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.

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.