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 trial - 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 consideration” in “other 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.
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
MSAC%20Assessment%20Report%20Critique%20Template%20-%20Therapeutic.docx