‘Lackluster’ Sales of First FDA-Approved Racially Targeted Rx Drug Related to Cost, Marketing, Newark Star-Ledger Finds
The Newark Star-Ledger on Saturday examined the "convergence of factors" that led to the "lackluster" performance of congestive heart failure medication BiDil, the first race-specific FDA-approved drug (Stewart, Newark Star-Ledger, 5/31). FDA in June 2005 approved BiDil for use in black patients based on the results of a clinical trial that found the medication reduced deaths by 43% within one year of use among black patients who had taken other treatments.
Analysts had estimated that BiDil would have sales of $130 million in 2006, but the medication actually registered sales of only $12.1 million that year. Since its approval, BiDil has reached only about 1% of the 750,000 U.S. blacks with congestive heart failure.
In January, the drug's manufacturer, NitroMed, announced plans to end all promotional activities of the drug (Kaiser Health Disparities Report, 1/16). Earlier this month, NitroMed reported slight increases in sales and revenue of BiDil, the Star-Ledger reports. The company does not plan to take the drug off the market.
Factors Behind Slow Sales
Many doctors contend that the drug's lagging sales are in part because BiDil is marketed specifically as a drug for blacks. Keith Ferdinand -- chief science officer for the Association of Black Cardiologists, which co-sponsored the trial that led to BiDil's approval -- said he wonders whether the drug would have been more successful if it were marketed toward the general population, allowing the specific effect in blacks to "stand on its own."
Cost and patient compliance with BiDil regimens also played a role in low sales, according to the Star-Ledger. Marc Klapholz, director of cardiology at The University Hospital in Newark and a BiDil researcher, said, "With [black] patients, a greater degree are also socioeconomically challenged, so the added expense did not make it any easier either." BiDil, which is taken three times daily, costs $1.80 per pill. NitroMed is working on developing an extended release form of BiDil that can be taken once daily.
Some doctors also question whether the drug is needed because most patients who are prescribed BiDil take the medication in conjunction with other heart failure treatments, according to the Star-Ledger (Newark Star-Ledger, 5/31).
Previous reports had cited coverage restrictions under the Medicare drug benefit and the availability of a generic alternative as other causes behind BiDil's slow sales (Kaiser Health Disparities Report, 1/16).
Ferdinand said, "It was really a significant advancement in the treatment of heart failure, but the unfortunate mixing of health economics, health policy and marketing led to its underutilization."
NitroMed officials said despite disappointing BiDil sales, it will continue development on the drug, noting that BiDil's performance will not hinder future racially targeted medications. Kenneth Bate, NitroMed's president and CEO, said, "With any new drug, it has been a gradual process" (Newark Star-Ledger, 5/31).