ACC and AHA outline calculation of cost-effectiveness in clinical practice guidelines
Healthcare has increasingly become much more cost-conscious over the past 20 years. Return on investment (ROI) evaluations are now needed before health systems or cardiology departments institute new technologies, procedures, or clinical practices. This cost-conscious environment prompted the American College of Cardiology (ACC) and the American Heart Association (AHA) to develop a statement on cost/value methodology when creating clinical practice guidelines in 2014, and this week they released an updated version.[1]
Over the past decade since its first publication, the statement has served as a methodological guidepost for economic evaluations in cardiology and has led to the routine incorporation of value statements in ACC/AHA guidelines. There also have been many articles focused on cost-effectiveness analysis (CEA) and important advances in CEA methodology in healthcare. This includes the introduction of novel alternatives to quality-adjusted life years (QALYs), as well as an increasing emphasis on patient-centered and patient-reported outcomes.
However, the authors of the new statement said there are remaining challenges in CEA methodology, including a lack of clarity on nationally representative costs for new drugs and devices, interpretation of heterogeneity of cost-effectiveness across subpopulations, and problems in addressing health inequities—all of which the AHA and ACC attempted to address in the new statement.
"This ACC/AHA methodology statement provides updated guidance for investigators, academic journals, and clinical guideline committees regarding the rigorous evaluation of CEAs. This update incorporates novel CEA methods and highlights areas where further methodological research is needed. It updates the cost-effectiveness thresholds to reflect currently available empiric evidence regarding willingness-to-pay thresholds in the United States. Importantly, the 2025 update includes a focus on health equity in CEA, with the goal of ensuring that decision-makers employ high-quality evidence in efforts to improve population health," wrote the authors from the ACC/AHA Joint Committee on Clinical Practice Guidelines in the document introduction.
Scrutiny of the cost and value of healthcare interventions
The committee noted that over the past 20 years, new strategies for preventing and treating cardiovascular disease have substantially improved population health outcomes in the United States. At the same time, however, uneven access and rising healthcare costs have led to increased scrutiny of the cost and value of new interventions. They emphasized that this context is important when developing care guidelines, especially since the cost of treating cardiovascular disease in the U.S. is projected to quadruple over the next 30 years. Such growth could force difficult decisions in the future, making cost analysis in guidelines increasingly critical.
"Because societal resources are finite, resources used to deliver one type of health intervention, like a novel treatment for heart failure, are then no longer available to provide other healthcare interventions, such as screening for hypertension. Optimal allocation of societal resources creates a need to understand tradeoffs between alternative uses of available resources, because committing resources to a particular option generates the “opportunity cost” of foregone benefits that would have accrued if the resources had instead been committed to an alternative," the authors wrote.
For this reason, they said CEAs can help promote efficient allocation of finite societal resources by weighing the effectiveness of an intervention against the incremental use of resources. CEAs are not just about minimizing costs, but also a way to systematically evaluate the incremental cost-effectiveness of an intervention relative to the next-best alternative to maximize population health benefits. This type of cost-benefit information can help inform decision-making at the policy and health-system level.
"The underlying objective of the costing exercise is to quantify the resources required to adopt the study intervention relative to the chosen comparator," according to the statement.
High-quality CEAs incorporate a comprehensive assessment of costs—including the initial cost of the intervention, the cost of delivering the intervention, and related expenses such as outpatient visits needed to adjust a therapy dose or manage adverse events. They should also account for future costs resulting from prolonged survival, as well as any savings from averted cardiovascular events.
The statement emphasizes that economic value statements in ACC/AHA guidelines should primarily rely on CEAs that use costs observed or estimated within the U.S. population.
Which therapies need a value statement and how is it calculated?
When feasible, the authors said guideline committees should consider including economic value statements for interventions that receive Class 1 and 2A recommendations in clinical guidelines, as well as interventions where understanding economic value is likely to influence adoption.
Two measures commonly used for cost-effectiveness are highlighted in the statement: incremental cost-effectiveness ratio (ICER) and the Criteria for Health Economic Quality Evaluation (CHEQUE).
CHEQUE is an established quality assessment tool designed to evaluate the methodological rigor of a health economic study. It examines key structural components of an analysis and defines how much the study deviates from a preferred reference case. However, the authors cautioned that expert judgment is still required.
ICER represents the difference in costs divided by the difference in effectiveness between two strategies. It helps show the additional cost required to gain one additional unit of effectiveness, typically measured as cost per quality-adjusted life year gained.
The statement also notes other measures to consider, including health outcomes, intervention costs, future costs, budget impact, and health equity.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]