Health economic analysis
breast cancer
BREAST CANCER, HFRS
The economic analysis will take an NHS perspective to estimate both cost effectiveness (£ per change in HFRS) and cost utility (Incremental £/QALY) as well as a budget impact. QALYs will be estimated from EORTC using the SCHARR algorithm [Costs will include that of the intervention and on any changes in use of NHS services. As the intervention cost might differ between that in the trial and in routine practice, we will take two approaches, one detailing changes in CNS team total time allocations in each arm during the trial and another collecting data on views of both the CNS team and managers on the extent to which the intervention could be incorporated into standard practice (and under what circumstances such as being included in training and in guidelines). While both these costs will be reported, the latter would be more relevant in estimating budget impact if implemented in routine practice. The cost of changes in service use will be based on a customised resource use patient questionnaire at 6 weeks and 6 months.Estimates of both cost and QALY increments will be estimated for each patient and incorporated into the planned statistical analyses described above. If a clinically relevant gain in the primary outcome is found to be statistically significant, more detailed economic modelling will be carried out, to explore uncertainty and to extend the time frame beyond that of the trial. This will build on the recent cost effectiveness modelling for similar interventions for hot flushes in breast cancer [All relevant resource items identified will be costed using published national cost data (British National Formulary and Personal Social Services Research Unit, and NHS reference cost). Accumulated costs and QALYs per patient will be estimated by means of area under the curve. Where appropriate, we will estimate incremental cost-effectiveness ratios (ICERs). We will estimate mean values and 95% percentiles using nonparametric bootstrapping. We will produce cost-effectiveness acceptability curves (CEACs) to illustrate the uncertainty of such estimates. Major assumptions made in the costing and QALYs will be tested by means of sensitivity analyses.