D The clinical evaluation suggests that, relative to <the comparator>, <the intervention> has <superior/non-inferior/uncertain/inferior> safety and <superior/non-inferior/uncertain/inferior> effectiveness <based on the evidence profile given in Table 15>. The appropriate economic analysis for the evaluation should therefore have been <refer to appropriate economic analysis in Table 18> (see Table 18). This <was/was not> provided in the submission based assessment Table 18 Classification of the comparative effectiveness and safety of <the proposed therapeutic medical service> compared with <main comparator> and guide to the suitable type of economic evaluation Comparative safety Comparative effectiveness Inferior Uncertaina Non-inferiorb Superior Health forgone: Health forgone: Health forgone need other Inferior need other possible: need other ? Likely CUA supportive supportive factors supportive factors factors Health forgone possible: need ? Likely Uncertaina ? ? other supportive CEA/CUA factors Health forgone: Non-inferiorb need other ? CMA CEA/CUA supportive factors Superior ? Likely CUA ? Likely CEA/CUA CEA/CUA CEA/CUA CEA=cost-effectiveness analysis; CMA=cost-minimisation analysis; CUA=cost-utility analysis ? = reflect uncertainties and any identified health trade-offs in the economic evaluation, as a minimum in a cost-consequences analysis a covers concepts such as inadequate minimisation of important sources of bias, lack of statistical significance in an ‘Uncertainty’ underpowered trial, detecting clinically unimportant therapeutic differences, inconsistent results across trials, and trade-offs within the comparative effectiveness and/or the comparative safety considerations b An adequate assessment of is the preferred basis for demonstrating equivalence ‘non-inferiority’ An economic evaluation should be presented in all assessment reports to be considered by MSAC except when a service is indisputably demonstrated to be associated with net clinical harms to patients (as it is unlikely that MSAC will recommend government subsidy of the service). The SBA presents <a trial-based economic evaluation, based on direct randomised trials only/a stepped economic evaluation, based on direct randomised trials and implementing a modelled evaluation using variables reported in Section C/a modelled economic evaluation based on an indirect comparison of <randomised/nonrandomised> studies>.
D The clinical evaluation suggests that, relative to <the comparator>, <the intervention> has <superior/non-inferior/uncertain/inferior> safety and <superior/non-inferior/uncertain/inferior> effectiveness <based on the evidence profile given in Table 15>. The appropriate economic analysis for the evaluation should therefore have been <refer to appropriate economic analysis in Table 18> (see Table 18). This <was/was not> provided in the submission based assessment Table 18 Classification of the comparative effectiveness and safety of <the proposed therapeutic medical service> compared with <main comparator> and guide to the suitable type of economic evaluation Comparative safety Comparative effectiveness Inferior Uncertaina Non-inferiorb Superior Inferior Health forgone: need other supportive factors Health forgone possible: need other supportive factors Health forgone: need other supportive factors ? Likely CUA Uncertaina Health forgone possible: need other supportive factors ? ? ? Likely CEA/CUA Non-inferiorb Health forgone: need other supportive factors ? CMA CEA/CUA Superior ? Likely CUA ? Likely CEA/CUA CEA/CUA CEA/CUA CEA=cost-effectiveness analysis; CMA=cost-minimisation analysis; CUA=cost-utility analysis ? = reflect uncertainties and any identified health trade-offs in the economic evaluation, as a minimum in a cost-consequences analysis a ‘Uncertainty’ covers concepts such as inadequate minimisation of important sources of bias, lack of statistical significance in an underpowered trial, detecting clinically unimportant therapeutic differences, inconsistent results across trials, and trade-offs within the comparative effectiveness and/or the comparative safety considerations b An adequate assessment of ‘non-inferiority’ is the preferred basis for demonstrating equivalence An economic evaluation should be presented in all assessment reports to be considered by MSAC except when a service is indisputably demonstrated to be associated with net clinical harms to patients (as it is unlikely that MSAC will recommend government subsidy of the service). The SBA presents <a trial-based economic evaluation, based on direct randomised trials only/a stepped economic evaluation, based on direct randomised trials and implementing a modelled evaluation using variables reported in Section C/a modelled economic evaluation based on an indirect comparison of <randomised/nonrandomised> studies>.
MSAC%20Assessment%20Report%20Critique%20Template%20-%20Therapeutic.docx