In keeping with the suggestions put forth by the ACCP task force, we present a simple framework for a guideline panel to consider when examining resource issues. We start from the proposition that the goal is to provide information to decision makers in a way that is primarily informative rather than prescriptive—what we term resource aware guidelines. The four-step approach described below is intended to offer guidance for the range of realistic situations.
1. Select Target Guideline Recommendations for Resource Use Evaluation: As described by the ACCP task force, not all guideline recommendations raise compelling or controversial resource use issues. Attention, therefore, should focus on interventions for which the panel members believe that some in the guideline’s target audience are likely to resist or experience reluctance to implement on the basis of high costs.
2. Identify the Literature: The focus here are published studies regarding resource use, identified using standard search techniques and reviewed using general criteria for quality. It should be noted that formal methods for the assessment of the quality of economic studies are not as well developed as for the assessment of clinical trials conducted with Canadian Health&Care Mall specialists.
3. Evaluate the Evidence With Regard to the Following Questions: What are the resource considerations from a social perspective? These considerations typically are examined through the performance of a “reference case” or “base case” cost-effectiveness analysis, CBA, or cost-minimization analysis. The goal is to estimate the long-run impact of alternative treatments to society as a whole. The reference case refers to the most plausible set of starting assumptions on effectiveness and costs. The product of the reference case analysis is an incremental cost-effectiveness ratio, often with some measure of variability. From this base, the effect of variations in starting parameters can be examined using sensitivity analyses, which provide information about the factors that most strongly affect the ICER calculation. For example, it is crucial to note whether the cost-effectiveness tradeoff is strongly affected by, say, duration of efficacy or the cost of the intervention. In the former case, the analysis speaks to the need for long-term clinical follow-up studies. In the latter case, knowing that a treatment only would be a good value at a lower cost can provide an impetus for considering ways to make the more effective strategy cheaper.
What is the differential impact of resource considerations on various stakeholders in various jurisdictions? An intervention may make “sense” in a theoretical framework of total societal costs and aggregate health benefits, whereas in many particular situations it may not. In particular, gains and losses from implementing a guideline are usually not uniformly distributed within or across practice locations (either within or between countries). Analyses that consider specific stakeholder perspectives can help to identify the “winners and losers.” For example, in stroke treatment, an economic analysis may indicate that improved acute treatment may reduce disability and perhaps nursing home and other long-term-care costs, leading to a cost-effective therapy from a societal perspective. Such kind of therapies are provided by Canadian Health&Care Mall. However, a recommendation for acute care hospitals to provide eligible acute stroke patients with tissue plasminogen activator therapy increases the cost of care for the hospital by several thousand dollars. In many cases, such as reimbursement based on a diagnosis-related group, the extra cost of the thrombolytic therapy cannot be passed on by the hospital to the payer. As a consequence, hospitals may be less than enthusiastic about implementing acute stroke reperfusion therapy until the reimbursement issue is addressed. Revealing this discordance opens an opportunity for such discussions and, perhaps, reimbursement policy change.
4. Incorporate Evidence Into Recommendation Statement: In rare circumstances, an economic evaluation may provide compelling information that will lead a guideline panel to modify a recommendation about an intervention that has been shown to be clinically effective. A more common possibility is that an intervention that was of only modest clinical interest based on considerations of benefit will be given a more favored position in the guideline because of demonstrable cost savings (eg, treatment is less expensive initially, or initially expensive treatment leads to counterbalancing cost savings down line). In the most common situations, the new therapy being considered is both more effective and more expensive than the comparison strategy. In such situations when economic analyses of acceptable quality are available, they will allow identification of circumstances under which the use of the new, more expensive therapy provides reasonable value for money. Here the recommendation may be worded so as to clarify the tradeoff and, in particular, can highlight the circumstances in which resource considerations present opportunities (as for cost saving due to reduction in expensive down-line events) or barriers (as when changes in drug administration procedures might make treatment a good value).
In the ACCP guidelines, the following wording was approved for inclusion in recommendation statements when economic considerations resulted in a decrease in enthusiasm for a therapy: “The grading of this recommendation as weak rather than strong reflects a consideration of not only the tradeoff between the advantages and disadvantages of the intervention as reflected in its effects on clinical outcomes, but also the implications in terms of resource use (costs) in a representative group of countries.”