OBJECTIVES : Based on the results of the AHeFT study, fixed-dose combination (FDC) isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD) reduced all-cause mortality in self-identified as black with heart failure (HF). This study aims to estimate the potential budget impact of increasing the proportion of FDC-ISDN/HYD use in the Medicare population over two years.

METHODS : A budget impact model was developed with inputs from the literature to estimate, the impact of a 5% increase/year in the proportion of patients using FDC-ISDN/HYD due to a switch from off-label combinations of the separate generic drugs ISDN and HYD (OLC-ISDN+HYD) therapy, using a hypothetical health plan of one-million members. The target population was HF Medicare beneficiaries prescribed FDC-ISDN/HYD or OLC-ISDN+HYD over a two-year time horizon. The eligible population for FDC-ISDN/HYD was based on the treatment guidelines. Medication cost was estimated from the 2019 Average Wholesale Prices obtained from the Red Book for FDC-ISDN/HYD and OLC-ISDN+HYD. FDC-ISDN/HYD prescribing trends were obtained from a 2005 to 2011 retrospective database analysis. One-year survival advantage for FDC-ISDN/HYD was 87.9% compared to 83% for OLC-ISDN+HYD. Annual direct medical cost was adjusted by the potential increase in medical cost due to increased survival from the FDC-ISDN/HYD population. The primary outcome of interest was the net cost per-member-per month (PMPM).

RESULTS : Estimated current market share of FDC-ISDN/HYD was 2.4% compared to 16.6% of OLC-ISDN+HYD. The annual cost of treatment was $6,685.89 for FDC-ISDN/HYD and $2,852.86 for OLC-ISDN+HYD. Cost of HF-related hospitalization was estimated at $14,631 per-patient. PMPM increased by $0.07/year mainly due to increased medication cost ($765,323.64) and increased medical cost due to increased survival ($78,451.05).

CONCLUSIONS : FDC-ISDN/HYD has been shown to increase survival. The increase in the accompanying medical cost and medication cost from the switch increases PMPM by $0.07/year, indicating that switching to FDC-ISDN/HYD may be clinically beneficial with minimal economic impact.