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Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & Monoferric®)

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Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & Monoferric®) UnitedHealthcare® Commercial Medical Benefit Drug Policy Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & Monoferric®) Policy Number: 2021D0088F Effective Date: July 1, 2021 Instructions for Use Table of Contents Page Community Plan Policy Coverage Rationale ....................................................................... 1 • Intravenous Iron Replacement Therapy (Feraheme®, Definitions ...................................................................................... 3 Injectafer®, & Monoferric®) Applicable Codes .......................................................................... 3 Background.................................................................................... 4 Benefit Considerations .................................................................. 4 Clinical Evidence ........................................................................... 5 U.S. Food and Drug Administration ............................................. 7 Centers for Medicare and Medicaid Services ............................. 8 References ..................................................................................... 8 Policy History/Revision Information ............................................. 9 Instructions for Use ....................................................................... 9 Coverage Rationale See Benefit Considerations This policy refers to the following intravenous iron replacements: Feraheme® (ferumoxytol) Injectafer® (ferric carboxymaltose) Monoferric® (ferric derisomaltose)* The following intravenous iron replacements are not subject to the coverage criteria in this section: Ferrlecit (sodium ferric gluconate complex) Infed® (iron dextran) Venofer® (iron sucrose) *Medical Necessity Plans Monoferric is not medically necessary for the treatment of any diagnosis addressed within this policy (for Medicare reviews, refer to the CMS section**). Published clinical evidence does not demonstrate superiority in the efficacy and safety of this product to other available intravenous iron replacement products. Feraheme (ferumoxytol), Injectafer (ferric carboxymaltose), and Monoferric (ferric derisomaltose) are proven for the following indications: Iron Deficiency Anemia (IDA) Without Chronic Kidney Disease (CKD) Feraheme and Injectafer are medically necessary when the following criteria are met: For initial therapy, all of the following: o Submission of medical records (e.g., lab values, chart notes, etc.) supporting the diagnosis of IDA; and Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & Monoferric®) Page 1 of 9 UnitedHealthcare Commercial Medical Benefit Drug Policy Effective 07/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. o Patient does not have CKD; and o History of failure, contraindication, or intolerance, to oral iron therapy; and o One of the following: (For Medicare reviews, refer to the CMS section.*) . Both of the following: Submission of laboratory values demonstrating treatment failure after at least 3 weeks of therapy, to at least two of the following intravenous iron therapies each (Note: Laboratory values should be obtained within 1 to 3 weeks following the last dose of intravenous iron in a treatment course): Infed® (iron dextran) Ferrlecit (sodium ferric gluconate complex) Venofer® (iron sucrose) and Physician attests that in their clinical opinion, the clinical response would be expected to be superior with Feraheme or Injectafer than experienced with the other products or . Both of the following: History of intolerance, contraindication, or severe adverse event, to all of the following intravenous iron therapies not previously tried and experienced treatment failure: Infed® (iron dextran) Ferrlecit (sodium ferric gluconate complex) Venofer® (iron sucrose) and Physician attests that in their clinical opinion, the same intolerance, contraindication, or severe adverse event would not be expected to occur with Feraheme or Injectafer than experienced with the other products and o One of the following: . Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; or . Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course and o Initial authorization will be for no longer than 3 months. For continuation of therapy, all of the following: o Coverage has previously been provided by UnitedHealthcare for Feraheme or Injectafer for the treatment of IDA; and o Submission of recent laboratory results (within the past 4 weeks) since the last Feraheme orInjectafer administration to demonstrate need for additional therapy; and o Patient does not have CKD; and o One of the following: . Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; or . Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course and o Continuation authorization will be for no longer than 3 months. Iron Deficiency Anemia (IDA) Associated With Chronic Kidney Disease (CKD), Without End Stage Renal Disease (ESRD) Feraheme and Injectafer are medically necessary when the following criteria are met: For initial therapy, all of the following: o Diagnosis of IDA and CKD; and o Submission of medical records (e.g., lab values, chart notes, etc.) supporting the diagnosis of IDA; and o Patient does not have ESRD; and o One of the following: . Patient’s CKD requires hemodialysis or peritoneal dialysis treatment; or . Both of the following: Patient’s CKD does not require hemodialysis or peritoneal dialysis treatment; and History of failure, contraindication, or intolerance, to oral iron therapy and o One of the following: (for Medicare reviews, refer to the CMS section**) . Both of the following: Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & Monoferric®) Page 2 of 9 UnitedHealthcare Commercial Medical Benefit Drug Policy Effective 07/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. Submission of laboratory values demonstrating treatment failure after at least 3 weeks of therapy, to at least two of the following intravenous iron therapies each (Note: Laboratory values should be obtained within 1 to 3 weeks following the last dose of intravenous iron in a treatment course): Infed® (iron dextran) Ferrlecit (sodium ferric gluconate complex) Venofer® (iron sucrose) and Physician attests that in their clinical opinion, the clinical response would be expected to be superior with Feraheme or Injectafer than experienced with the other products or . Both of the following: History of intolerance, contraindication, or severe adverse event, to all of the following intravenous iron therapies not previously tried and experienced treatment failure: Infed® (iron dextran) Ferrlecit (sodium ferric gluconate complex) Venofer® (iron sucrose) and Physician attests that in their clinical opinion, the same intolerance, contraindication, or severe adverse event would not be expected to occur with Feraheme orInjectafer than experienced with the other products and o One of the following: . Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; or . Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course and o Initial authorization will be for no longer than 3 months. For continuation of therapy, all of the following: o Coverage has previously been provided by UnitedHealthcare for Feraheme or Injectafer for the treatment of IDA with CKD; and o Patient does not have ESRD; and o Submission of recent laboratory results (within the past 4 weeks) since the last Feraheme or Injectafer administration to demonstrate need for additional therapy; and o One of the following: . Feraheme dose does not exceed 510 mg elemental iron per dose and 2.04g elemental iron per course; or . Injectafer dose does not exceed 750 mg elemental iron per dose and 1500mg elemental iron per course and o Continuation authorization will be for no longer than 3 months. Definitions For the purposes of this policy, Iron Deficiency Anemia is defined as: Iron Deficiency Anemia (IDA) Without Chronic Kidney Disease (CKD) or Acute or Chronic Inflammatory Conditions: Serum ferritin <30 ng/mL or transferrin saturation (TSAT) <20% or an absence of stainable iron in bone marrow. 3,4,7,11,18 Iron Deficiency Anemia (IDA) With CKD or Acute or Chronic Inflammatory Conditions: Serum ferritin <100 ng/mL or TSAT <20%. If serum ferritin is 100-300 ng/mL, TSAT <20% is required to confirm iron deficiency.3,4,7,11,18 Applicable Codes The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply. Intravenous Iron Replacement Therapy (Feraheme®, Injectafer®, & Monoferric®) Page 3 of 9 UnitedHealthcare Commercial Medical Benefit Drug Policy Effective 07/01/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. HCPCS Code Description J1437 Injection, ferric derisomaltose, 10 mg J1439 Injection,
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