NitroMed, Inc. announced today that BiDil® (isosorbide dinitrate/hydralazine hydrochloride) is being launched for the treatment of heart failure in black patients as an adjunct to current standard therapies. BiDil was approved by the U.S. Food and Drug Administration (FDA) on June 23, 2005.
Today, NitroMed also announced BiDil pricing and its plans to implement a Patient Assistance Program (PAP) to ensure that BiDil is available to all patients who need it regardless of income level or health insurance status.
“NitroMed is pleased to be able to make BiDil available within one year of the African American Heart Failure Trial (A-HeFT) being halted and within only two weeks of FDA approval. This speaks to NitroMed’s sense of urgency and to the importance of BiDil to the patients who need it,” said Michael D. Loberg, Ph.D., President and CEO of NitroMed. “In addition, we are proud to be announcing our goal to implement what we expect will be an industry-leading Patient Assistance Program. This program is intended to ensure that the life-extending benefits of BiDil will be available to each and every black patient with heart failure.”
BiDil will be priced at a wholesale acquisition cost (WAC) of $1.80 per tablet and supplied to the pharmacist in bottles of 180 tablets. NitroMed expects that BiDil starter samples will be available in doctors’ offices the week of July 5th, with commercial product available in pharmacies beginning the following week.
NitroMed is implementing a PAP with benefits that it believes will provide the greatest and easiest access to medication in the pharmaceutical industry. The intent of the program is to ensure that all uninsured patients have affordable access to BiDil.
Through the BiDil PAP, NitroMed expects to make BiDil available free-of-charge to patients without insurance coverage whose annual household incomes are up to three times the poverty level. For all others without insurance coverage, NitroMed expects to make BiDil available for $25 per prescription, which is consistent with the co-payment typically charged by private insurance for tier II, or preferred branded drugs.
The co-chairs of the National Minority Health Month Foundations' Minority Coalition for Prescription Drug Assistance, former U.S. Representative Peter Deutsch and NAACP board member and Health Committee Chair Rupert Richardson, applauded NitroMed's new initiative in a statement released today.
“The Minority Coalition for Prescription Drug Assistance commends NitroMed for its commitment in organizing a ground-breaking patient assistance program to ensure that all indicated patients who are affected by heart failure, and in need of support, have access to this new, life-saving medication. Our coalition, including organizations like the National Medical Association and the National Association for the Advancement of Colored People, is working closely with NitroMed on this program to ensure that every individual at risk is aware of this important resource.”