1. What is the question being asked in the report ?
   What type of economic analysis was performed to answer the question ?
   1. Cost comparison
   2. Cost-consequence analysis
   3. Cost-effectiveness analysis
   4. Cost-utility analysis
   5. Cost-benefit analysis

   What is the justification for the approach taken ?

2. Did the study involve a comparison of alternative treatments for patients with the same clinical condition ?
   Are those alternatives explicitly stated ?
   Is the analysis therefore an incremental analysis ?
3. Is the viewpoint or perspective for the analysis stated clearly ?
   Is it a societal perspective, third-party payer perspective, patient perspective ?
   Is the analysis presented in a disaggregated fashion showing these perspectives separately ?
4. Was the evidence of the product's efficacy established through randomized trials ?
   Was this evidence of efficacy supplemented by evidence of effectiveness applicable to the patients covered by the Ontario Drug Benefit Program ?
   Was the latter evidence derived from studies documenting routine use in clinical practice ?
5. Are the methods and analysis displayed in a clear and transparent manner ?
   Are the components of the numerator (cost of each alternative) and denominator (clinical outcomes of each alternative) displayed ?
   Are clinical outcomes expressed first in natural units and then translated into alternate units such as benefits or utility ? (See "Summary and suggested format").
6. Are all important and relevant costs and consequences (outcomes), including adverse effects, for each alternative identified ?
7. Are costs and consequences modelled as in a decision tree with information derived from a variety of sources or estimated directly from a specific patient population ?
8. Are capital costs and overhead costs included as well as operating costs ?
   How were they measured ?
9. How were indirect costs identified and estimated ?
10. How was quality of life measured ?
11. What equity assumptions were made in the analysis ?
    For example, are QALYs gained by any individual considered equal ?
12. If some variables were difficult to measure, how did the authors handle this difficulty ?
    Did they slant the analysis all in favour of one intervention in order to bias the analysis against the desired result ?
13. Were extensive sensitivity analyses performed ?
    What were the ranges of values for variables in the sensitivity analyses ?
14. Is quality of life an important component of an economic analysis of this question ?
    How sensitive is the estimate of cost utility to variations in quality of life ?
15. Is there an estimate of the aggregate incremental expenditure required for the province to provide this product to patients covered by its programs ?
    What is the estimate of aggregate incremental costs ?
    Does this estimate cover all of the major indications for use of the product ?
16. Has the incremental cost-effectiveness ratio been estimated for a specific clinical indication that represents the majority or all of its expected use by those covered under the Ontario Drug Benefit Program ?
    Do these other indications involve a large amount of utilization for which the ratio may be very different ?
17. Who performed the analysis ?
    Did the authors of the report sign a letter indicating their agreement with the entire document presented ?
    Does the report indicate that the authors had independent control over the methods and right to publish the analysis regardless of its results ?
18. What is the "bottom line" result of the analysis in quantitative terms ?
    The answer to this question will be statements like the following :
1. The cost per QALYs gained for using this product compared to the alternative is $X or ranges from $Y to $Z;
2. The use of this product compared to the stated alternative will result in an expected incremental expenditure of $X per patient treated with a net reduction of Y major adverse clinical events (e.g., cardiac deaths) and Z minor clinical events (e.g. side-effects).

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