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Intravenous Iron Replacement Therapy

Page 1 of 5 Coverage Policy Number: IP0222 Drug and Biologic Coverage Policy Effective Date .. 1/1/2022 Next Review .. 1/1/2023 Coverage Policy Number .. IP0222 Intravenous iron Replacement Therapy Table of Contents Overview .. 1 Medical Necessity Criteria .. 2 Reauthorization Criteria .. 2 Authorization Duration .. 2 Conditions Not 2 Coding / Billing Information .. 2 Background .. 3 References .. 5 Related Coverage Resources INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations.

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. ... infusion within a 28-day period: two 300 mg infusions over 1.5 hours 14 days apart, then one 400 mg infusion over 2.5 hours 14

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  Iron, Infusion, Ferric, Ferric carboxymaltose, Carboxymaltose

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Transcription of Intravenous Iron Replacement Therapy

1 Page 1 of 5 Coverage Policy Number: IP0222 Drug and Biologic Coverage Policy Effective Date .. 1/1/2022 Next Review .. 1/1/2023 Coverage Policy Number .. IP0222 Intravenous iron Replacement Therapy Table of Contents Overview .. 1 Medical Necessity Criteria .. 2 Reauthorization Criteria .. 2 Authorization Duration .. 2 Conditions Not 2 Coding / Billing Information .. 2 Background .. 3 References .. 5 Related Coverage Resources INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations.

2 References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy.

3 In the event of a conflict, a customer s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans.

4 Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Overview This policy supports preferred product review, where required by specific plan, for the following Intravenous iron Replacement Therapies: Feraheme (ferumoxytol) Injectafer ( ferric carboxymaltose ) Monoferric ( ferric derisomaltose) Page 2 of 5 Coverage Policy Number: IP0222 Medical Necessity Criteria Coverage for Intravenous iron Replacement Therapy varies across plans and may require the use of preferred products.

5 Refer to the customer s benefit plan document for coverage details. Employer Group Plans and Individual and Family Plans Non-Preferred Products and Preferred Alternatives by Plan: Non-Preferred Product Standard / Performance Value / Advantage Cigna Total Savings Legacy Individual and Family Plans Feraheme (ferumoxytol) ONE of the following (1, 2, or 3): 1. Documented inadequate efficacy, contraindication according to FDA label, significant intolerance, or is not a candidate* for Venofer ( iron sucrose) 2. Individual has iron Deficiency Anemia secondary to Chronic Kidney Disease and is on Dialysis 3. Individual has initiated Therapy with Feraheme, Injectafer, or Monoferric Injectafer ( ferric carboxymaltose ) Monoferric ( ferric derisomaltose) *Note: Not a candidate due to being subject to a warning per the prescribing information (labeling), having a disease characteristic, individual clinical factor[s], other attributes/conditions, or is unable to administer and requires this dosage formulation).

6 When coverage is available and medically necessary, the dosage, frequency, duration of Therapy , and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to Therapy . Note: Receipt of sample product does not satisfy any criteria requirements for coverage. Reauthorization Criteria Intravenous iron Replacement Therapy is considered medically necessary for continued use when initial criteria are met AND there is documentation of beneficial response. Authorization Duration Initial approval duration is up 12 months.

7 Reauthorization approval duration is up to 12 months. Conditions Not Covered Any other exception is considered not medically necessary. Coding / Billing Information Note: 1) This list of codes may not be all-inclusive. 2) Deleted codes and codes which are not effective at the time the service is rendered may not be eligible for reimbursement. Page 3 of 5 Coverage Policy Number: IP0222 Considered Medically Necessary when criteria in the applicable policy statements listed above are met: HCPCS / CPT Codes Description J1437 Injection, ferric derisomaltose, 10 mg J1439 Injection, ferric carboxymaltose , 1 mg Q0138 Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (non-esrd use) Q0139 Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (for esrd on dialysis) Background OVERVIEW All iron Replacement products are used for the treatment of iron deficiency Feraheme, Injectafer, Monoferric, and Venofer are indicated in patients with chronic kidney disease (CKD).

8 Some are noted to be used in certain types of CKD as follows: Injectafer and Monoferric in patients who have non-dialysis dependent CKD; Venofer in patients with hemodialysis-dependent CKD, non-dialysis dependent CKD, and peritoneal dialysis-dependent CKD. All of these agents are administered intravenously. Injectafer and Feraheme are recommended to be given only as two doses; the other products generally have lower doses of iron given multiple times over longer periods of time. Feraheme is only recommended to be given as an Intravenous infusion over at least 15 minutes. Venofer has recommended dosing for selected indications in patients aged 2 years.

9 FDA-Approved Indications of the Injectable iron Replacement Indications Description/ Mechanism of Action Feraheme (ferumoxytol injection) Treatment of IDA in adults who have: Intolerance to oral iron or have had unsatisfactory response to oral iron CKD Feraheme is a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron -carbohydrate complex enters the reticuloendothelial system. Injectafer ( ferric carboxymaltose injection) Treatment of IDA in adults patients who have: Intolerance to oral iron or have had unsatisfactory response to oral iron NDD-CKD ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose , a carbohydrate polymer that releases iron .

10 Monoferric ( ferric derisomaltose injection) Treatment of IDA in patients 18 years of age who have: Intolerance to oral iron or have had unsatisfactory response to oral iron NDD-CKD A complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron . iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin. Venofer ( iron sucrose injection) Treatment of IDA in patients with CKD. Dosing information is provided regarding the following patient populations: Adults with HDD-CKD Adults with NDD- CKD Adults with PDD-CKD Pediatric patients ( 2 years of age) with HDD-CKD for iron maintenance treatment The agent is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose.


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