BiDil(R) Gains Broad Preferred Status on Pharmacy Benefit Plans
Monday September 24, 8:30 am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--NitroMed (NASDAQ: NTMD - News), said today that the reimbursement and formulary status of BiDil continues to improve. To date, approximately 80% of African Americans who have commercial and Medicare Part D and Medicaid prescription drug insurance coverage in the United States, have affordable access to BiDil. The company defines 'affordable' as Tier 2 status, meaning out-of-pocket co-payments for patients are approximately $25. BiDil®, the fixed-dose combination of isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD), is approved by the FDA as adjunct therapy in the treatment of heart failure in African Americans to improve survival, reduce hospitalization and improve patient functional status. Heart failure is a life threatening condition that disproportionately burdens African Americans.
"BiDil enjoys preferred formulary status on America's four largest Medicare Part D drug plans, and the two largest commercial drug plan providers," observed Gerald Bruce, NitroMed's Senior Vice President. "Additionally, BiDil is available at tier 2 through the two largest pharmacy benefit management formularies in the United States, and it is listed on the formularies of numerous hospitals that provide heart failure care to large numbers of African Americans. These strong coverage gains should once and for all put to rest the perception that BiDil is out of reach and costly. In fact, in many cases it is no more costly to patients than its untested component agents ISDN and HYD which the FDA has said are not bioequivalent to or substitutable for BiDil," he said. "Indeed, for the majority of patients, the out-pocket cost for evidence-based BiDil is less or comparable to the out-of-pocket cost of two prescription co-payments for the untested component agents."
The company said that the steady flow of clinical evidence supporting BiDil's efficacy, safety and its cost-effectiveness are factors in the strong contracting activity.
The company will issue a statement at 9:00 AM today regarding a published study on the use of BiDil's individual components that have not been shown to be bioequivalent to the fixed dose combination.
About NitroMed, Inc.
NitroMed of Lexington, Massachusetts is an emerging pharmaceutical company and the maker of BiDil® (isosorbide dinitrate/hydralazine hydrochloride), an orally administered medicine available in the United States for the treatment of heart failure in self-identified black patients. In this population, BiDil is indicated as an adjunct to current standard therapies such as angiotensin converting enzyme (ACE) inhibitors and beta blockers. There is little experience in patients with New York Heart Association Class IV heart failure. BiDil was approved by the U.S. Food and Drug Administration, primarily on the basis of efficacy data from the Company's landmark A-HeFT (African American Heart Failure Trial) clinical trial and is marketed by NitroMed through a specialty medicines sales organization.
For full prescribing information, visit: www.BiDil.com. BiDil is a registered trademark of NitroMed, Inc.
surf's up......crikey
AI
