Table 73: Iron Agents and Chelators
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Iron supplementation and management
Medication Class/Individual Agents: Nutrients and antidotes
I. Prior-Authorization Requirements
Iron Agents |
Clinical Notes |
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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
Parenteral Iron Chelators:
Oral Iron Chelators
1 Auerbach M, Ballard H. Clinical Use of Intravenous Iron: Administration, Efficacy, and Safety. Hematology. 2010 Dec; 1: 338-347. |
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Iron Chelators |
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# | 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 (Accrufer)
- iron deficiency anemia (Ferrlecit, ferumoxytol, Infed, Injectafer, Monoferric, Venofer)
- 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.
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).
Accrufer
- Documentation of all of the following is required:
- diagnosis of iron deficiency; and
- inadequate response or adverse reaction to three of the four 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 has been attempted.
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 and deferasirox; and
- if the request is for the tablet formulation the member is ≥ eight years of age; and
- if the request is for the oral solution formulation one of the following:
- member is ≥ three to ≤ 13 years of age; or
- medical necessity for the use of an oral solution formulation.
- one of the following:
ferumoxytol, Injectafer and Monoferric
- 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).
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: 11/2021
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Last updated 05/09/22