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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-10

Original Effective Date: 02/12/14

Reviewed: 04/08/15

Revised: 11/01/15

Subject: Ferric carboxymaltose (Injectafer®)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates
           

DESCRIPTION:

Iron deficiency anemia (IDA) is the most common cause of anemia worldwide and is most often due to blood loss or chronic dietary insufficiency; it may be diagnosed when iron deficiency is accompanied by anemia. Anemia may be a relatively nonspecific finding and further testing is necessary to establish the specific etiology of iron deficiency. Tests to further identify the cause as iron deficiency include serum iron, total iron binding capacity (TIBC), ferritin, serum transferrin receptor, and transferrin saturation. Low serum iron in the presence of elevated total iron-binding capacity and low serum ferritin is considered diagnostic for iron deficiency. A ferritin level of 15 mcg/L or less is a marker of depleted or absent iron stores, and confirms iron deficiency anemia in the presence of low hemoglobin.

Current treatment options for IDA include oral iron (as ferrous sulfate) and a number of injectable iron products, including sodium ferric gluconate (Ferrlecit), iron sucrose (Venofer), iron dextran (INFeD, Dexferrum), and ferumoxytol (Feraheme). Ferric carboxymaltose (Injectafer®) was approved by the U.S. Food and Drug Administration (FDA) in July 2013 as a parenteral iron replacement product for the treatment of IDA.

The safety and effectiveness of ferric carboxymaltose were evaluated in a randomized, open-label clinical trial of patients with iron deficiency anemia (hemoglobin < 12 g/dL, ferritin < 100 ng/mL) with an unsatisfactory response (n=495) or intolerance (n=482) to oral iron. All participants received 14 days of oral iron. Participants who had an unsatisfactory response to oral iron were randomized to receive ferric carboxymaltose IV (n=244) 15 mg/kg every 7 days for two doses or oral iron (n=251) for 14 days. Participants who were intolerant to oral iron were randomized to either ferric carboxymaltose IV (n=245) 15 mg/kg every 7 days for two doses or to another IV iron product (n=237; 90% received iron sucrose). Changes in hemoglobin levels from baseline to the highest value between baseline and day 35 were significantly greater with ferric carboxymaltose than with comparator in both cohorts (Table 1).

Table 1

Table 1. Mean Change (SD) in Hemoglobin Levels From Baseline (Modified Intent-to-Treat Population)

 

Unresponsive to Oral Iron

Intolerant of Oral Iron

 

Injectafer (n=244)

Oral Iron (n=251)

Injectafer (n=245)

IV Iron (n=237)

Baseline hemoglobin (SD)

10.6 (1)

10.6 (1)

9.1 (1.6)

9 (1.5)

Highest hemoglobin (SD)

12.2 (1.1)

11.4 (1.2)

12 (1.2)

11.2 (1.3)

Change from baseline to highest value (SD)*

1.6 (1.2)

0.8 (0.8)

2.9 (1.6)

2.2 (1.3)

* p=0.001 for comparisons of change from baseline to highest value in both groups

Ferric carboxymaltose may cause hypertension (3.8% of patients treated with the agent in clinical trials) and serious hypersensitivity reactions, including anaphylaxis. Overestimation of serum or transferrin-bound iron may occur on laboratory assays for 24 hours post-administration.

POSITION STATEMENT:

Ferric carboxymaltose meets the definition of medical necessity when ALL of the following criteria are met:

1. Indication for use is iron deficiency anemia

2. Member has laboratory documented anemia (i.e., measured hemoglobin is below the laboratory’s lower limit of normal)

3. Member has laboratory documented iron deficiency defined as ONE of the following:

a. Measured ferritin level is less than 15 mcg/L

b. Measured serum iron level AND transferrin saturation level are below the laboratory’s lower limit of normal AND measured total iron-binding capacity is above the laboratory’s upper limit of normal

4. Member meets ONE of the following:

a. Member is diagnosed with chronic kidney disease and is not dependent on dialysis

b. Member has tried and failed four week trial of oral iron therapy

c. Member has a contraindication or intolerance to treatment with oral iron

5. Dose does not exceed 750 mg every 7 days

6. Member is 18 years of age or older

Duration of approval: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING IT’S USAGE.

FDA-approved

• Weight 50 kg (110 lb) or more: 750 mg IV every 7 days x 2 doses (total dose 1500 mg per course)

• Weight less than 50 kg (110 lb): 15 mg/kg IV every 7 days x 2 doses

• Treatment may be repeated if iron deficiency anemia reoccurs.

Dose Adjustments
None

Drug Availability

750 mg iron/15 mL single-use vial

PRECAUTIONS:

Boxed Warning

None

Contraindications

Hypersensitivity

Precautions/Warnings

• Hypersensitivity: Monitor during and after administration for at least 30 minutes

• Hypertension

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J1439

Injection, ferric carboxymaltose, 1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

D50.0

Iron deficiency anemia secondary to blood loss (chronic)

D50.1

Sideropenic dysphagia

D50.8

Other iron deficiency anemias

D50.9

Iron deficiency anemia, unspecified

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

Chronic Renal Failure (CRF): the Glomerular Filtration Rate (GFR) is less than 20 to 25% of normal. The kidneys cannot regulate volume and solute composition and patients develop edema, metabolic acidosis and hypocalcemia.

Erythroid: pertaining to any of the cells in the developmental series ending in erythrocytes.

Erythropoietin: a protein naturally made in the kidneys, which acts on the bone marrow to stimulate the body’s production of red blood cells.

ESRD: end-stage renal disease (kidney failure).

Hematocrit: a method for determining the volume of packed red blood cells in a blood specimen.

Hemoglobin: a method for measuring the oxygen carrying capacity of the red blood cells.

Renal failure: kidney failure, often requiring dialysis.

RELATED GUIDELINES:

Erythropoiesis Stimulating Agents (09-J0000-31)

OTHER:

None

REFERENCES:

  1. American Regent, Inc. Injectafer (ferric carboxymaltose injection) injection, solution. 2013 [cited 2013 Dec 31]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=517b4a19-45b3-4286-9f6a-ced4e10447de/.
  2. Centers for Disease Control: Recommendations to prevent and control iron deficiency in the United States.. MMWR Recomm Rep 1998; 47(RR-3):1-29.
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2015 [cited 2015-03-23]. Available from: http://www.clinicalpharmacology.com/.
  4. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2015-03-23]. Available from: http://clinicaltrials.gov/.
  5. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically 2015 [cited 2015-03-23]. Available from: http://www.thomsonhc.com/.
  6. Goddard AF, James MW, McIntyre AS, Scott BB; British Society of Gastroenterology. Guidelines for the management of iron deficiency anaemia. Gut. 2011 Oct;60(10):1309-16.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2015 [cited 2015-03-23]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 04/08/15.

GUIDELINE UPDATE INFORMATION:

03/15/14

New Medical Coverage Guideline.

07/01/14

Quarterly coding update.

01/01/15

Revision to guideline; consisting of annual HCPCS coding update.

05/15/15

Revision to guideline; updated references.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: October 17, 2017: 04:27 PM