BiDil® COST EFFECTIVENESS

Despite advances in care, heart failure remains a major health concern, shortening survival, impacting quality of life and requiring frequent hospitalizations.  There is a major cost burden in treating heart failure in the United States; approximately five million Americans currently have heart failure, with 550,000 new cases diagnosed each year.  Costs to treat the disease are staggering and are estimated at $28 billion in 2005. This figure includes inpatient care – with associated physician and professional fees, laboratory charges and pharmacy costs – plus outpatient care. 

Not only are blacks 50% more likely to develop heart failure compared with white Americans, but according to the National Heart, Lung, and Blood Institute, blacks tend to develop heart failure at an earlier age than  other Americans. Their symptoms also tend to be more severe and to worsen more quickly, resulting in earlier disability, and higher rates of both hospitalization and premature death.  Thus, there is not only a disproportionate physical burden on black heart failure patients, but also a substantial economic burden.

According to a pharmacoeconomic analysis titled “Cost-Effectiveness of Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine Therapy for Blacks with Heart Failure” published in the  December 13, 2005 issue of Circulation: Journal of the American Heart Association, BiDil® (isosorbide dinitrate/hydralazine hydrochloride) is a cost-effective way to treat heart failure in self-identified black patients.  Study results indicate that treatment with BiDil in the African American Heart Failure Trial (A-HeFT) reduced heart failure-related and total healthcare resource use and costs, due primarily to substantial reductions in both number and length of heart failure-related hospitalizations. 

Hospitalization information was collected during monthly phone interviews and study visits, including a review of medical records to determine the reason for hospital admission.  The reason for hospitalization was independently and blindly adjudicated as heart failure related or not.  A Medicare-based cost-estimate system was established to determine hospitalization and length of stay costs.  The retail cost per BiDil tablet and the average prescribed dose in A-HeFT was used to account for the treatment cost. 

Including the retail cost of BiDil at the time of the pharmacoeconomic analysis, use of BiDil versus placebo in A-HeFT during the follow-up period resulted in per patient savings of $533 for heart failure-related costs and savings of $1,730 for total direct healthcare costs. 

Data gathered during A-HeFT indicate the following for patients taking BiDil:

• 30 percent reduction in heart failure-related hospitalizations
• 41 percent reduction in the length of hospital stay
• 6 percent decrease in heart failure-related costs (including the cost of BiDil)
• 9 percent decrease in total healthcare costs (including the cost of BiDil)

While the pharmacoeconomic analysis indicates BiDil’s cost-savings during the trial period (A-HeFT followed patients for an average of 12.8 months), the economic model also suggests long-term use of BiDil will be cost-effective.

Assuming no additional benefits accrue beyond the trial, the study projects the cost-effectiveness of BiDil using heart failure-related costs to be $16,600 per life-year at two years post enrollment, $37,100 per life-year at five years, and $41,800 per life-year over lifetime, suggesting that BiDil would remain cost-effective over the long-term. 

Long-term costs per years of life saved were generated based on lifetime estimates of costs and effects as per the U.S. Public Health Service Panel on Cost-Effectiveness in Health and Medicine (PCEHM), with costs expressed in 2004 costs and increasing at a rate of three percent each year.