Intravenous Iron Replacement Therapy

POLICY NUMBER

L.5.01.610

Feraheme

(ferumoxytol)

Ferrlecit

(sodium ferric gluconate complex)

Injectafer (ferric carboxymaltose)

Monoferric (ferric derisomaltose)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific individual’s benefit plan.

DESCRIPTION

Iron deficiency is the most common nutritional deficiency worldwide. Major causes include decreased dietary intake, reduced absorption, and blood loss. Iron deficiency is also common in pregnancy due to increased iron requirements. Symptoms of iron deficiency anemia (IDA) vary but may include fatigue, weakness, headache, irritability, decreased exercise tolerance, and pica. While the cause of iron deficiency must be identified and addressed, iron replacement therapy is required to reduce the risk of anemia complications and improve quality of life. Treatment is usually initiated with oral iron supplementation; however, intravenous (IV) iron supplementation may be required if a patient cannot tolerate oral iron formulations, if iron loss exceeds oral iron absorption, or if oral iron will likely not be effective due to impaired absorption. Multiple IV iron formulations are available that vary in cost, time of administration, and the number of doses required. The formulations are equally effective with similar safety profiles.

POLICY

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

The following medications are considered not medically necessary on all Blue Cross & Blue Shield of Mississippi formularies as there are other formulary alternatives available for the treatment of iron deficiency anemia:

• Feraheme (brand)

• Ferrlecit (brand)

• Injectafer (ferric carboxymaltose)

• Monoferric (ferric derisomaltose)

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

POLICY HISTORY

11/01/2024: New policy added. Effective 01/01/2025.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to add generic for Feraheme and Ferrlecit. Policy statements unchanged. Sources updated.

SOURCE(S)

1. Auerbach M, DeLoughery TG. Diagnosis of iron deficiency and iron deficiency anemia in adults. In: UpToDate, Connor RF (ed), Wolters Kluwer. Updated June 2025. Accessed June 25, 2025. https://www.uptodate.com/contents/diagnosis-of-iron-deficiency-and-iron-deficiency-anemia-in-adults

2. Auerbach M, DeLoughery TG. Treatment of iron deficiency and iron deficiency anemia in adults. In: UpToDate, Connor RF (ed), Wolters Kluwer. Updated June 2025. Accessed June 25, 2025. https://www.uptodate.com/contents/treatment-of-iron-deficiency-and-iron-deficiency-anemia-in-adults

3. Bazeley JW, et al. Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD: A Review. American Journal of Kidney Diseases, Volume 79, Issue 6, 868 – 876.

4. Cheema B, Chokshi A, Orimoloye O. et al. Intravenous Iron Repletion for Patients With Heart Failure and Iron Deficiency: JACC State-of-the-Art Review. JACC. 2024 Jun, 83 (25) 2674–2689.

   https://doi.org/10.1016/j.jacc.2024.03.431

5. DeLoughery TG, et al. AGA Clinical Practice Update on Management of Iron Deficiency Anemia: Expert Review. Clinical Gastroenterology and Hepatology, Volume 22, Issue 8, 1575 – 1583.

6. Feraheme prescribing information. AMAG Pharmaceuticals, Inc. June 2022. Last accessed June 2025.

7. Ferrlecit prescribing information. Sanofi-aventis U.S., LLC. May 2025. Last accessed June 2025.

8. Infed prescribing information. Allergan, Inc. August 2024.  Last accessed June 2025.

9. Injectafer prescribing information. American Regent, Inc. January 2025. Last accessed June 2025.

10. Monoferric prescribing information. Pharmacosmos Therapeutics, Inc.  September 2024. Last accessed June 2025.

11. US Preventive Services Task Force; Nicholson WK, Silverstein M, Wong JB, et al. Screening and supplementation for iron deficiency and iron deficiency anemia during pregnancy: US Preventive Services Task Force recommendation statement. JAMA. 2024;332(11):906-913. doi: 10.1001/jama.2024.15196.

12. Venofer prescribing information. American Regent, Inc. June 2022. Last accessed June 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

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