Page 85 - Htain Manual
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state, the overall cost is computed. This is continued till all the patients have reached the

               terminal stage or died – i.e. lifetime study horizon. Each HCC patient in respective health state

               for a given cycle length.

                       This  exercise  is  performed  for  both  the  scenarios,  i.e.  sorafenib  and  BSC.  Finally,

               incremental  cost-effectiveness  ratio  is  computed  as  the  ratio  of  difference  in  costs  and

               difference in benefits.


               Conclusion
                       Overall, an economic evaluation needs measurement on costs and effects for two or

               more possible alternatives which are being compared. In order to do so, piggy-backing an

               epidemiological  RCT  study  which  is  being  conducted  to  estimate  efficacy  is  one  option.

               However, as we discussed, a RCT may have limitations in many contexts to generate robust

               evidence for an EE. As a result, decision models usually become imperative. However, it needs
               to be recognized that decision models are not free of inaccuracy. These decision models can

               lead to erroneous findings due to several reasons – firstly, if the model structure if incorrect

               and is not biologically plausible, then it leads to incorrect outputs. Secondly, a model is as
               good as the values of parameters which are fed to generate output. Hence, any uncertainty

               in the values of these parameters can lead to uncertainty in estimate of the incremental cost-

               effectiveness ratio (ICER i.e. Ratio of the difference of the costs and the benefits of the two

               interventions being studied). As a result, just as the 95% confidence interval is computed

               around the estimate found in a RCT, it calls for a sensitivity analysis in a decision-model based
               EE to compute 95% confidence intervals. Subsequently, it needs to be assessed whether the

               null value for the ICER lies within the 95% bounds. Thirdly, the population group which is

               considered in a decision model may not be representative of certain population groups. Sub-
               group analysis is the way forward in such situations.


                       To conclude, one can say that each methodology has certain limitations. However, the

               decision modelling can overcome several limitations of a RCT based EE. As a result, there is a

               trend towards EE which are done using a decision model alone, or using a decision model
                               5
               alongside a RCT  . Such as decision model would need evidence for parameters, which could
               be limited. However, the key would be to use as much robust data to parameterize the model

               and then take a decision. After all, a policy maker or program manager or a clinician can have

               two options to make a decision about the appropriate intervention – either wait for the best

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