of 22 guidelines was made to study the precision given to sampling uncertainty and the pmferred methods of handling this uncertainty me methods of handling uncertainty have plaidy evolvedin recentyears. Howeve the differentiations in the guidelines concerning this field are considde. ConsequenQ, the tasks of submitters, evaluators, and decision makers h e very difidt.

the cases when uncertainty covers the northeastern quadrant on the CE plane (one therapy is more effective and more costly than the alternative treatment). The normal theory methods comprise (a) methods based on the assumption of normality, including confidence box (1-3), Taylor’s theorem (4-7), confidence ellipse (4,7,8), and Fieller’s theorem (2,6,8-10); and (b) methods based on asympt