Cost and Value in Contemporary Heart Failure Clinical Guidance Documents

John W. Ostrominski, MD; Sameer Hirji, MD, MPH; Ankeet S. Bhatt, MD, MBA; Javed Butler, MD, MPH, MBA; Mona Fiuzat, PHARMD; Gregg C. Fonarow, MD; Paul A. Heidenreich, MD, MS; James L. Januzzi, JR, MD; Carolyn S.P. Lam, MBBS, PHD; Thomas M. Maddox, MD, MS; Christopher M. O'Connor, MD; Muthiah Vaduganathan, MD, MPH

Disclosures

JACC Heart Fail. 2022;10(1):1-11. 

In This Article

Methods

Document Selection

CGDs published between January 2010 and February 2021, with a principal focus on heart failure (HF), were identified by searching content put forth by several major cardiovascular organizations: the American College of Cardiology (ACC), American Heart Association (AHA), Heart Failure Society of America, and European Society of Cardiology. Clinical practice guidelines, expert consensus documents, and appropriate use criteria were included in the analysis. Position statements and performance measures were excluded. Document sections not devoted strictly to the diagnosis or management of HF or that were focused on specific entities within the scope of HF (eg, myocarditis) were excluded from the analysis. Otherwise, sections dedicated to acute and chronic HF, regardless of stage, New York Heart Association functional class, or left ventricular ejection fraction, were included.

Analysis of Document Methodology, Cost and Value Sections, and Price Transparency

If reported, document methodology sections were reviewed for the inclusion of cost/value. If present, these cost/value considerations were classified according to a protocol adapted from a previous study.[11] Briefly, cost/value considerations in methodology sections were classified as follows: 1) explicit (a statement that cost or value was considered in the CGD development); 2) implicit (including a statement that costs could be considered only in selected instances); 3) excluded (a statement that cost/value was omitted during development); and 4) unmentioned. Each document was also reviewed for the presence of sections specifically devoted to cost/value. To evaluate for price transparency, documents were reviewed for the presence of estimated out-of-pocket costs for HF-related device- or drug-based interventions.

Abstraction and Classification of Cost and Value Statements and Citations

Cost/value statements, liberally defined as any instance in which cost or value was mentioned, were abstracted from each document by a single author (J.W.O). Each statement was subclassified by 2 authors (J.W.O and S.H.) on the basis of how it was used: 1) to highlight the economic impact of HF or HF-related interventions; 2) to advocate for cost/value-related issues; 3) to highlight cost/value as a gap in evidence; and 4) to justify specific clinical recommendations (Central Illustration). There was strong inter-rater reliability with respect to statement categorization (κ statistic = 0.80). Statements in category 4 were further subclassified according to whether they focused on management of societal costs vs patient-level costs. Statements in category 4 were also subclassified by whether the cost/value statement was used to support use or discourage use of an intervention, the rationale for use or nonuse, and whether supporting evidence was provided. The rationale provided for use or nonuse was adjudicated in a manner similar to that of a previous study.[11] Briefly, categories included the following: 1) recommending use given equal effectiveness at lower cost in routine cases; 2) recommending use because the incremental benefit justified additional cost; 3) recommending use to reduce future costs; 4) discouraging use because the cost-to-benefit ratio was uncertain; and 5) discouraging use because incremental benefit did not justify additional cost. Discrepancies were resolved by consensus with consultation of a third investigator (M.V.).

Central Illustration.

Cost/Value Statement Classification Schema
Cost/value statements (n = 179) were identified in 33 contemporary heart failure (HF) clinical guidance documents (published between January 2010 and February 2021) and classified according to how they were used in each document. Nearly 2 of every 3 cost/value statements were used to highlight the economic impact of heart failure and its related care, whereas less than one-fourth of these statements were used to support clinical guidance recommendations.

The citations accompanying each cost/value statement, if applicable, were also reviewed and categorized as cost-effectiveness/utility analyses or other (descriptive) analyses in the same fashion. All references sections were also reviewed to identify additional cost/value-related citations. To establish whether more recent documents exhibited different patterns of inclusion of cost/value content, the frequency of inclusion of cost/value statements and citations was compared between documents published in 2010–2015 and those published in 2016–2021.

Statistical Analysis

Frequency of inclusion of cost/value sections, citations, and statements was expressed as a percentage of all documents. Subtypes of cost/value statements were expressed as a percentage of all statements. Comparisons of continuous outcomes were performed using Wilcoxon rank-sum testing. Statistical analyses were performed using STATA software version 16.1 (StataCorp LLC). No patient-level data were accessed to require ethical approval or review by the Brigham and Women's Hospital Institutional Review Board.

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