New Framework Sets National Value Threshold for Heart Drugs and Devices, Aiming to Balance Innovation and Access
Two major cardiovascular journals, JACC and Circulation, published a pair of companion papers introducing a new, practical framework for evaluating the economic value of cardiovascular drugs, devices, and preventive strategies. The writing group, chaired by Dhruv S. Kazi, MD, MSc, MS of Beth Israel Deaconess Medical Center and Harvard Medical School, recommends a single, evidence-based threshold of $120,000 per quality-adjusted life year (QALY) as a benchmark for determining whether new therapies deliver good value.
The new framework arrives at a time when the U.S. healthcare system faces rising costs, an aging population, and surging rates of diabetes and cardiovascular disease. Left unchecked, these trends threaten to outpace available resources. “This isn’t about spending less—it’s about spending smartly,” said Dr. Kazi, who is also the Associate Director of and Section Head of Health Economics at the Richard A. and Susan F. Smith Center for Outcomes Research. “Whether you believe our system must rein in runaway costs or that high spending fuels global innovation, you still need a consistent way to judge which therapies deserve investment. Our framework provides that clarity.”
Why it matters
U.S. health spending now exceeds $4.5 trillion annually, yet access remains uneven and medical debt widespread. The framework offers a transparent way to assess new interventions, asking a simple question: how much health do we get for each dollar spent? If a therapy delivers a year of good-quality life for less than $120,000, it generally represents a sound investment. If it costs more, it may still have merit but should be scrutinized more closely.
What’s new in the papers
- Unified threshold: Replaces the patchwork of legacy values ($50,000–$150,000/QALY) with a single, empirically supported benchmark.
- Guidance for special cases: Provides practical methods to assess high-cost rare-disease drugs, gene therapies, and cardiovascular devices.
- Equity lens: Argues that efficient use of healthcare resources typically advances population health and equity, rather than putting them in conflict.
- De-implementation signal: Calls on health systems not only to adopt high-value care but also to retire low-value interventions that drive up costs without improving outcomes.
The bigger picture
Dr. Kazi notes that two competing worldviews shape U.S. policy: one prioritizes controlling costs to improve access, while the other values sustaining high spending to support innovation. “Both perspectives ultimately demand the same thing,” he explained. “A systematic, evidence-based way to separate high-value innovations from low-value ones.”
The updated methodology is intended for guideline writers, policymakers, insurers, clinicians, and researchers. It also serves as a roadmap for the next generation of trainees in health economics, a field where fewer than ten experts nationwide currently focus on cardiovascular applications.
With cardiovascular disease still the leading cause of death and costs rising steeply, the framework offers a tool to ensure that limited dollars are directed to treatments that deliver the greatest benefit for patients and society.
About QALY: A QALY combines length and quality of life into a single measure. Spending less than $120,000 per QALY gained typically signals good value.
