Future ACC/AHA Guidelines to Incorporate Cost/Value Considerations

For 30 years, the ACC and AHA have been developing consensus guidelines intended to inform medical practice, using methodologies that have been adopted by virtually all other major medical specialty societies. In many ways, cardiovascular medicine has provided leadership in generating, synthesizing, evaluating, and interpreting clinical evidence on which to base clinical decision-making. To a large extent, these guideline documents have come to define evidence-based standards of care in our specialty.

Until now, ACC/AHA guideline committees have not explicitly considered issues related to cost, cost-effectiveness, or “value” when developing their documents. With the publication of a new ACA/AHA committee statement,1 however, it appears that the long-standing practice of not directly addressing cost issues in guideline documents will soon change.

The cost methodology statement was written by a committee of cardiologists and experts in health economics research, under the auspices of ACC/AHA Task Forces on Performance Measures and Practice Guidelines. In addition to providing general background on the rationale and challenges involved in considering health economics in guideline statements as well as background on basic health economic research methods, the document makes several concrete recommendations on how to begin implementing assessments of cost or value into the guidelines process.

Among the important recommendations are the following.

• The committee has quite deliberately emphasized the terms “value,” and secondarily “resource utilization” over “cost” or “cost-effective.”
• The committee suggests that assessments of value be added to, and not alter, the traditional class of recommendation/level of evidence (COR/LOE) approach to rating clinical safety and effectiveness.
• Based on criteria published by the World Health Organization (WHO),2 the upper limits of what may be considered widely acceptable from a cost-effectiveness perspective is a cost per quality adjusted life year (QALY) gained of 3 times the per capita gross domestic product (GDP) of a country. In the US, this translates to an approximate threshold of $150,000 per QALY gained.
• Proposed categories for “level of value” (LOV) include high value: improved clinical outcomes at reduced cost, or an incremental cost-effectiveness ratio of <$50,000 per QALY gained; intermediate value: $50,000 to $150,000 per QALY gained; and low value: ≥$150,000 per QALY gained (or worse clinical outcomes at higher cost). Since good quality evidence may be lacking in many cases, the committee also proposed categories of “uncertain value” (when data are conflicting or of poor quality) and value “not assessed.”
• The committee recommended development of a standard, systematic approach to evaluating published health economic studies, so that the health economic evidence can be graded in a manner analogous to the current grading of clinical evidence.
• The committee recommended that clinical Class I interventions deemed as having low value not be considered for national performance measures.

The writing committee has tackled a thorny issue in health care, and done a thorough and commendable job of discussing the major issues. There is currently no question that US healthcare spending has for many years been on an unsustainable trajectory. All stakeholders, including physicians, need to be involved in improving the value of medical care.

That said, the incorporation of value assessments into practice guidelines will not be simple or without controversy. First, many common clinical strategies lack good quality evidence regarding value. Even when good quality evidence is available, however, it is not clear how, or even if, it should be used in clinical care. Practice guidelines have always aspired to assist clinical decision-making at the individual patient level. Health economics research, on the other hand, generally aims to inform policy making at a much broader (health system or societal) level. While the writing committee attempted to describe some scenarios of how value assessments might be used, they emphasized that “the goal of incorporating considerations of value into guideline recommendations should be to provide information rather than to be prescriptive.”

This overriding position of not being “prescriptive” is practical, but raises questions about how impactful this entire exercise may be, at least in the short term. One point made by the authors that bears repeating here, is that consensus guidelines to a certain extent have always implicitly addressed the concept of value by identifying and expressly discouraging clinical practices known to be ineffective, i.e. Class III recommendations. Ineffective care always has poor value. The authors also rightly point out that endorsing certain clinically effective practices as high value could help “guard against the unintended consequences of capitation-based reimbursement.”

If the clinical response to high value interventions is straightforward, what then should happen for interventions of intermediate or low value? It is here where physicians’ dual obligations to advocate for their patients while simultaneously acting as responsible stewards of societal resources may conflict. The committee suggested that value assessments could potentially be used as a sort of “tie-breaker” in cases where the clinical evidence is equivocal. The committee stops short, however, of declaring that low value interventions should never be adopted, acknowledging that in “exceptional cases, a resource-intensive therapy may provide the only effective/life-saving treatment available” and thus may “be considered by society as appropriate.” It would seem then, that clinical considerations could still trump value considerations in some unusual cases where clinical evidence and value evidence point in different directions.

It will be interesting to see how other players in the system, in particular government and private insurers, respond to the incorporation of value evidence into ACC/AHA guideline statements. Unintended consequences are always possible, and should be guarded against. Whatever those reactions may be, it is the committee’s stance that value issues in cardiovascular medicine are sufficiently important that they deserve detailed scrutiny in the guideline development process, and frank discussion in guideline documents – and beyond.