CurrentCentenePolicy CP.PHAR.480

Ferric Derisomaltose (Monoferric)

Criteria and prior authorization requirements for coverage of ferric derisomaltose (Monoferric) for treatment of iron deficiency anemia and related indications for Centene lines of business.

Policy Summary

PayerCentene

PolicyFerric Derisomaltose (Monoferric)

Policy CodePolicy CP.PHAR.480

Change TypeNo material changes

Effective DateJun 1, 2020

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets clinical criteria and required prior therapy trials or contraindications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1000 mgMaximum single dose for adults ≥50 kg

J1437HCPCS code

AdultsFDA-indicated population

12 moStandard approval (Medicaid/HIM)

6 moStandard approval (Commercial)

Coverage Criteria

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Initial Therapy — Iron Deficiency Anemia with CKD

Covered when ALL of the following are met

IDA with CKD initial: 1. Diagnosis of iron deficiency anemia (IDA) and chronic kidney disease (CKD).

IDA with CKD initial: 2. IDA is confirmed by either: (a) transferrin saturation (TSAT) ≤ 30% OR (b) serum ferritin ≤ 500 ng/mL.

IDA with CKD initial: 3. If CKD is non-hemodialysis/non-peritoneal dialysis, oral iron therapy is not optimal due to one or more of: TSAT <12%; Hgb <7 g/dL; symptomatic anemia; severe/ongoing blood loss; oral iron intolerance; inability to achieve therapeutic targets with oral iron; or a co-existing condition refractory to oral iron.

IDA with CKD initial: 4. Step therapy: member meets BOTH of the following: (a) failure of both Ferrlecit and iron sucrose (Venofer) unless clinically significant adverse effects or contraindications; AND (b) if criterion 4a met, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced.

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 (IL HB 5395).

IDA with CKD initial: 5. Dose does not exceed 1,000 mg elemental iron per infusion/injection.dose ≤1000 mg

Initial Therapy — Iron Deficiency Anemia without CKD

Covered when ALL of the following are met

IDA without CKD initial: 1. Diagnosis of IDA confirmed by any of: (a) serum ferritin <15 ng/mL (or <30 ng/mL if pregnant); (b) serum ferritin ≤41 ng/mL and Hgb <12 g/dL (women) / <13 g/dL (men); (c) TSAT <20%; (d) absence of stainable iron in bone marrow; (e) increased soluble transferrin receptor (sTfR) or sTfR–ferritin index; (f) increased erythrocyte protoporphyrin level.

IDA without CKD initial: 2. Oral iron therapy is not optimal due to one or more of: TSAT <12%; Hgb <7 g/dL; symptomatic anemia; severe/ongoing blood loss; oral iron intolerance; inability to achieve therapeutic targets with oral iron; or a co-existing condition refractory to oral iron.

IDA without CKD initial: 3. At time of request, member does NOT have CKD.

IDA without CKD initial: 4. Step therapy: member meets BOTH of the following: (a) failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless clinically significant adverse effects or all are contraindicated; AND (b) if criterion 4a met, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced.

Initial Therapy — Cancer- and Chemotherapy-Induced Anemia (off-label)

Covered when ALL of the following are met (off-label management)

Cancer/Chemotherapy-induced anemia initial: 1. Diagnosis of iron deficiency with one of the following iron statuses: (a) absolute iron deficiency: ferritin <30 ng/mL AND TSAT <20%; OR (b) possible functional iron deficiency: ferritin 500–800 ng/mL AND TSAT <50%; OR (c) functional iron deficiency: ferritin 30–500 ng/mL AND TSAT <50% with an erythropoietin‑stimulating agent prescribed in combination.

Cancer/Chemotherapy-induced anemia initial: 2. Prescribed by or in consultation with an oncologist.

Cancer/Chemotherapy-induced anemia initial: 3. Member is prescribed chemotherapy for cancer.

Cancer/Chemotherapy-induced anemia initial: 4. Step therapy: failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless clinically significant adverse effects or all are contraindicated; AND if criterion 4a met, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced.

Continuation Therapy — Iron Deficiency Anemia with CKD

Covered when ALL of the following are met

CKD continuation: 1. Member is currently receiving Monoferric via Centene benefit or previously met initial approval criteria OR is in a continuity-of-care situation per state addenda.

CKD continuation: 2. Documentation since the last IV iron administration of one of: TSAT ≤30% OR serum ferritin ≤500 ng/mL.

CKD continuation: 3. Member meets BOTH of the following step therapy conditions: (a) failure of both Ferrlecit and iron sucrose (Venofer) unless clinically significant adverse effects or contraindications; AND (b) if criterion 3a met, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced.

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 (IL HB 5395).

CKD continuation: 4. If request is for a dose increase, the new dose does not exceed 1,000 mg elemental iron per infusion/injection.

Continuation Therapy — Iron Deficiency Anemia without CKD

Covered when ALL of the following are met

Non-CKD continuation: 1. Member is currently receiving Monoferric via Centene benefit or previously met initial approval criteria OR is in a continuity-of-care situation per state addenda.

Non-CKD continuation: 2. Documentation since the last IV iron administration of one of: serum ferritin <15 ng/mL (or <30 ng/mL if pregnant) OR serum ferritin ≤41 ng/mL and Hb <12 g/dL (women)/<13 g/dL (men) OR TSAT <20% OR absence of stainable iron in bone marrow OR increased sTfR or sTfR–ferritin index OR increased erythrocyte protoporphyrin level.

Non-CKD continuation: 3. At time of request, member does NOT have CKD.

Non-CKD continuation: 4. Step therapy: failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless clinically significant adverse effects or all are contraindicated; AND if criterion 4a met, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced.

Continuation Therapy — Cancer- and Chemotherapy-Induced Anemia

Covered when ALL of the following are met

Cancer continuation: 1. Member is currently receiving Monoferric via Centene benefit or documentation supports member has received Monoferric for a covered indication for at least 30 days.

Cancer continuation: 2. Member is responding positively to therapy (documented benefit).

Cancer continuation: 3. Step therapy: failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless clinically significant adverse effects or all are contraindicated; AND if criterion 3a met, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced.

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 (IL HB 5395).

Cancer continuation: 4. If request is for a dose increase, the new dose is within FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines/peer‑reviewed literature for the relevant off‑label use and prescriber has submitted supporting evidence; prescribed regimen must be FDA‑approved or NCCN‑recommended.

Coverage criteria (summary)

Summary of coverage-relevant dosing, prior therapy failures, and stepwise redirection

Dosing and availability summary: For IDA dosing: adults ≥50 kg = 1,000 mg IV single dose; <50 kg = 20 mg/kg IV single dose. Maximum single dose = 1,000 mg per infusion; product available in single‑dose vials: 1,000 mg/10 mL, 500 mg/5 mL, 100 mg/mL.

Step therapy / prior failures summary: Policy requires documented failure/intolerance/contraindication to preferred injectable iron agents prior to approval: for IDA with CKD failure of Ferrlecit and Venofer; for IDA without CKD failure of two of Ferrlecit, Infed, or Venofer. If preferred agents are intolerant/contraindicated, redirection to generic Feraheme is required in stepwise fashion.

Approval durations summary: Approval durations vary by line of business: Medicaid/HIM/ICHRA generally 12 months; Commercial generally 6 months or to the member's renewal date, whichever is longer (specific indications may have different durations as noted in the policy).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, or CP.PMN.53 for Medicaid, or unless an applicable evidence‑of‑coverage document permits coverage.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules that supersede this policy.

Uses for non‑FDA approved indications that lack sufficient documentation of efficacy and safety per the referenced off‑label use policies are not authorized. Providers must submit supporting clinical evidence in accordance with the applicable off‑label policy to request coverage for off‑label indications.

Use of ferric derisomaltose (Monoferric) is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Requests for therapy in patients with this contraindication are not medically appropriate and may be denied.

Initial Therapy

Initial therapy — top-level requirement that ALL criteria and step therapy per indication be met

Initial therapy is authorized only when ALL listed clinical and step therapy criteria for the requested indication are met

Initial therapy top-level: Provider must document that the member meets all indication‑specific clinical criteria (diagnostic lab thresholds, reasons oral iron is not optimal) AND the step therapy/prior failure requirements for the indication prior to initial approval.

Initial therapy dosing limit: Requested dose must not exceed the policy maximum of 1,000 mg elemental iron per infusion/injection (10 mL).dose ≤1000 mg

Initial therapy requirements (summary from history) — prior failure of preferred injectables

Provider must document prior failure, intolerance, or contraindication to preferred injectable IV iron agents as specified for each indication

Prior failure summary: For IDA with CKD: documented failure of Ferrlecit and iron sucrose (Venofer) is required unless adverse effects/contraindication. For IDA without CKD: documented failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) is required unless adverse effects/contraindication. For cancer/chemotherapy‑induced anemia: documented failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) is required unless adverse effects/contraindication.

If preferred agents are intolerant/contraindicated, redirection to generic Feraheme is required per stepwise policy language.

Continuation / Renewal Criteria

Continuation therapy — documentation of ongoing benefit and lab monitoring required

Continuation/renewal coverage requires documentation of ongoing benefit and recent laboratory monitoring since the last IV iron administration

Continuation requirement general: Member must be currently receiving Monoferric via the Centene benefit or have previously met initial approval criteria (or be in continuity-of-care). Provider must submit labs obtained since the last IV iron demonstrating the indication‑specific thresholds and documentation of clinical response where required.

Continuation step therapy: Continuation requests must also document prior failure/intolerance/contraindication to the preferred injectable agents per indication (same step therapy expectations as initial therapy).

Continuation therapy / approval durations — approval durations vary by line of business

Approval durations vary by line of business and indication

Approval durations for anemia associated with CKD and cancer/chemotherapy: Medicaid/HIM/ICHRA = 12 months; Commercial = 6 months or to the member's renewal date, whichever is longer. Specific initial approvals for cancer/chemotherapy may include shorter initial approval (e.g., 3 months) as noted in indication sections.

Step Therapy and Preferred Agents

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document prior trials and failures (or contraindications/adverse reactions) of specified preferred IV iron agents per indication before approval. Requests lacking supporting documentation of prior trials/failures, contraindications, or required laboratory results are at risk of denial or will be returned for additional information.

Affected products: Ferrlecit (iron sucrose complex), iron sucrose (Venofer), Infed (iron dextran), generic Feraheme (ferumoxytol)
Step requirements vary by indication (see below).
Laboratory documentation required: TSAT and/or serum ferritin per indication; labs must be measured since the last IV iron administration when applicable.

Denial Risk

Requests Lacking Supporting Documentation / Contraindication Triggers Denial

If the request does not include documentation of prior trials/failures of the listed preferred agents, or documentation that those agents are contraindicated or caused clinically significant adverse effects, the request may be denied or redirected. Contraindications to the preferred agents must be explicitly documented to avoid denial.

Requests without documentation of trials/failures of required comparators (e.g., Ferrlecit and Venofer for IDA with CKD; two of Ferrlecit, Infed, or Venofer for IDA without CKD) will be considered incomplete.
If member experienced clinically significant adverse effects to preferred agents, provider must document the reaction(s).
Explicit documentation that preferred agents are contraindicated is required; absence of contraindication documentation may lead to denial or redirection to preferred agents.

Step Therapy

Step Therapy and Preferred Agents

Step therapy: providers must document failure (or intolerance/contraindication) of the specified preferred agents before approval. For IDA with CKD, failure of both Ferrlecit and iron sucrose (Venofer) is required; if those are failed or contraindicated, failure of generic Feraheme is required before approval. For IDA without CKD, failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) is required; if those are failed or contraindicated, failure of generic Feraheme is required before approval. For cancer- and chemotherapy-induced anemia (NCCN-supported indication/off-label), failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) is required; if those are failed or contraindicated, failure of generic Feraheme is required. Dose limits and coding: provider must document proposed elemental iron dose (not to exceed 1000 mg elemental iron / 10 mL per infusion) and include appropriate billing codes/NDCs.

IDA with CKD: document failure/intolerance/contraindication to Ferrlecit and iron sucrose (Venofer); if met, document failure/intolerance/contraindication to generic Feraheme before approval.
IDA without CKD: document failure/intolerance/contraindication to two of Ferrlecit, Infed, or iron sucrose (Venofer); if met, document failure/intolerance/contraindication to generic Feraheme before approval.
Cancer- and chemotherapy-induced anemia (NCCN-supported or off-label per policy): document failure/intolerance/contraindication to two of Ferrlecit, Infed, or iron sucrose (Venofer); if met, document failure/intolerance/contraindication to generic Feraheme before approval.
Required lab documentation: TSAT and/or serum ferritin per indication (e.g., TSAT ≤30% or ferritin ≤500 ng/mL for many IV iron approvals; see initial criteria).
Dose documentation: proposed elemental iron dose must be stated; dose increases must not exceed 1000 mg elemental iron (10 mL) per infusion/injection unless supported by FDA limits or clinical literature for off-label uses with supporting evidence.

Coding and Lab Thresholds

HCPCS CodesHCPCS

J1437

Injection, ferric derisomaltose, 10 mg

TSAT thresholds referenced across indications

TSAT threshold for IDA with CKDTSAT ≤ 30% confirms IDA for IDA with CKD

TSAT threshold for IDA without CKDTSAT < 20% confirms IDA for IDA without CKD and continuation criteria

TSAT threshold for cancer/chemotherapy-induced anemia (absolute deficiency)TSAT < 20% (with ferritin < 30 ng/mL)

TSAT threshold for possible functional deficiency (cancer setting)TSAT < 50% when ferritin 500–800 ng/mL or 30–500 ng/mL with ESA therapy

TSAT value triggering oral iron not optimalTSAT < 12% listed as a reason oral iron is not optimal

Serum ferritin thresholds referenced across indications

Serum ferritin threshold (IDA without CKD)Serum ferritin < 15 ng/mL (or < 30 ng/mL if pregnant) confirms IDA

Serum ferritin threshold with low HgbSerum ferritin ≤ 41 ng/mL when Hgb < 12 g/dL (women) / < 13 g/dL (men) confirms IDA

Ferritin thresholds for cancer/chemotherapy-induced anemiaAbsolute: ferritin < 30 ng/mL; Possible functional: ferritin 500–800 ng/mL; Functional: ferritin 30–500 ng/mL

Ferritin threshold for CKD criteriaSerum ferritin ≤ 500 ng/mL can confirm IDA in CKD indication

Hemoglobin (Hgb) thresholds referenced in criteria

Hgb threshold as reason oral iron not optimalHgb < 7 g/dL listed as a reason oral iron is not optimal for multiple indications

Sex-specific diagnostic Hgb thresholds (non-CKD)Hgb < 12 g/dL (women) or < 13 g/dL (men) in combination with ferritin ≤ 41 ng/mL

Hgb referenced in appendix abbreviationsHgb defined as hemoglobin in Appendix A

Most actionable Hgb trigger for therapy escalationHgb < 7 g/dL — use IV iron considerations and step therapy exceptions

Maximum single dose — 1,000 mg per dose

Maximum single-dose limitDose does not exceed 1000 mg elemental iron (10 mL) per infusion/injection

FDA maximum per dose noteIDA maximum dose = 1,000 mg per dose; treatment may be repeated as needed

Documentation requirement for dose increasesIf request is for a dose increase, new dose must not exceed 1,000 mg per infusion/injection

Quantity Limits

ferric derisomaltose (Monoferric) — 1000 (quantity limit summary)

Quantity limit (elemental iron)1000 mg elemental iron per infusion/injection

Per-dose specificationMaximum single dose 1,000 mg (10 mL) per administration

Repeat dosingTreatment may be repeated if IDA reoccurs, within per-dose maximum

Ferric derisomaltose (Monoferric) — 1,000 mg per dose

Per-dose strength1,000 mg IV as a single dose for adults ≥ 50 kg

Alternative weight-based dose< 50 kg: 20 mg/kg actual body weight IV as a single dose

Dose volume equivalence1,000 mg corresponds to 10 mL of product (10 mg/mL concentration) per policy dosing section

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required. Requests must document that the member meets the listed clinical criteria including diagnosis, laboratory thresholds, reasons oral iron is not optimal, prior therapy failures/contraindications, and that the requested dose does not exceed policy limits.

Include diagnosis (e.g., IDA with or without CKD)
Include relevant labs (TSAT, serum ferritin, Hgb)
Confirm oral iron is not optimal per criteria
Confirm requested dose ≤ 1000 mg per infusion

Prior Authorization

Document prior failures to preferred IV iron agents

Submit prior authorization requests that document prior failures to preferred injectable iron agents per indication-specific step requirements (e.g., Ferrlecit and iron sucrose [Venofer] for IDA with CKD; two of Ferrlecit, Infed, or iron sucrose [Venofer] for IDA without CKD). Include documentation if generic Feraheme was tried when required by the step sequence.

For IDA with CKD: failure of Ferrlecit and iron sucrose (Venofer) unless adverse effects/contraindicated
For IDA without CKD: failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless adverse effects/contraindicated
If prior failures met, document failure of generic Feraheme unless contraindicated

Documentation Required

Submit office notes, labs, and clinical records

Providers must submit supporting clinical documentation with the PA request—office chart notes, laboratory results, or other clinical information—to show the member meets all applicable approval criteria.

Office/clinic notes documenting diagnosis and treatment history
Recent lab results demonstrating TSAT, serum ferritin, and/or Hgb values per indication
Documentation of reasons oral iron is not optimal or intolerance

Billing Rule

Provide dosing rationale and coding

Authorization requests should reference dosing rationale and include weight-based dosing details: adults ≥50 kg = 1,000 mg IV single dose; <50 kg = 20 mg/kg IV single dose. Include the appropriate HCPCS code (J1437) for billing.

State patient weight and calculated dose rationale
Confirm requested dose does not exceed 1,000 mg per infusion
Include HCPCS code J1437 for ferric derisomaltose billing

Denial Risk

Incomplete requests may be denied or returned

Requests lacking the required supporting documentation (chart notes, labs, or other clinical information) that the member meets approval criteria may be denied or returned for more information.

Incomplete clinical history or missing labs risks denial
Missing documentation of prior therapy failures or contraindications may lead to denial

Denial Risk

Contraindication (serious hypersensitivity) may trigger denial

Do not request authorization for members with a history of serious hypersensitivity to Monoferric or any of its components; such requests may be denied as contraindicated.

Serious hypersensitivity to Monoferric or components is a listed contraindication
Requests for contraindicated patients are medically not appropriate and may be denied

Site of Care

Note

No explicit site-of-care restriction noted

The policy does not impose explicit site-of-care restrictions in this section; infusion center administration is permitted and no specific site limitations are specified here.

No explicit site-of-care restrictions are stated in this portion of the policy

Note

Administration setting guidance referenced elsewhere

IV infusion administration and covered settings (e.g., home, infusion center, outpatient) are addressed elsewhere in the policy; follow site-of-care guidance in the broader policy for billing and setting-specific requirements.

Refer to the Dosage and Administration and site-of-care sections elsewhere in the policy for setting-specific guidance

Background

Ferric derisomaltose (Monoferric) is an intravenous iron replacement product indicated for treatment of iron deficiency anemia (IDA) in adults who are intolerant of or unresponsive to oral iron and for anemia in non‑hemodialysis dependent chronic kidney disease (NDD‑CKD); the policy also allows certain off‑label use for cancer‑ and chemotherapy‑induced anemia when criteria are met. Dosing guidance referenced in the policy includes weight‑based regimens: adults ≥50 kg may receive 1,000 mg IV as a single dose (repeat dosing permitted if IDA recurs), and adults <50 kg are dosed at 20 mg/kg IV as a single dose. Product is available in single‑dose vials of 1,000 mg/10 mL, 500 mg/5 mL, and 100 mg/mL.

Definitions

IDA definition — iron deficiency anemia

Definition of IDAIDA = iron deficiency anemia

Clinical contextFerric derisomaltose indicated for treatment of iron deficiency anemia in adults intolerant of or unresponsive to oral iron

Policy usePolicy includes IDA associated with CKD and certain off-label uses (cancer/chemotherapy) with laboratory confirmation

CKD definition — chronic kidney disease

CKD abbreviationCKD = chronic kidney disease

NDD-CKD meaningNDD-CKD = non-hemodialysis-dependent chronic kidney disease

CKD in coveragePolicy covers IDA in patients with CKD who are non-hemodialysis dependent (NDD-CKD)

Hgb definition — hemoglobin

Hgb abbreviationHgb = hemoglobin

Role in criteriaHgb values are used diagnostically (sex-specific thresholds) and as triggers to consider IV iron (e.g., Hgb < 7 g/dL)

Appendix referenceHgb listed in Appendix A: Abbreviation/Acronym Key

IDA dosing regimen summary — weight-based dosing described

Weight-based dosing for adults ≥50 kg≥ 50 kg: 1,000 mg IV as a single dose; repeat dose if IDA reoccurs

Weight-based dosing for adults <50 kg< 50 kg: 20 mg/kg actual body weight IV as a single dose; repeat dose if IDA reoccurs

Dose ceilingDose does not exceed 1,000 mg elemental iron (10 mL) per infusion/injection

NDD-CKD — non-hemodialysis-dependent chronic kidney disease

NDD-CKD termNDD-CKD = non-hemodialysis-dependent chronic kidney disease

Coverage implicationPolicy specifically addresses use in NDD-CKD as an FDA-indicated population

Dosing contextDosing recommendations for IDA apply to NDD-CKD patients as described in dosing section

TSAT — transferrin saturation definition

TSAT definitionTSAT = transferrin saturation

Use in criteriaTSAT thresholds (≤30%, <20%, <12%) are used to confirm iron deficiency or to indicate oral iron is not optimal

Most actionable TSAT thresholdTSAT < 12% cited as a reason oral iron is not optimal — important for escalation to IV therapy

Policy Summary

PayerCentene

PolicyFerric Derisomaltose (Monoferric)

Policy CodePolicy CP.PHAR.480

Change TypeNo material changes

Effective DateJun 1, 2020

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets clinical criteria and required prior therapy trials or contraindications.

SourceLink

On This Page

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 (IL HB 5395).

IDA without CKD initial: 5. Dose does not exceed 1,000 mg elemental iron (10 mL) per infusion/injection.dose ≤1000 mg

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 (IL HB 5395).

Cancer/Chemotherapy-induced anemia initial: 5. Dose must be within FDA maximum for any FDA‑approved indication or supported by practice guidelines/peer‑reviewed literature for the off‑label use; prescriber must submit supporting evidence and the regimen must be FDA‑approved or NCCN‑recommended.

Cancer/Chemotherapy-induced anemia approval duration: Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to the member's renewal date, whichever is longer.

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 (IL HB 5395).

Non-CKD continuation: 5. If request is for a dose increase, the new dose does not exceed 1,000 mg elemental iron per infusion/injection.dose ≤1000 mg

Coding/billing: include NDC or HCPCS/CPT codes used for billing and ensure dosing matches billed units.