Note: This analysis requires specialised expertise, so you may need outside help to conduct some or all of its components.

If a risk is deemed significant enough to be assessed, it calls for a budget impact analysis at a minimum. The risk management team can then decide whether a full economic assessment (budget impact and cost utility assessment) is needed. A full economic assessment requires specialized expertise and financial literacy. Depending on the complexity of the assessment, blood establishments may wish to hire a health economist to conduct the analysis.

• Core concepts: Applied economics rests on three core concepts:
  • Scarcity exists, and there are insufficient resources to support all possible activity; in other words, budgets are limited and not all interventions can be implemented.
  • A necessary consequence of scarcity is choice, which involves decisions between competing alternatives.
  • Making choices involves an opportunity cost; when resources are used for a specific purpose, they are not available for other purposes that may also have benefits.
• Guiding principles: The following principles can help guide the health economics and outcomes assessment.
  • Health economic analysis is not static: Decisions should be reviewed as better or more data becomes available.
  • Societal perspective: Donated blood is a societal good, so the societal perspective should always be considered. This perspective includes  the costs and impacts to all stakeholders. If an analysis uses a more limited perspective this must be justified.
  • Context: Economic thresholds for deciding on an intervention must be established in the context of blood transfusion risk. Preventing some risks is considered more important than preventing others.
  • – Transparency and best practices: Health economic analyses should be transparent and adhere to established best practices.
  • Estimation: When hard data are not available, other methods can be used to help in decision-making, such as estimates from recognised experts.
  • Proportionality and precaution: Health economic analyses support the notion of proportionality (balance between risks and benefits, overall increase in safety). In situations where uncertainty is very high, however, it may be appropriate to favour precaution over a proportional intervention.
  • Overall role: Health economics and outcomes assessments are only one consideration in the decision-making process; other assessments or priorities may carry greater weight. Opportunity cost should also be considered.

Step 1
Frame the question and select the perspective

Objective

Clearly state the health economic questions to be answered and determine the “lens” you will use to conduct the analysis.

Actions

• Formulate the evaluation question(s) by defining:
  • What is the problem?
  • Why is it important?
  • What do we need to know?
  • What is the focus of the evaluation?
  • The clarity of the question will have an impact on the approach and required resources.
• Select an analysis perspective, such as:
  • Societal
  • Health-care system
  • Local blood service operation(s)

• Identify stakeholders that need to be considered in the economic analysis using the stakeholder identification tool for guidance.
• Create an outline for the structure of the analysis, including the health economic impact of the threat on specific groups (blood services, donors, recipients, society, etc.).

Step 2
Select the health economic evaluation method

Objective

Decide which evaluation method is best suited to your situation.

The evaluation method will include a budget impact analysis (BIA) at minimum. Situations that are more complex call for cost utility analysis (CUA) as well.

Actions

• While both BIA and CUA are often necessary to support an informed decision, BIA may be sufficient in some situations.
• As far as possible, outcomes should be described with common metrics (e.g. QALY), otherwise it is nearly impossible to understand which interventions maximise population health.

Step 3
Conduct the analysis

Objective

Select and use the economic model appropriate to the analysis.

Actions

• Select an appropriate economic model for the assessment. Models are simplified representations of a range of possible outcomes. The choice will depend on the specific process or technology to be analysed, the nature of the hazard, and the evaluation method used (i.e., BIA and/or CUA).
• The best model for a given question should be no more complex than necessary to answer the questions. It is important to ensure transparency and to adhere to established best practice in modelling.
• Specify the structure of the model.
• Populate the model with data.
• Run the analysis, following established best practices.
• Obtain and interpret results.

Step 4
Assess uncertainty and sensitivity

Objective

Obtain insight into the likelihood, level of uncertainty, and sensitivity of outcomes.

Actions

• Determine the level of uncertainty in the threat.
• In most health economic models, uncertainty arises from scarcity or unreliability of data, rather than lack of understanding of cause and effect, in other words the outcomes are known, but not their magnitude or likelihood.
• When there are large uncertainties about the values to use in model parameters, both sensitivity and uncertainty analyses can help to contribute to the decision.
• Depending on the level of uncertainty, select the appropriate sensitivity analysis method(s):
  • A deterministic sensitivity analysis highlights the model parameters with the most influence on the assessment results.
  • A probabilistic sensitivity analysis estimates the overall uncertainty about various model outcomes and the contribution of baseline assumptions to the uncertainty.
  • In situations where uncertainty is very high, an intervention that favours precaution is advised.
  • As new information becomes available, the risk level and health economics of the earlier decision should be re-evaluated. (e.g. when variant Creutzfeldt-Jakob disease first emerged, extremely cautious interventions were adopted because of the lack of knowledge. Since then risk and heath economic analyses have not supported the adoptions of specific targeted interventions).

Note: Many situations call for both methods because they provide different types of information.

• Interpret the sensitivity analysis results and the observed relationships between model inputs and outputs.
• Prepare a brief summary of the results of the two sensitivity analyses, which you will incorporate into the final report.

Step 5
Manage data limitations

Objective

Identify ways to conduct the assessment when data are unreliable or unavailable.

Actions

• If empirical data to guide the health economic analysis are not available, decide on an alternative method to define input values:
  • Consensus method
  • Expert opinion
• The use of expert opinion for making predictions should be documented.

Step 6
Present and interpret results

Objective

Prepare a report that allows decision-makers to interpret results.

Actions

• Present BIA results for each risk management option (intervention) considered, both as separate costs incurred by specific groups and as total costs of implementing the intervention.
• Present CUA results, both as the separate costs and effects for each intervention and also as a ratio of costs to effects when comparing two or more interventions.
• Present CUA results graphically in a cost-effectiveness plane (see example below), in which:
  • Calculate the ICER for each risk management option compared to the status quo (doing nothing to mitigate the risk).

  TIP

  • Consider your region’s health economic thresholds. For example, US $50,000/QALY has significant traction as a cost-effectiveness threshold. Another example is a cost-effectiveness ratio of <3x gross domestic product per capita.
  • At the same time recognise that cost-effectiveness ratios for risk prevention are usually much higher because people and societies are often willing to pay more to avoid risks outside their control.

  Each risk management option will fall into one of these quadrants.¹ Uncertainty is displayed as confidence ellipses.

Determine whether a cost-effectiveness threshold is appropriate for interpreting the results.

Interpret the results.

Create a report with the results, interpretation, and rationale for the interpretation; clearly state the source of your data and/or assumptions in the report.

Step 7
Critique the analysis

Objective

Evaluate the quality, completeness, and robustness of the analysis.

Actions

• In most cases, the selected model cannot be formally validated because this would require gathering data after implementation of strategy. However, a peer review of the model could help establish validity.
• Checklists are useful tools for reviewing health economic studies.

• Enlist experts to review the analysis. Include:
  • Subject- matter experts who can judge the sensitivity of the outcomes.
  • Health economic experts who can judge the methodology.
• Ensure the reviews include:
  • An assessment of the use of data and other evidence
  • An assessment of the model and outcome face validity
  • An assessment of adherence to best practices
  • A verification of the sensitivity and uncertainty of model outcomes
  • A comparison of the assessment results to those of similar studies
• Have the experts use checklists to evaluate the quality of the work. Here is a sample checklist.
• If the reviewers uncover flaws in the analysis, communicate this to the analysts so they can make required changes.
• Update the HEO report as needed.

Note: Use independent experts to avoid biased critiques.

Step 8
Integrate findings into framework

Objective

Integrate the results of this analysis with the results of other assessments.

Actions

• Prepare a report summarising your findings

For an in-depth review of the health economics and outcomes assessments in the context of blood safety management, see article by Brian Custer and Mart Janssen available on https://riskframework.allianceofbloodoperators.org