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56 Economic model TABLE 30 Mean hazard and associated transition probabilities D + P (3-weekly) D + P (weekly) M + P Cycle Hazard Probability Hazard Probability Hazard Probability 1 0.0070 0.0070 0.0058 0.0057 0.0074 0.0073 2 0.0134 0.0134 0.0126 0.0126 0.0153 0.0151 3 0.0178 0.0176 0.0179 0.0177 0.0210 0.0207 4 0.0214 0.0211 0.0225 0.0222 0.0258 0.0255 5 0.0245 0.0242 0.0266 0.0263 0.0302 0.0297 6 0.0273 0.0270 0.0305 0.0301 0.0341 0.0336 7 0.0299 0.0295 0.0342 0.0336 0.0379 0.0371 8 0.0323 0.0318 0.0376 0.0369 0.0414 0.0405 9 0.0346 0.0340 0.0409 0.0401 0.0447 0.0437 10 0.0368 0.0361 0.0441 0.0432 0.0478 0.0467 11 0.0388 0.0381 0.0472 0.0461 0.0509 0.0496 12 0.0408 0.0400 0.0502 0.0490 0.0538 0.0524 TABLE 31 Indirect hazard ratios versus D + P (3-weekly) Intervention HR Ln (HR) SE Distribution D + E 1.053 0.051 0.142 Normal D + E + P (70) 1.237 0.213 0.338 Normal D + E + P (35) 1.132 0.124 0.159 Normal SE, standard error. TABLE 32 Indirect hazard ratios versus M + P Intervention HR Ln (HR) SE Distribution P 1.01 0.010 0.098 Normal M + P + C 1.054 0.052 0.151 Normal SE, standard error. converted in order to obtain the required transition probability. Quality adjustment (QALYs) In order to estimate QALYs, it is necessary to quality adjust the period during which the average patient is alive within the model using an appropriate utility or preference score. Ideally, utility data are required which quantify the potential health status of patients with mHRPC (as opposed to prostate cancer more generally) and which can be used to quantify the impact of the different treatment regimens in terms of their impact on QoL, that is, adverse events and/or palliative benefits. In the absence of suitable utility values identified in the clinical effectiveness and cost-effectiveness review, we conducted a separate review of other potential sources which could be used to inform this part of the economic analysis. Methods For the assessment of QoL, a separate systematic search of relevant databases was undertaken. Full details of the search strategy are reported in the section ‘Cost-effectiveness’ in Appendix 1 (p. 110). After removing duplicates, 205 potential references were identified. Two reviewers independently screened the titles and abstracts of the studies identified from all searches and sources. A full paper copy of any study judged to be relevant by either reviewer was obtained where possible. Fourteen abstracts were identified which were deemed potentially to provide relevant utility values for the QoL of patients with mHRPC. These 14 records were ordered as full papers. All the full articles received were subsequently screened for the presence of relevant prostate
cancer QoL estimation. Studies which did not report any QoL values for metastatic disease were subsequently excluded. Seven studies were identified which reported potentially suitable QoL utility values. The main QoL data reported in the studies were extracted and are reported in detail in Appendix 10, together with a detailed summary of the methods and results for each study. These data are also presented in a summary results table and graphically as a spectrum of utility values for patients with prostate cancer. The summary results table is used to compare the valuation method, source of valuations and the values reported (and definitions) of the different prostate cancer health states considered. The spectrum of utility values for the HRQoL of patients with prostate cancer is used to provide a visual representation of where the different utility values reported for the health states lie on a scale representing the spectrum of prostate cancer (i.e localised, metastatic and mHRPC). Although this scale is subjective, it does help to try to contextualise the different estimates. Results The summary results and the spectrum of HRQoL’s utility values of patients with prostate cancer, based on the seven studies, are presented in Table 33 and Figure 5, respectively. The range of values identified demonstrated considerable variation, ranging from 0.05 to 0.92. One of the main issues with these articles was to establish a correspondence between the different clinical health state descriptions. Effectively, each study has described the prostate cancer health states using different approaches (e.g. alternative health state descriptions, different valuation methods and different sources of values). To compound this problem, the range of values identified included values reported across the entire spectrum of prostate cancer (i.e. not just for mHRPC). Presenting these results graphically, in terms of the spectrum covering the major health states for prostate cancer, enables some of this variation to be explained by the stage of disease to which these values relate. Figure 5 illustrates that the range of values identified for metastatic disease (ranging from between 0.58 to 0.05) demonstrates less variation than the entire range of values considered across the whole disease spectrum. However, clearly the values reported for mHRPC still displayed significant variation, in terms of both the approach used to derive these values and the values themselves. As such, the question of what constitutes a reliable measure of © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Health Technology Assessment 2007; Vol. 11: No. 2 utility for this patient population needs further consideration. Each of these studies is summarised briefly below in order to assess the appropriateness of the values reported in each for the purpose of the economic model. The study by Bennet and colleagues assessed three separate health states in metastatic prostate cancer. 73 Valuations were provided by physicians (n = 43) and patients with both localised (n = 27) and metastatic cancer (n = 17) using a time tradeoff (TTO) approach. The results showed that physicians appeared more optimistic about the QoL outcomes, associated with the different states, than the patients and hence provided higher valuations for each of the states considered. In the first study by Chapman and colleagues, 59 patients with localised or metastatic prostate cancer evaluated three separate prostate cancer health state descriptions, including one state representing localised prostate cancer (state A) and two states based on different severity levels for metastatic prostate cancer (B = moderate, C = severe). 74 TTO valuations were obtained from either a personal (n = 28) or impersonal (n = 31) description of the health states. The results are difficult to interpret since several changes were applied to the health state descriptions used during the course of the study. In the second study reported by Chapman and colleagues, 57 patients with localised or metastatic prostate cancer evaluated three separate prostate cancer health state descriptions, including one state representing localised prostate cancer (state A) and two states based on different severity levels for metastatic prostate cancer (B = moderate, C = severe). 75 TTO valuations were obtained from either a personal or impersonal description of the health states. These were combined when the final results were presented, hence it is difficult to assess the potential impact of the different descriptions on the overall valuations provided. In the study by Krahn and colleagues, 141 prostate cancer patients assessed two main health states representing different stages of prostate cancer: non-metastatic and metastatic disease. 76 Differences between the community and patients preferences were assessed using patient valuations [from rating scale (RS) and standard gamble (SG) approaches] and community valuations [from Health Utilities Index (HUI) and Quality of Well Being Scale (QWB)]. The results demonstrated that patients appeared to value their current health state (either metastatic or non-metastatic 57
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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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List of abbreviations ASCO American
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xvi Executive summary of study desi
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xviii Executive summary prednisone/
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Description of underlying health pr
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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 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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Page 116 and 117: 96 References 251. Scholz MC, Guess
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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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