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Table 73: Iron Agents and Chelators


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Drug Category: Iron supplementation and management

Medication Class/Individual Agents: Nutrients and antidotes

I. Prior-Authorization Requirements

 Iron Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

ferric carboxymaltose injection Injectafer PA   MB
ferric citrate Auryxia PA  
ferric derisomaltose Monoferric PA  
ferric maltol Accrufer PA  
ferric pyrophosphate citrate Triferic test   MB
ferrous fumarate test   *, M90
ferrous gluconate test   *, M90
ferrous sulfate test   *, M90
ferumoxytol Feraheme PA  
iron sucrose Venofer test   MB
low molecular weight iron dextran Infed test  
sodium ferric gluconate complex Ferrlecit test   #

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

Intravenous iron replacement therapies1

  • Injectable iron replacement products are iron-carbohydrate complexes consisting of a core made of an iron-oxyhydroxy gel surrounded by a shell of carbohydrate that stabilizes the gel, slows the release of iron, and maintains the resulting particles in colloidal suspension.
  • Current injectable iron replacement formulations differ from each other by chemical structure, adverse event profile, cost and dosing schedule.

 

Parenteral Iron Chelators:

  • Deferoxamine
    • Food and Drug Administration (FDA)-approved for the treatment of acute iron intoxication and chronic iron overload due to transfusion-dependent anemias.
    • Available in vials for intramuscular, subcutaneous, and intravenous administration.
    • Generally requires infusion on at least 5 days per week for at least 8 hours per day.

 

Oral Iron Chelators:

  • Deferasirox
    • Once-daily formulation that was FDA-approved for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older.
  • Deferiprone
    • Approved by the FDA for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate, sickle cell disease, or other anemias.
    • Administered three times daily.

 

1 Auerbach M, Ballard H. Clinical Use of Intravenous Iron: Administration, Efficacy, and Safety. Hematology. 2010 Dec; 1: 338-347.

 

 Iron Chelators

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

deferasirox 125 mg, 250 mg, 500 mg Exjade test   BP, A90
deferasirox 90 mg, 180 mg, 360 mg Jadenu test   # , A90
deferiprone Ferriprox PA   A90
deferoxamine Desferal test   #
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, prior authorization does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for prior authorization requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for prior authorization status and criteria, if applicable.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 
M90 Mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • hyperphosphatemia in chronic kidney disease on dialysis (Auryxia)
  • iron deficiency (Accrufer)
  • iron deficiency anemia (Auryxia, ferumoxytol, Injectafer, Monoferric)
  • transfusional iron overload due to thalassemia syndromes, sickle cell disease, or other anemias (deferiprone)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status may change independently of scheduled MassHealth updates, which may result in additional restrictions.

  

Accrufer

  • Documentation of all of the following is required:
    • diagnosis of iron deficiency; and
    • inadequate response or adverse reaction to two of the following oral iron products: ferrous fumarate, ferrous gluconate, ferrous sulfate or polysaccharide iron complex; and
    • member has attempted strategies to improve tolerability of other iron products if gastrointestinal adverse events occurred.

 

Auryxia

  • Documentation of all of the following is required for a diagnosis of iron deficiency anemia:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction two of the following oral iron products: ferrous fumarate, ferrous gluconate, ferrous sulfate or polysaccharide iron complex; and
    • member has attempted strategies to improve tolerability of other iron products if gastrointestinal adverse events occurred.
  • Documentation of all of the following is required for a diagnosis of hyperphosphatemia in chronic kidney disease on dialysis:
    • appropriate diagnosis.

 

SmartPA: Claims for Auryxia will usually process at the pharmacy without a PA request if the member has a history of medical claims for hyperphosphatemia. 

 

deferiprone

  • Documentation of all of the following is required:
    • one of the following:
      • diagnosis of transfusional iron overload due to thalassemia syndromes; or 
      • diagnosis of transfusional iron overload due to sickle cell disease or other anemia; and
    • member is under the care of an appropriate specialist (hematologist, oncologist); and
    • inadequate response or adverse reaction to one or contraindication to both of the following: deferoxamine, deferasirox; and
    • for the tablet formulation, the member is ≥ eight years of age; and
    • for the oral solution formulation, one of the following:
      • member is ≥ three years to ≤ 13 years of age; or
      • medical necessity for the use of an oral solution formulation.

 

ferumoxytol, Injectafer and Monoferric

  • Documentation of all of the following is required:
    • diagnosis of iron deficiency anemia; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: Infed (low molecular weight iron dextran), sodium ferric gluconate complex, Venofer (iron sucrose).

 

† Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 03/2015

Last Revised Date: 04/2023


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Last updated 04/13/23

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