|1. An economic evaluation should be communicated clearly and transparently to enable the decision maker(s) to interpret the methods and results
||· The decision problem must be fully and accurately described · Limitations of the economic evaluation in informing policy should be characterized · Declarations of interest should be reported
|2. The comparator(s) against which costs and effects are measured should accurately reflect the decision problem.
||At a minimum, the following comparative analysis should be undertaken: · The intervention(s) currently offered to the population as defined in the decision problem as the base case comparator · A “do nothing” analysis representing best supportive (non-interventional care) for the population as additional analysis
||Clear description of comparator(s) that includes: · Basic descriptive information including setting where comparator is administered · Statement of availability of the comparator across the population being considered Differences between mean costs and effects of the intervention and chosen comparators should be reported as incremental cost effectiveness ratios
|3. An economic evaluation should considerall available evidence relevant to the decision problem.
||· Apply a systematic and transparent approach to obtaining evidence and to judgments about evidence exclusion · Estimates of clinical effect of intervention and comparator(s) should be informed systematic review of the literature · Single-study or trial-based analyses should outline how these are an adequate source of evidence and should ensure that the stated decision problem is specific to particular context and time of the study or trial · Budget and time allocated to perform an economic evaluation should not determine selection of evidence.
||Describe approach used to obtain included evidence · Systematic review protocol and evidence search strategies should be made available · List sources of all parameters used in economic evaluation · Describe areas where evidence is incomplete or lacking
|4. The measure of health outcome should be appropriate to the decision problem, should capture positive and negative effects on length and quality of life, and should be generalisable across disease states.
||· Disability-Adjusted Life Years (DALYs) averted should be used. · Other generic measures that capture length and quality of life (eg QALYs) can be used in separate analysis where information is available
||Clear description of method of weighting used to inform the DALY plus · Discussion of any important outcomes insufficiently captured by the DALY · If DALYs not used, provide justification with description of impact of alternative measure.
|5. All differences between the intervention and the comparator in the expected resource use and costsof delivery to the target population(s) should be incorporated into the evaluation.
||· Estimates should reflect the resource use and unit costs/prices that may be expected if the intervention is rolled out to the population defined in the decision problem · Costs not incurred in study settings but likely if intervention is rolled out should be captured in the base case analysis · Cost all resource implications relevant to the decision problem, including donated inputs and out of pocket inputs from individuals · Analysis should include estimation of changes in costs estimates due to scalability
||· Quantities of resources should be reported separately from their unit costs/prices · Capital and fixed costs should be annuitized over the period of implementation · Description of how the costs have been validated (eg corroboration with similar interventions in similar settings) · Any major differences between predicted (modeled) and realized costs should be explained · Implications of changes in costs due to scalability of the intervention should be reported · Costs should be reported in local currency and in United States dollars. · Costs should be converted to US$ and local currency; date and source of exchange rates should be reported.
|6. The time horizon used in an economic evaluation should be of sufficient length to capture all costs and effects relevant to the decision problem; an appropriate discount rate should be used to discount cost and effects to present values.
||Lifetime time horizon should be used in first instance. · A shorter time horizon may be used where shown that all relevant costs and effects are captured. · 3% annual discount rate for costs and effects in base case, with additional analyses exploring differing discount rates · Additional analysis should explore an annual discount rate that reflects the rate for government borrowings · Where the time horizon is> 30 years, the impact of lower discount rates should be explored in a sensitivity analysis
||State the time horizon over which costs and effects have been evaluated, including additional analyses if different time horizons have been explored. · If lifetime time horizon is not used, justify why and report impact of different time horizon(s) · State the discount rate used for costs and effects, and include additional analyses using different discount rates. · If a 3% annual discount rate is not used, justify why and report impact of different discount rate(s)
|7. Non-health effects and costs associated with gaining or providing access to health interventions that don’t accrue to the health budget should be identified where relevant to the decision problem. All costs and effects should be disaggregated, either by sector of the economy or by whom they are incurred.
||· Base case analysis should reflect direct health costs and health outcomes; however the analysis should adopt a disaggregated societal perspective · Non-health effects and costs that fall outside the health budget should be included in additional analysis; the mechanism of inclusion will differ depending on the decision problem and context. · Where external funding or individual OOP payments substitute for costs that would otherwise fall on a health budget, these costs should be included in the base case analysis, however the impact of excluding these should be explored in sensitivity analyses
||Clear description of the result of the base case analysis, plus · Alternative analyses exploring impact of individual out of pocket payments and external funding should be explored · Non-health effects and costs that fall outside the health sector should be reported and the mechanisms used to report impact of these cost and effects should be explained and justified · If non-health effects and costs that fall outside the health sector are not included, the reasons should be reported and estimations of the potential impact of these exclusions made
|8. The cost andeffectsof the intervention onsub-populations within the decision problem should beexplored and the implications appropriately characterized.
||Heterogeneity should be explored in population subgroups, where subgroup formation should be informed by: · Relevant effect of the intervention differs in different populations · Characteristics of different populations that may influence the absolute health effects · Characteristics that influence direct costs of provision or other associated costs across the constituency Subgroup analysis should always be determined by: · The evidence base regarding differences in relative effect, baseline risk or other characteristics · Whether the differences are likely to have an important influences on costs and effects
||Clear reporting of: · subgroup characteristics, and justification of why particular groups are chosen for subgroup analysis · evidence base used to determine subgroup specification · the cost effectiveness of the intervention in the different subgroups · subgroups with potentially important differences in costs and effects but excluded due to lack of evidence
|9. The uncertainty associated with an economic evaluation should be appropriately characterized.
||The economic evaluation should explore: · Uncertainty in the structure of the analysis · Uncertainty due to source of parameters · Uncertainty due to precision of parameters
||The effects of all types of uncertainty should be clearly reported, noting impact on final results. · Uncertainty due to parameter precision should be characterized using sensitivity analyses appropriate to the decision problem. · The likelihood of making the wrong decisions given the existing evidence should be addressed
|10. The impact of implementing the intervention on health budget and on other constraints should be clearly and separately identified.
||· Budget impact analysis should estimate the implications of implementing the intervention on various budgets · Budget impact analysis should reflect the decision problem and the constituency in which the intervention will be used.
||Disaggregated and annualized budget impact analysis should be reported that shows budget implications for:
- Government and social insurance budgets
- Third-party payers
- Households and out of pocket expenses
- External donors
|11. An economic evaluation should explore the equity implications of implementing the intervention.
||There are various mechanisms available for assessing equity implications of an intervention. · The method chosen should be appropriate to the decision problem and justifiable to the decision maker · Equity implications should be considered at all stages of the evaluation, including design, analysis and reporting
||The method used to incorporate equity implications should be clearly and transparently explained. · A minimum level of reporting should include a description of particular groups within the constituency that may be disproportionately positively or negatively affected by a decision to implement (or not implement) the intervention.