Confirm that all interventions and therapies are appropriately included in the economic evaluation. If any therapies are excluded from the economic evaluation, consider whether the SBA provides adequate justification for the exclusion. Reference the place in Section D where this is discussed in more detail. Describe any differences in the delivery/organisation of care between the intervention and main comparator. If there are differences, then note the strengths and weaknesses of the different models of care. State the clinical claim proposed in the SBA. For example, the intervention has superior safety and effectiveness, relative to the main comparator. If a clinical claim is not provided in the SBA, this should also be stated. PICO If the PICO were not presented to PASC or the MSAC executive, comment on whether the PICO chosen are appropriate.
For example, with regard to Table 15 if consistency was poor (eg high heterogeneity in a a subgroup analysis may be undertaken or referred to in Section C and then modelled in Section D. Example tables and approaches are suggested in the MSAC Therapeutics Guidelines. If the applicability of the evidence to the target Australian population is poor, because the people participating in the studies (in the evidence base) were different, then Section C may require a description of the baseline risk in the Australian population - in the model - can then be multiplied by the relative treatment effects reported in the evidence base. If the applicability of the evidence is poor in terms of the healthcare context, then Section C would need to provide a list and unit costs of the healthcare resource usage likely in the Australian setting. Comment on the results of the pre-modelling studies – are they reasonable? Are they accurate? Do they answer the proposed applicability question? Comment on any variation of treatment claim from Section B. Issues in this section are likely to be related to issues in D.2; avoid excessive repetition. Provide detail on applicability issues NOT identified in the SBA but likely, in the evaluator’s judgement, to be critical for the decision. If the generalisability of the evidence to the Australian population is poor because the trial follow-up was not representative of the use of the intervention in practice (ie an “other consideration” in Table 15), then this is an Extrapolation Translation Issue according to the MSAC Therapeutic Guidelines. Comment on the results of the pre-modelling studies – are they reasonable? Are they accurate? Do they answer the proposed extrapolation question? Comment on any variation of treatment claim from Section B. Provide detail on extrapolation issues NOT identified in the SBA but likely, in the evaluator’s judgement, to be critical for the decision. trial
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>.
For any trial-based outcome relied on in the economic evaluation with any extrapolation from the time horizon of the trial(s) only (Based on corresponding extrapolation of duration of treatment, if any) (From Subsection C.4 if extrapolation is required) (Alternative Step 3a) For any important outcome generated for or by the economic evaluation from the trial-based outcome(s) (‘transformation of nature of outcome’ only) (Include here any modelled increases in the provision of some resources and any modelled offsetting decreases of others) (From Subsection C.4 if possible, or if this approach is used, explain why a presentation here is not possible) (Alternative Step 3a) For the final outcome relied on in the economic evaluation generated as a valuation of the trial-based outcome(s) (‘value transformation’ only) (Should not change from Step 2 because nature of outcome does not change) (From Subsection C.4 if possible, or if this approach is used, explain why a presentation here is not possible) (Alternative Step 3a) For the final outcome relied on in the economic evaluation combining any extrapolation from the time horizon of the trial(s) with any transformation of the outcome(s) (Completed Step 3 and expected base case) XXX (Step 3) > Subsections to the MSAC Therapeutic Guidelines. Comment on the ICER and whether it accurately represents the cost-effectiveness, given the methodology used, of listing the intervention. Consider which step in the economic evaluation appears to contribute most to the final ICER. If the SBA presents Markov traces or other model traces, present those here. If the SBA has not presented model traces and they provide some insight into what is driving the model, then present them here and comment. Comment on whether the model traces make sense – do they correspond to empirical data, or what would be expected with the disease or condition? Has the SBA presented univariate (one-way) sensitivity analyses on all variables using plausible extremes of values, and justified the selection of those extreme values? Has the SBA tabulated all univariate sensitivity analyses alongside the base case?
or on B Additional information or tables relating to Section B should be included here. ID Study Level of evidencea and risk of bias assessmentb of Study population Eg N, age, gender, disease description and severity, baseline function Description of Intervention <including duration of treatment> Description of Comparator <including duration of treatment> Relevant outcomes assessed (ie related to outcomes specified in PICO) Measurement of outcomes and methods of analysis - - -