CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Monoferric (ferric derisomaltose) NON-HEMATOLOGY CRITERIA (Intravenous)

Policy governing coverage and authorization criteria for intravenous Monoferric (ferric derisomaltose) for adults with iron deficiency anemia, including non-dialysis-dependent chronic kidney disease (NDD-CKD); applies to Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMonoferric (ferric derisomaltose) NON-HEMATOLOGY CRITERIA (Intravenous)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date10/01/2021

Next Review Date04/30/2025

Key ActionObtain and document laboratory values within 28 days prior to administration and confirm hemoglobin, ferritin, and TSAT meet criteria before submitting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J1437HCPCS billing code

18+Minimum patient age

35 daysLength of authorization

100Max billable units/35 days

eGFR 15-59Renal function range

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Coverage and Medical Necessity Criteria

Initial Approval Criteria — NDD-CKD

Covered when ALL of the following are met

Age: Member must be 18 years or older

Universal lab and safety criteria: Laboratory values obtained within 28 days prior to administration; other causes of anemia have been ruled out (e.g., blood loss, vitamin deficiency); no history of allergic reaction to any intravenous iron product; discontinue other supplemental iron prior to administrationLabs within 28 days

Indication-specific (NDD-CKD): Member must not be receiving hemodialysis; member has had failure, contraindication, or ineffective response to Injectafer or Feraheme; chronic renal impairment with eGFR 15-59 mL/min; Hemoglobin (Hb) ≤ 11 g/dL; and either ferritin ≤ 100 ng/mL OR ferritin ≤ 300 ng/mL when transferrin saturation (TSAT) ≤ 30%eGFR 15-59 mL/min; Hb ≤ 11 g/dL; Ferritin ≤100 ng/mL OR Ferritin ≤300 ng/mL when TSAT ≤30%

FDA-approved indication

For the NDD-CKD indication, coverage excludes members who are receiving hemodialysis. The member must not be receiving hemodialysis to meet the NDD-CKD criteria for ferric derisomaltose.

Prior to administration, laboratory values must be obtained within 28 days of the anticipated date of infusion. Additionally, other causes of anemia (for example, ongoing blood loss or vitamin deficiencies) must be ruled out before therapy is considered. If required labs are not available within 28 days or alternative causes of anemia have not been excluded, use is not supported.

Billing and Diagnosis Codes

HCPCS coveredHCPCSCovered

J1437

Injection, ferric derisomaltose, 10 mg; 1 billable unit=10 mg

NDCNDC

49442-9301-xx	Monoferric 100 mg /1 mL single-use vial
49442-9305-xx	Monoferric 500 mg /5 mL single-use vial
49442-9310-xx	Monoferric 1000 mg /10 mL single-use vial

Covered ICD-10 Diagnosis CodesICD-10Covered

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
D63.1	Anemia in chronic kidney disease
D63.8	Anemia in other chronic disease classified elsewhere

inv-07: Hemoglobin — threshold value (≤ 11 g/dL)

Hemoglobin threshold≤ 11 g/dL

ContextRequired for NDD-CKD indication (iron‑deficiency anemia) as part of initial approval criteria

Documentation timingHemoglobin value must be obtained within 28 days prior to administration

inv-08: Ferritin — threshold (≤ 100 ng/mL OR ≤300 ng/mL when TSAT ≤30%)

Ferritin threshold≤ 100 ng/mL

Alternate ferritin threshold≤ 300 ng/mL when transferrin saturation (TSAT) ≤ 30%

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for ferric derisomaltose for members age 18 and older. For Medicare members who have previously received this medication within the past 365 days, the Step Therapy requirement does not apply (they are not subject to step therapy).

Applies to members ≥ 18 years

Step Therapy

Step Therapy Requirement and Medicare Exception

Step therapy: prior authorization will only be approved when the member has had failure, contraindication, or an ineffective response to one of the specified IV iron products (Injectafer or Feraheme). Medicare exception: Medicare members with prior receipt of this medication within the past 365 days are exempt from the step therapy requirement.

Step requirement: Failure/contraindication/ineffective response to Injectafer or Feraheme required
Medicare exception: prior receipt within 365 days exempt from step therapy

Background

Monoferric (ferric derisomaltose) is an intravenous iron replacement indicated for adults with iron deficiency anemia, including the FDA‑approved NDD‑CKD population. For NDD‑CKD, patients must meet renal function and laboratory thresholds (eGFR 15–59 mL/min, Hemoglobin ≤ 11 g/dL, and ferritin ≤ 100 ng/mL or ferritin ≤ 300 ng/mL when TSAT ≤ 30%), and must not be receiving hemodialysis. Universal safety requirements include obtaining laboratory values within 28 days, ruling out other causes of anemia, ensuring no history of allergic reaction to IV iron, and discontinuing other supplemental iron prior to administration.

Definitions

inv-15: NDD-CKD (Non-dialysis-dependent chronic kidney disease) — definition and eGFR range requirement (must not be receiving hemodialysis)

DefinitionNon‑dialysis‑dependent chronic kidney disease (NDD‑CKD): chronic renal impairment not receiving hemodialysis

eGFR requirementeGFR between 15–59 mL/min is specified for the covered NDD‑CKD indication

ExclusionMembers receiving hemodialysis are excluded from the NDD‑CKD indication