CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1181

Iron Products (parenteral and oral iron therapies)

Defines accepted indications, dosing limits, and authorization criteria for iron products (listed brands and generics) for treatment of iron deficiency and related anemias; applies to utilization management and prescribing providers whose members receive coverage through Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIron Products (parenteral and oral iron therapies)

Policy CodePolicy UM ONC_1181

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with recent labs and documentation of oral iron failure or intolerance when requesting IV iron (CKD exception applies).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8listed iron products

May 31, 2024effective date

1–1,500 mgdose range (single/total)

Ferritin <30 or TSAT <20%primary lab thresholds

Coverage Criteria

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Covered indications

Covered when ANY of the following indication categories are met with required documentation:

Continuation therapy exemption: Continuation requests are exempt if all of the following are true: (1) the requested medication was used within the last year; AND (2) the member has not experienced disease progression and/or has no intolerance to the requested medication; AND (3) additional medication(s) are not being added to the continuation request.

Iron deficiency (general): Member has iron deficiency with or without anemia with the presence of ONE or MORE of: (a) serum ferritin <30 ng/mL; (b) transferrin saturation (TSAT) <20%; (c) absence of stainable iron in bone marrow; (d) improvement of anemia with iron replacement therapy (oral or parenteral).Ferritin <30 ng/mL or TSAT <20%

Chemotherapy-induced anemia: Member is receiving (or received within the last 8 weeks) myelosuppressive chemotherapy AND has chemotherapy-induced anemia defined as Hgb <10 g/dL OR HCT <30 (levels obtained within the last 4 weeks). Iron products may be used with or without concomitant ESA therapy. Acceptable labs include ferritin <30 ng/mL and/or TSAT <20% within the last 12 months.Hgb <10 g/dL or HCT <30; Ferritin <30 ng/mL or TSAT <20%

Anemia of chronic kidney disease (CKD): Member has CKD defined by GFR <60 mL/min AND Hgb <10 g/dL OR HCT <30 (levels obtained within the last 4 weeks). Parenteral iron products may be used with or without concomitant ESA therapy. Acceptable labs include ferritin <30 ng/mL and/or TSAT <20%.GFR <60 mL/min; Hgb <10 g/dL or HCT <30

Coverage excludes requests where dosing exceeds the product-specific single-dose or total replacement limits listed in the policy. Examples include: Accrufer — single dose > 30 mg or > 60 (30 mg) capsules/month; Infed — single dose > 100 mg or total replacement dose > 1,000 mg per course; Ferrlecit — single dose > 125 mg or total replacement dose > 1,000 mg per course; Venofer — single dose > 300 mg or total replacement dose > 1,000 mg per course; Injectafer — single dose > 750 mg or total replacement dose > 1,500 mg per course; Feraheme — single dose > 510 mg or total replacement dose > 1,020 mg per course; and Monoferric — single dose or total replacement dose > 1,000 mg.

In addition, requests for investigational or off-label uses of iron products that are not supported by sufficient evidence or not generally accepted by the medical community are excluded. The policy relies on recognized evidentiary sources to determine sufficiency, so uses lacking support in CMS-recognized compendia, accepted peer-reviewed literature, or other applied clinical criteria may be denied.

For any non–FDA-labeled (off-label) indication, the policy requires adequate supporting evidence from recognized sources. Acceptable support includes CMS-recognized compendia or acceptable peer-reviewed literature that demonstrate the patient population, treatment regimen, and clinically meaningful outcomes are represented in the evidence. The policy applies the listed evidentiary considerations (for example, representation of clinical characteristics and therapies, study outcomes that meet ASCO-defined clinically meaningful thresholds, and appropriate experimental design) when judging whether off-label use is supported.

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Evolent (UM) will process all requests for iron products — medications not authorized by Evolent may be deemed not approvable and not reimbursable. Continuation requests for medications previously used within the last year may be exempt when the member has not experienced disease progression or intolerance and no additional medications are being added.

Prior authorization required for new requests: Evolent (UM) processes and adjudicates all requests.
Continuation exemption: medication used within the last year, no disease progression or intolerance, and no additional meds added.

Documentation Required

Required Supporting Documentation

Documentation must include supporting labs and clinical sources to justify the requested therapy. Acceptable evidence includes FDA product labeling, CMS‑approved compendia, NCCN or ASCO guidelines, or peer‑reviewed literature meeting CMS criteria. Provide the specific indication, relevant lab values (dates and numeric results), prior therapies tried, and rationale if request exceeds usual dosing limits.

Required supporting documentation: recent hemoglobin/hematocrit (within 4 weeks) when applicable; ferritin and TSAT values (include dates; ferritin <30 ng/mL and/or TSAT <20% where indicated).
Cite guideline or compendia source when using off‑label indications (e.g., NCCN, ASCO, CMS compendia).
Include history of oral iron trial/failure or intolerance (see oral iron requirement), and documentation of prior IV doses if continuation.

Documentation Required

Oral Iron Trial/Failure Requirement

A documented trial and failure of, or intolerance to, oral iron is required prior to approval of intravenous iron products for iron deficiency or chemotherapy‑related anemia, except for members with anemia of chronic kidney disease (CKD) where this oral‑iron requirement is not required. Document duration, dose, adherence, reason for failure or intolerance (e.g., GI side effects, insufficient hemoglobin response) and dates of therapy.

Oral iron trial required prior to IV iron for iron deficiency and chemotherapy‑induced anemia.
Exception: anemia of chronic kidney disease — oral iron trial not required.
Document trial length, dose, adherence, and reason for failure/intolerance.

Denial Risk

Requests Exceeding Single‑Dose or Total Replacement Dose Limits

Requests that exceed single‑dose or total replacement dose limits for specific products require explicit justification and supporting documentation (see dosing exclusions). Provide clinical rationale, prior dosing history, and literature or guideline support for doses beyond standard limits. Without adequate justification these requests may be excluded from coverage.

If requesting doses above product limits (examples): Accrufer >30 mg single dose or >60 capsules/month; Infed single dose >100 mg or total replacement >1,000 mg; Ferrlecit single dose >125 mg or total replacement >1,000 mg; Venofer single dose >300 mg or total replacement >1,000 mg; Injectafer single dose >750 mg or total replacement >1,500 mg; Feraheme single dose >510 mg or total replacement >1,020 mg; Monoferric single dose or total replacement >1,000 mg.
Provide justification and supporting evidence when exceeding these limits.

Background

Iron products, available as oral and parenteral formulations, are used to treat iron deficiency with or without anemia and condition-specific anemias such as chemotherapy-induced anemia (CIA) and anemia of chronic kidney disease (CKD). Appropriate use is determined by clinical criteria and laboratory measures (for example, ferritin and transferrin saturation), and therapy selection (oral versus IV) follows documented indications and prior-treatment requirements in the policy.

The policy requires laboratory confirmation and clinical documentation for covered use. Typical thresholds used to define iron deficiency or related indications include ferritin <30 ng/mL or TSAT <20%, while anemia definitions referenced in the policy use hemoglobin <10 g/dL or hematocrit <30, and CKD is defined in part by GFR <60 mL/min. Where IV iron is requested, documentation of failure or intolerance to oral iron is required for most indications (with an exception for CKD).

The policy lists the specific iron products subject to these rules (for example, Infed, Venofer, Ferrlecit, Feraheme, Monoferric, Injectafer, and Accrufer) and ties coverage to meeting the stated clinical and laboratory criteria, prior-authorization procedures, and quantity/dose limits described elsewhere in the policy.

Definitions

Iron deficiency — Diagnostic criteria

Ferritin criterionSerum ferritin less than 30 ng/mL

TSAT criterionTransferrin saturation (TSAT) less than 20%

Bone marrow ironAbsence of stainable iron in the bone marrow

Therapeutic responseImprovement of anemia with iron replacement therapy (oral or parenteral)

Chemotherapy-induced anemia (CIA) — Definition

Chemotherapy exposureReceiving or received myelosuppressive chemotherapy within the last 8 weeks

Hemoglobin thresholdHgb less than 10 g/dL (labs within last 4 weeks)

Hematocrit thresholdHCT less than 30 (labs within last 4 weeks)

Adjunct labsAcceptable ferritin <30 ng/mL and/or TSAT <20% within the last 12 months

Anemia of chronic kidney disease (CKD) — Definition and therapy

GFR thresholdGFR less than 60 mL/min

Hemoglobin/HematocritHgb less than 10 g/dL OR HCT less than 30 (levels within last 4 weeks)

Role of parenteral iron/ESAParenteral iron products may be used with or without concomitant ESA therapy; exception to oral iron failure requirement applies in CKD

Step	Requirement	Exception / Notes
1	Documentation of prior trial of oral iron demonstrating failure or intolerance	Required prior to IV iron for indicated uses; exception for anemia of chronic kidney disease (CKD)

Product Quantity and Dose Limits

Accrufer (ferric maltol) — Quantity limits

Single-dose strength30 mg per capsule (Accrufer)

Monthly maximum60 capsules per month (maximum)

Dosing noteRequests exceeding these limits will be excluded

Infed (iron dextran) — Quantity limits

Single-dose strength100 mg per dose

Total replacement dose1,000 mg per course