Response to clarification letter 2响应于澄清函2.pdfVIP

Single Technology Appraisal – Bevacizumab in combination with oxaliplatin and either 5FU or capecitabine for the treatment of metastatic colorectal cancer PART 2 – RESPONSE TO NON-PRIORITY ERG CLARIFICATION QUESTIONS B15 Could you please clarify the following points regarding the economic analysis • Section 7.2.9. Please provide 95% confidence intervals for the mean dose values in Table 29 p133 and mean number of cycles per month observed in Table 33 p137. In addition, please provide for each of the six treatment groups separately. Tabulated below are the mean dose and cycle durations with confidence intervals as requested. The cycle durations for the bevacizumab arms are based on the mean bevacizumab cycle durations and the cycle duration for all the other arms are based on the oxaliplatin cycle duration. Cycle duration was similar when using oxaliplatin doses as when using bevacizumab for the bevacizumab containing arms. (see footnote to table 2 below). The confidence intervals for the cycle durations were calculated based on a sample size (n) of the total number of cycles. This assumes independence between cycles, which may under estimate confidence intervals. In the economic model the mean per cycle dose was calculated by dividing the mean dose by the mean number of cycles. The updated table below shows the mean dose per each cycle calculated directly from the patient level data, which was calculated as part of the exercise for calculating the confidence intervals for the dose. Hence there is a slight variance between the mean values presented here and the mean values used in the economic model. The only variances however greater than 1% between the figures used in the model and those presented in the table below are for capecitabine and oxaliplatin. We can confirm that updating the model with the mean values presented below does not materially af