Health economics analysis
GHD
SECONDARY, GHD
The health economics analysis has two specific aims. The first is to assess the cost-effectiveness of GH discontinuation in the early re-testing scenario by estimating the cost per percentage of children achieving TH of GH − compared to GH + over a 12-month period, and the second is to assess the cost-effectiveness of the new care pathway (early re-testing) compared to traditional care (late re-testing).To assess the cost-effectiveness of no GH therapy (GH −) compared to GH therapy (GH +) in patients with GHD reversal, a cost-consequence analysis will initially be reported, describing all the important results relating to resource use, costs and consequences. Subsequently a trial-based cost-effectiveness analysis will be undertaken from an NHS/personal social services (PSS) perspective to determine the cost per percentage achieving TH of GH − compared to GH + over a 12-month period.Resource use information will be obtained on all healthcare utilisation (primary care and secondary care) and will be obtained mainly from participant questionnaires. Unit costs will be obtained from standard sources and healthcare providers including the British National Formulary (BNF), PSSRU publication on Unit Costs of Health and Social Care and NHS Reference costs.Mean costs and outcomes will be estimated for both the no GH therapy (GH −) and GH therapy (GH +) arms. Cost data are likely to be skewed; therefore, non-parametric comparison of means (e.g. bootstrapping) will be undertaken. Multiple imputation techniques will be used to deal with missing costs, in order to ensure that all eligible trial participants are included in the analysis.Incremental cost-effectiveness ratios (ICERs) will be calculated, and cost-effectiveness acceptability curves will be presented to estimate the probability that GH − is cost-effective for different willingness to pay thresholds.The second objective of the health economics analysis is to determine the cost-effectiveness of the new care pathway (early re-testing) compared to traditional care (late re-testing) using a decision analytic modelling approach. The model will determine the cost per percentage achieving TH and cost per additional quality-adjusted life year (QALY) gained for the intervention (early re-testing) and usual care arm (late re-testing).Data from the main trial and other published sources will be used to populate the model. An incremental cost-effectiveness analysis will determine the cost per percentage achieving TH and an incremental cost-utility analysis will be undertaken to estimate the cost per QALY gained. Both analyses will be conducted from an NHS perspective. Deterministic sensitivity analysis will be undertaken to assess the impact of changing the values of key parameters. Uncertainty in the confidence to be placed on the results of the economic analysis will be explored by conducting a probabilistic sensitivity analysis to estimate cost-effectiveness acceptability curves.