SummaryOn March 27, the American College of Cardiology (ACC)/ American Heart Association (AHA) announced that they will begin to include cost and value information in their guidelines recommendations, while simultaneously publishing a methodology statement on how guideline writing committees should incorporate this information.
While professional societies have been encouraged to consider cost in their evidence assessments by the Institute of Medicine and the Council for Medical Specialty Societies, this approach has not yet been standardized in the guideline development process. In many cases, the evidence for cost or cost-effectiveness for clinical treatments are not yet widely available, which is why consideration of cost or value varies considerably among guideline documents. Most professional societies still refrain from making cost an explicit consideration for their recommendations, but do acknowledge applicable and available cost issues or considerations in their evidence reviews.
As part of this methodology, ACC/AHA would assign a “level of value” (LOV) to guideline recommendations, designating whether a given treatment is of “high, “intermediate,” “low” or “uncertain value.” The societies recommend using all initial and subsequent costs of a given therapy and the ”quality-adjusted life year” as an outcome measure. To assign a LOV using cost-effectiveness, the threshold of $150,000 per quality-adjusted life year (QALY) will be used and treatments above that threshold considered low value.
Given that clinical practice guidelines are widely cited and used in a variety of ways including clinical decision making, coverage decisions, quality measure development, this development could have wide-ranging implications if this represents a broader trend in guideline development. The life sciences industry will likely need to generate high-quality economic data in clinical trials in order to differentiate the value and cost effectiveness of their products from alternatives. Also given ongoing efforts to redistribute financial risk in healthcare, industry will also consider the use of real-world data to quantify how their products affect resource use from not only a societal perspective but also the patient and provider perspective.
Payers and other “accountable” entities will have more information to guide decisions around coverage and payment for healthcare treatment and services. Since there is a relative lack of economic data on many treatments and additional resources are needed to incorporate cost and value information, it is unlikely that these new guidelines will be available in the near term. When applied, these guideline changes are likely to focus on the few high cost and/or high volume treatments and procedures with sufficient high-quality economic data.
It is still unknown how professional societies will adjust their document development processes to include cost and value considerations in guideline recommendations. If implemented, however, it would extend already lengthy development timelines and bring greater scrutiny for recommended treatments from the medical community. Determining the best approach is still a work in progress but this initial announcement is a first step.
View the ACC/AHA press release.