Docetaxel with prednisone or prednisolone for the treatment of ...

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46 Economic review TABLE 20 Summary of cost-effectiveness Intervention Mean costs (CAN$) Mean quality- ICER adjusted weeks M + P 27,300 41.5 P 29,000 28.2 Incremental –1,700 13.3 M + P dominates P M, mitoxantrone; P, prednisone. Comments The economic analysis is based on patient-level data from CCI-NOV22, and as such the results are likely to have good internal validity. However, the study does suffer from some potential limitations which affect its applicability for healthcare decision-making within the NHS. First, it is unclear how generalisable the results are to the NHS setting. The study was undertaken in Canada using Canadian practice patterns and the authors suggest that the results should only be generalised to similar healthcare systems. In addition, the report presents total costs per category with no separation between the unit costs and resource use. This further limits the transfer of the results to NHS practice. Second, the analysis undertaken within the study only considers the comparison of mitoxantrone plus prednisone with prednisone/prednisolone alone. Therefore, the analysis ignores other chemotherapies that are potentially relevant to the NHS (i.e. docetaxel and estramustine). Finally, the valuation of benefit undertaken within the analysis involved translating measures of QoL obtained from patient completed questionnaires into a proxy rating scale and then to utilities via a published equation. This does not conform to the requirements of the NICE reference case, which recommend societal valuations obtained using a standardised and validated generic instrument. Company submissions Review of Sanofi-Aventis (2005). 61 Sponsor submission to the National Institute for Health and Clinical Excellence: Taxotere ® (docetaxel) in Metastatic Hormone-refractory Prostate Cancer (mHRPC) Overview The economic analysis in the submission by Sanofi-Aventis evaluated the cost-effectiveness of docetaxel plus prednisone (3-weekly regimen) compared with mitoxantrone plus prednisone. The evaluation was based on an analysis of patient-level data derived from prospective collection of resource use and patient outcome data from the TAX 327 clinical trial. Although TAX 327 included two alternative docetaxel regimens (3-weekly and weekly administration), only the 3-weekly regimen was considered in the cost-effectiveness analysis due to current licensing. The analysis was undertaken from an NHS perspective. Overall costs were separated into two main elements: the first-line chemotherapy phase (comprising the drug acquisition costs, costs of administration and hospitalisations for adverse events) and the follow-up phase (including subsequent chemotherapy, palliative therapies and hospitalisations). The primary outcome for the cost-effectiveness analysis was life-years gained based on a comparison of overall survival in the different intervention groups. Separate life-years gained estimates were provided based on a withintrial comparison (using median survival data) and a lifetime comparison (using mean survival data). The lifetime comparison was based on an extrapolation approach using parametric survival analysis. Decision uncertainty was assessed using simple deterministic sensitivity analysis. A brief summary of the evaluation is provided in Table 21. The key features are described in more detail below. Summary of effectiveness data Survival estimates were based on patient-level data from the TAX 327 trial. Two separate analyses were undertaken: (1) a within-trial analysis – using median survival estimates and (2) a lifetime analysis – based on mean survival duration. In order to estimate mean survival duration, it is necessary to estimate the area under the entire survival curve. In situations in which censoring exists, the survival curves must be extrapolated beyond the observed data to eliminate right censoring. Consequently, a parametric survival model was fitted in order to obtain an estimate of mean survival duration for each of the two interventions.
TABLE 21 Summary of submission by Sanofi-Aventis Author Sanofi-Aventis 61 A Weibull model was applied to the survival data based on a visual check of a plot of log (cumulative hazard) against log (time). A Weibull model is used in situations in which the assumption of a constant hazard with respect to time is not appropriate (i.e. the risk of mortality is increasing/decreasing). Survival analysis was undertaken using PROC LIFEREG in SAS (v9.1). The mean survival was estimated from the output parameters (intercept and scale) using the following equation: © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Health Technology Assessment 2007; Vol. 11: No. 2 Date 2005 Type of economic evaluation Cost-effectiveness Study classification Patient-level data I. Prospective resource use and patient outcome data (type A: RCT) Currency used UK £ Year to which costs apply A unique price year was not given Perspective used UK NHS Timeframe Within trial analysis and extrapolation to lifetime (survival only) Comparators 1. Docetaxel 75 mg/m2 plus prednisone (every 3 weeks) 2. Mitoxantrone 12 mg/m 2 plus prednisone (every 3 weeks) Source(s) of effectiveness data TAX 327 Source(s) of resource use data TAX 327 Source(s) of unit cost data Not stated Modelling approach used Analysis based on patient-level survival and resource use data from TAX 327. Separate analyses conducted for within-trial analysis and lifetime horizon using parametric survival analysis (Weibull distribution) to extrapolate survival data Summary of effectiveness results Median survival from Kaplan–Meier: Docetaxel plus prednisone = 18.9 months Mitoxantrone plus prednisone = 16.5 months Difference = 2.4 months Mean survival based on extrapolation using parametric survival model using Weibull distribution (95% CI): Docetaxel = 22.38 (20.38 to 24.62) months Mitoxantrone = 18.65 (17.30 to 20.12) months Difference = 3.73 months Summary of cost results Total per patient cost was estimated at £15,767 for docetaxel plus prednisone (comprising £8329 for first-line chemotherapy and £7438 for further therapy) and £9711 for mitoxantrone plus prednisone (comprising £1695 for first-line chemotherapy and £8016 for further therapy) Summary of cost-effectiveness results The incremental cost per life-year gained for docetaxel was £30,280 based on median survival data. Using mean survival, estimated using parametric survival methods, the incremental cost per life-year gained for docetaxel was reported to be £19,483 Sensitivity analysis One-way sensitivity analyses were conducted by varying the mean survival difference based on the lower and upper bounds estimated for docetaxel plus prednisone. The ICER ranged from £12,173 to £42,007 per life-year gained mean survival = exp(intercept) × Γ(1 + scale parameter) Table 22 provides a comparison of the alternative analyses based on the different approaches. The results demonstrate that the within-trial analysis, based on median survival (based on the Kaplan–Meier analysis), results in a more conservative estimate of the difference between the interventions (2.4 months) compared with the estimate based on mean survival (3.73 months). 47
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A systematic review and economic mo
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A systematic review and economic mo
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Objectives: A systematic review was
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Glossary and list of abbreviations
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Glossary Absolute risk reduction Th
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Glossary continued Expected value o
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Glossary continued Progression-free
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Page 71 and 72: TABLE 27 Cost-effectiveness results
Page 73 and 74: Introduction The review of cost-eff
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Page 96 and 97: 76 Discussion (CCI-NOV22) and least
Page 98 and 99: 78 Discussion subsequent chemothera
Page 101: Rodolphe Perard received funding fr
Page 104 and 105: 84 References Compendium; 2004. URL
Page 106 and 107: 86 References (D) in patients (pts)
Page 108 and 109: 88 References 100. Aventis Pharma.
Page 110 and 111: 90 References low-dose prednisone i
Page 112 and 113: 92 References 180. Kozloff M, Robin
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96 References 251. Scholz MC, Guess
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Clinical effectiveness Searching fo
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1. Prostatic Intraepithelial Neopla
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19. donataxel 20. doxetal 21. doxmi
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6. Mitozantrone.ti,ab. 7. Mitoxantr
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Texot or Trazoteva or Trixotene or
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1. (docetaxel OR asodecel OR doxeta
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10. (index of wellbeing or quality
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Appendix 2 Excluded studies Study d
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Study details Reason for exclusion
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Meeting: 2004 ASCO Annual Meeting C
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Studies of clinical effectiveness w
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Using the method outlined by Parmar
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Appendix 6 Data extraction tables
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Study details and Participant detai
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158 Appendix 7 Ernst et al. 33 Qual
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Appendix 9 © Queen’s Printer and
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Sanofi-Aventis 61 Bloomfield et al.
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Sanofi-Aventis 61 Bloomfield et al.
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168 Appendix 10 TABLE 51 Mean (SD)
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170 Appendix 10 TABLE 54 Distributi
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172 Appendix 10 TABLE 57 Mean stand
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174 Appendix 11 TABLE 63 Drug and a
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176 Appendix 12 Scenario: moderate
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178 Appendix 13 ● You occasionall
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Members Chair, Professor Tom Walley
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Members Chair, Professor Bruce Camp
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Feedback The HTA Programme and the
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