3/10/2023 0 Comments Guidance quotes![]() ![]() If there are no clinical studies for a direct comparison with the pharmaceutical being assessed, or if these do not provide sufficient information about the additional benefit, indirect comparisons can be made in the dossier. Indirect comparisons are second best solutions and are only accepted if no single trial of appropriate quality or relevance to the Belgian target population has been performed and under specific conditions regarding the analyses. In this case, indirect comparisons and/or modelling may be required. The comparator defined at the time of the clinical trials may no longer be the relevant comparator at the time of the pharmacoeconomic evaluation. ![]() In some cases, the choice of the comparator will be difficult due to, for instance, changes in prescription behaviour and therapeutic insights over time. “Direct comparisons are preferred over indirect comparisons similarly, effectiveness and long-term or serious adverse event outcomes are preferred to efficacy and short-term tolerability outcomes.” 5 “In the absence of sufficient direct head-to-head evidence and presence of sufficient indirect evidence, indirect comparisons can be considered as an additional analytic tool.” 4 “In the absence of randomized, controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best choice(s) of treatment.” 2, 3 Indirect comparisons can make it possible to estimate the relative efficacy and/or safety of therapies in relation to each other before any direct comparison trials are available.” 18 “In many clinical fields, competing treatments are assessed against placebo and direct comparisons are rare. In such a situation a mixed approach, called a mixed treatment comparison11, in which the results of direct comparisons are compared with those of indirect comparisons, is very useful as it removes or confirms any reservations that one might have about direct comparison trials.” 18 In other cases, the comparator may have been used in ways which are debatable. ![]() Quite often this trial has been designed with a lack of power. “Often only one direct comparison trial is available. ![]() “Mixed treatment comparisons ( MTC), or network meta-analyses, are used to analyse studies with multiple intervention groups and to synthesise evidence across a series of studies in which different interventions were compared…They build a network of evidence that includes both direct evidence from head to head studies and indirect comparisons whereby interventions that have not been compared directly are linked through common comparators.” 6Īccording to the HIQA, a multiple treatment comparison combines direct and indirect evidence to compare a technology to two or more other treatments a network meta-analysis is appropriate for analysing a combination of direct and indirect evidence where there is at least one closed loop of evidence connecting the two technologies of interest, and a Bayesian mixed treatment comparison is appropriate for comparing multiple treatments using both direct and indirect evidence.” 1 “Mixed treatment comparisons, a special case of network meta-analysis, combine direct evidence and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than traditional meta-analysis.” 2, 3 “Multiple-treatments meta-analysis (MTM) is an extension to indirect comparisons that allows the combination of direct with indirect comparisons, and also the simultaneous analysis of the comparative effects of many interventions” 16 “Network analysis will be used to describe a single synthesised analysis in which more than one common reference is used to indirectly compare the proposed drug and its main comparator.” 11 D, and so on, to deliver an internally consistent set of estimates while respecting the randomisation in the evidence.” 13 Rather than pooling information on trials comparing treatments A and B, network meta-analysis combines data from randomised comparisons, A vs. “Indirect and mixed treatment comparisons ( MTC), also known as network meta-analysis, represent a recent development in evidence synthesis, particularly in decisionmaking contexts. “Also called mixed treatments comparison or multiple treatments comparison meta-analysis, network metaanalysis expands the scope of a conventional pair-wise meta-analysis by analyzing simultaneously both direct comparisons of interventions within randomized controlled trials (RCTs) and indirect comparisons across trials based on a common comparator (e.g., placebo or some standard treatment).” 9 ![]()
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