Unintended Financial Barriers: When "Generic" Does Not Mean Affordable.

摘要

Sacubitril/valsartan is a foundational component of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF), demonstrating reductions in cardiovascular mortality and hospitalization in PARADIGM-HF. The introduction of generic sacubitril/valsartan was expected to improve affordability and expand access. However, real-world experience suggests that financial and administrative barriers persist despite generic availability. High deductibles under Medicare Part D, variable formulary placement, loss of manufacturer copay assistance, prior authorization requirements, and digital enrollment barriers continue to disrupt therapy continuity. These obstacles disproportionately affect elderly and socioeconomically vulnerable patients and contribute to cost-related nonadherence, treatment interruption and 'financial toxicity': the negative effects of the economic burden of medical care on patients. From a frontline clinical perspective, financial toxicity functions as a modifiable risk factor in HFrEF management. Aligning benefit design with evidence-based care is necessary to ensure that generic availability translates into sustained access and clinical benefit.