BOCA RATON, FLA. — The cost of fixed-dose isosorbide dinitrate and hydralazine is more than offset by decreases in health care resource utilization by African Americans with moderate to severe heart failure, according to a poster presented at the annual meeting of the Heart Failure Society of America.
Primary end points of the African Americans Heart Failure Trial (A-HeFT) were death, first hospitalization for heart failure, and change in quality of life (N. Engl. J. Med. 2004;351:2049–57).
In addition, the researchers collected enough data to assess the economic impact of the drug combination and other factors during the trial.
“We looked at all resource utilization,” Walter T. Linde-Zwirble said in an interview. “There is, nowadays, an economic story, not just a clinical story,” with new medications.
“A therapy has to decrease the cost of care or provide enough of a definable outcome at an acceptable price,” said Mr. Linde-Zwirble, a consultant hired by Nitromed Inc., the makers of fixed-dose isosorbide dinitrate and hydralazine (BiDil).
“Knowing it's a study sponsored by industry, I took every possible bias against the drug into account,” explained Mr. Linde-Zwirble, who is vice president and chief science officer at ZD Associates in Perkasie, Pa.
The researchers calculated hospital costs according to length of stay, gender, and hospital survival by using 2003 Medicare data adjusted to 2004 dollars. They estimated background care, such as unscheduled physician and emergency department visits, by using average payments for a 5% sample of patients in the Medicare Part B database.
Medication costs were estimated by using average wholesale prices from the 2004 Red Book. The cost of fixed-dose isosorbide dinitrate and hydralazine included the manufacturer's announced price of $1.80 per tablet, the average prescribed dose, and compliance data from the A-HeFT.
“The only things that made a big difference were the costs of hospitalizations and the cost of BiDil,” Mr. Linde-Zwirble said. Treatment was associated with a smaller number of hospitalizations and shorter hospital stays.
The heart failure costs—including the cost of the drug combination—were 6% lower in the treatment group, compared with the placebo group.
“The drug provided a $533 cost savings with 23 additional days of survival, an astounding increase in survival,” Mr. Linde-Zwirble said.
“The more you use the intervention on appropriate patients, the more money you will save,” Mr. Linde-Zwirble said. “Cardiologists 5 years from now will have a good idea of how BiDil fits in—it's still new.”