National Coverage Analysis (NCA) Tracking Sheet

Venofer: Intravenous Iron Therapy

CAG-00080N

Issue

Venofer is an injectable iron product used for the treatment of iron deficiency anemia in end-stage renal disease (ESRD) patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin. Venofer was approved by the Food and Drug Administration (FDA) on November 6, 2000.

National Coverage Determinations

Benefit Category

Drugs and Biologicals

Requestor Information

Requestor Name Requestor Letter
Walter Tozzi, RPh, MS, MBA N/A
Nina Farzin, RPh, PharmD N/A
American Regent Laboratories, Inc. N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
11/13/2000
Expected NCA Completion Date
03/19/2001
Public Comment Period
12/13/2000 - 01/13/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
03/21/2001

Contacts

Lead Analysts
Poppy Kendall
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

November 13, 2000

Application received.

November 14, 2000

Formal request accepted for review. A letter will be sent to requestors notifying them of the acceptance of their application.

November 15, 2000

Referred to Center for Health Plans and Providers (CHPP) for final benefit category determination.

March 19, 2001

Decision made to issue a positive national coverage determination for iron sucrose for first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy. See Decision Memorandum  dated March 21, 2001.