Ferrlecit®: Intravenous Iron Therapy

Application received.

Formal request accepted for review.

Due date, revised. HCFA has extended its original decision date to January 31, 2000 while it continues to analyze issues of coverage. Particularly, we are interested in examining and comparing the conditions and the population for which sodium ferric gluconate is reasonable and necessary when compared with dextran iron injectables or with oral iron.

Questions in need of additional evidence:

(1) Is there any evidence that shows that sodium ferric gluconate is safer then oral iron therapy? Is there any evidence that shows sodium ferric gluconate is not riskier then oral iron?

(2) What is the evidence that sodium ferric gluconate is more effective than oral iron or can a population be defined for which this is so? What is the added value of IV iron as a first-line therapy option without a trial of oral iron?

(3) Is there a definable subset of anemic ESRD patients who should not be tried on oral iron before injectable?

(4) What is the evidence supporting the statement made in the normal request that "patients with functional iron deficiency do not meet laboratory criteria for absolute iron deficiency, but demonstrate an increase in hemoglobin/hematocrit or a decrease in rHuEPO dosage with stable hemoglobin/hematocrit when parenteral iron is administered"?

2000 Schein Pharmaceuticals, Inc. submitted evidence.

2000 American Regent Laboratories, Inc. submitted evidence.

Due date revised to May 10, 2000 in light of new evidence from Schein Pharmaceuticals, Inc. and American Regent Laboratories, Inc.

Decision made to issue a positive national coverage determination for sodium ferric gluconate complex in sucrose injection for either first or second line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoeitin therapy. See Decision Memorandum dated April 20, 2000.

Letter sent to requestor informing of decision.