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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

ferric carboxymaltose injection Injectafer PA  
ferric pyrophosphate citrate Triferic ^ test  
ferrous fumarate * test  
ferrous gluconate * test  
ferrous sulfate * test  
ferumoxytol Feraheme PA  
iron sucrose Venofer PA  
low molecular weight iron dextran Infed PA  
sodium ferric gluconate complex Ferrlecit PA  

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.
    • 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

deferasirox 125 mg, 250 mg, 500 mg Exjade BP test  
deferasirox 90 mg, 180 mg, 360 mg Jadenu test  
deferiprone Ferriprox PA  
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.
 
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example:

  • iron deficiency anemia (Feraheme, Ferrlecit, Infed, Injectafer, Venofer)
  • transfusional iron overload due to thalassemia syndromes (Ferriprox)

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.
  • 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 the member’s condition and requested medication (see below).

 

Feraheme and Injectafer

  • Documentation of all of the following is required:
    • diagnosis of iron deficiency anemia; and
    • one of the following:
      • inadequate response or adverse reaction to one oral iron formulation; or
      • clinical rationale why oral iron therapy cannot be used; and
    • one of the following:
      • inadequate response or adverse reaction to one of the following: Infed (low molecular weight iron dextran), sodium ferric gluconate complex or Venofer (iron sucrose); or
      • contraindication to all of the following: Infed (low molecular weight iron dextran), sodium ferric gluconate complex and Venofer (iron sucrose).

 

Ferriprox

  • Documentation of all of the following is required:
    • diagnosis of thalassemia; and
    • member is ≥ 18 years of age; and
    • member is under the care of an appropriate specialist (hematologist, oncologist).

SmartPA: Claims for Ferriprox will usually process at the pharmacy without a prior authorization request if the member is ≥ 18 years of age, has a history of MassHealth medical claims for thalassemia, and the prescriber is a hematologist or oncologist.†

 

Infed, sodium ferric gluconate complex and Venofer

  • Documentation of all of the following is required:
    • diagnosis of iron deficiency anemia; and
    • one of the following:
      • inadequate response or adverse reaction to one oral iron formulation; or
      • clinical rationale why oral iron therapy cannot be used.

 

† 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: 08/2019


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Last updated 08/29/19