| Choice of comparator |
| The authors did not explicitly specify the comparator that was used in the evaluation. You, the user of the database, should consider whether the strategy in your own setting results in comparable results as was presented here. |
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| Validity of estimate of effectiveness |
The authors did not report that a systematic review of the literature was performed. Effectiveness of the rasburicase strategy was based on the assumptions from the authors. The results of 2 previously published studies were reported which provided some intermediate outcomes (uric acid and serum creatinine levels). Since further information concerning these studies was limited and information on the relation between these intermediate outcomes and the incidence of HU and TLS was not provided it was not possible to comment on the validity of the results in general.
The authors assumed a 100% reduction of TLS. Furthermore, a 90% reduction of HU related cost was assumed. It was not clear whether this equals a 90% reduction in the incidence of HU during the prevention phase. |
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| Validity of estimate of health benefit |
The estimation of benefits was calculated using the incidence and mortality rates of HU and TLS of current practice and assuming a 100% reduction of TLS-related mortality and a 90% reduction of HU related cost. These results were combined with survival rates, taken from two different sources. The survival rates that were used up to 5 years after diagnosis were based on pooled data from clinical trials from patients with haematological cancer. The authors used the overall survival rates for the calculations and reported that regional and intercountry differences in survival were seen. Since the 10-year survival rates from the UK statistics were based on older cohorts an adjustment was made for the better prognosis of more recent cohorts.
However, based on the assumptions that were used to estimate the effectiveness of rasburicase, the validity of the benefits is difficult to evaluate. |
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| Validity of estimate of costs |
All categories of cost relevant to the perspective adopted were included in the analysis. Current resource use was taken from the chart reviews. Total cost of rasburicase was reported.
However, differences in resource use in other cost categories were presented less transparent.
Prices of local national unit costs were obtained from published official sources in each country.
Cost and quantities were not reported separately. A sensitivity analysis of costs and quantities was not conducted. The price year and currency conversions were not reported. Given these limitations the reproducibility of the results is limited. |
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| Other issues |
| Comparisons of findings of the results with other studies were not reported. The generalisability of the results was discussed. The authors reported that country and disease differences clearly affected the results as was seen in the results from the different countries. However, according to the authors the approach that was used for the data collection was not suitable to provide more detailed information of differences. Further limitations concerned the assumption of the natural life expectancy of patients with AML after 10 years. Any possible limitations as a result of the study design that was used and the assumptions that were made concerning the effectiveness of rasburicase were not considered. Results were not presented selectively and the conclusions reflect the scope of the analysis. |
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| Publications of related interest |
Pui CH, Mahmoud H, Wiley JM, Woods GM, Leverger G, Camitta B et al. Recombinant urate oxidase for the prophylaxis or treatment of hyperuricemia in patients with leukemia or lymphoma. 2001. J Clijn Oncol 19:697-704.
Goldman SC, Holcenberg JS, Finklestein JZ, Hutchinson R, Kreissman S, Johnson FL et al. A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk of tumor lysis. 2001. Blood 97:2998-3003.
Pui CH, Jeha S, Irwin D, Camitta B. Recombinant urate oxidase (rasburicase) in the prevention and treatment of malignancy associated hyperuricemia in paediatric and adult patients: results of a compassionate use trial. 2001. Leukemia 15:1505-1509. |