Tuesday, December 8, 2015

Ferrlecit® and Venofer CPT CODE – J2916


Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity
The use of Ferrlecit® is covered as a first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

The use of Venofer® is covered as a first line treatment of iron deficiency anemia in patients undergoing chronic hemodialysis. The use of Venofer® for iron deficiency anemia will be covered in non-dialysis dependent chronic kidney disease patients.

The primary cause of anemia in patients with chronic renal failure is insufficient production of erythropoietin (EPO) by the diseased kidney. Iron deficiency is also a contributing factor or cause of anemia. In hemodialysis patients, anemia can be attributed to several factors including substantial loss of blood from frequent blood tests, blood remaining in the dialysis tubing and dialyzer, gastrointestinal blood losses and an increase in the rate of erythropoiesis on epotein therapy.

Ferrlecit (sodium ferric gluconate complex in sucrose) is a stable macromolecular complex consisting of mono and di-nuclear iron (III) oxide hydrates which are directly and covalently bonded to saccharates. Venofer (iron sucrose) is a complex of polynuclear iron (III)-hydroxide cores surrounded by non-covalently-bound sucrose molecules.

According to Drug Facts and Comparisons® 2005 e-facts, Ferrlecit, most patients will require a minimum cumulative dose of 1.0 gram of elemental iron, administered over eight sessions at sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response. The recommended dose for repletion therapy is 10 mL (125mg of elemental iron). Ferrlecit can be administered by slow IV injection undiluted solution at a rate of no greater than 1mL/min (12.5 mg elemental iron/min) max dose should not exceed 10mL (2 vials) or by IV infusion, dilute contents of 2 vial in 100mL 0.9% sodium chloride injection immediately prior to infusion and infuse over 1 hour. Patients may continue to require therapy with Ferrlecit or other iron preparations at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit and laboratory parameters of iron storage within acceptable limits.

According to Drug Facts and Comparisons® 2005 e-facts, Venofer, most CKD patients will require a minimum cumulative dose of 1,000 mg of elemental iron, administered over 10 sequential sessions to achieve a favorable hemoglobin or hematocrit response. Iron Sucrose may be administered either by slow IV injection or by IV infusion directly into the dialysis line. If by slow IV injection, Venofer must be given at a rate of 1mL (iron 20mg) undiluted solution per minute (ie, 5minutes/vial) not exceeding 1 vial of iron sucrose (elemental iron 100mg) per injection. If giving Venofer by infusion, the content of each vial should be diluted exclusively in a maximum of 100mL if 0.9% sodium chloride, immediately prior to infusion. Infuse the solution at a rate of 100mg of iron over 15 minutes.

For non-dialysis dependent chronic kidney disease patients, Venofer® is administered as a slow IV injection over 2-5 minutes on five (5) different occasions within a fourteen (14) day period. The total cumulative dose should be 1000 mg of Venofer®.

Patients may continue to require therapy with Venofer® or other intravenous iron preparations at the lowest dose necessary to maintain target levels of hemoglobin and laboratory parameters of iron storage within acceptable limits.

Dosages in excess of iron needs may lead to accumulation of iron storage sites and hemosidrosis. Periodic monitoring of laboratory parameters of iron storage levels may assist in recognition of iron accumulation. Ferrlecit and Venofer should not be administered to patients with iron overload.

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