FDA-approved, for example:

• Diabetes mellitus (Admelog, Afrezza, Basaglar, Fiasp, Lyumjev)
• Type 2 diabetes mellitus (Adlyxin, alogliptin, alogliptin/metformin, alogliptin/pioglitazone, Bydureon Bcise, glimepiride/pioglitazone, Glyxambi, metformin extended-release (generic Fortamet, Glumetza), Ozempic, Qtern, repaglinide/metformin, Riomet, Riomet ER, Rybelsus, Segluromet, Soliqua, Steglatro, Steglujan, Trijardy XR, Xultophy)

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.
• 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).

Adlyxin, Bydureon Bcise, Ozempic, Rybelsus, Soliqua, and Xultophy

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response (defined as at least 90 days within a 120-day time period) to metformin used in combination with Bydureon, Byetta, Trulicity, or Victoza; or
    • adverse reaction or contraindication to metformin and inadequate response (defined as at least 90 days within a 120-day time period) to Bydureon, Byetta, Trulicity, or Victoza; or
    • inadequate response (defined as at least 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Bydureon, Byetta, Trulicity, or Victoza; or
    • inadequate response (defined as at least 90 days within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Bydureon, Byetta, Trulicity, or Victoza; and
  • one of the following:
    • requested daily dose does not exceed quantity limits; or
    • clinical rationale for exceeding FDA-approved dosing.
  • Please note: a 30 day-supply should consist of: 
    • one carton of two [10-20 µg starter pack or 20 µg maintenance pack] 14 dose pens (Adlyxin)
    • one carton of four 2 mg autoinjectors (Bydureon Bcise)
    • one tablet per day (Rybelsus)
    • two prefilled pens (Ozempic)
    • six prefilled pens (Soliqua)
    • one carton of five prefilled pens (Xultophy)

SmartPA: Claims for Adlyxin, Bydureon Bcise, Ozempic, Rybelsus, Soliqua, and Xultophy within the quantity limit (as described above) will usually process at the pharmacy without a PA request if the member has a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin and Bydureon, Byetta, Trulicity, or Victoza for at least 90 days within a 120-day time period.^†

Admelog

• Documentation of the following is required:
  • appropriate diagnosis; and
  • inadequate response to at least 90 days of therapy (within a six-month time period) or adverse reaction with Apidra (insulin glulisine), insulin lispro, or insulin aspart.

Afrezza

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • medical necessity for the use of an inhaled insulin product over an injectable or prefilled insulin syringe.

alogliptin

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response (defined as at least 90 days within a 120-day time period) to metformin used in combination with Januvia, Onglyza, or Tradjenta; or
    • adverse reaction or contraindication to metformin and inadequate response (defined as at least 90 days within a 120-day time period) to Januvia, Onglyza, or Tradjenta; or
    • inadequate response (defined as at least 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Januvia, Onglyza, or Tradjenta; or
    • inadequate response (defined as at least 90 days within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Januvia, Onglyza, and Tradjenta; and
  • one of the following:
    • requested daily dose does not exceed one tablet per day; or
    • clinical rationale for exceeding FDA-approved dosing.

SmartPA: Claims for alogliptin within the quantity limit (described above) will usually process at the pharmacy without a PA request if the member has a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin and Januvia, Onglyza, or Tradjenta for at least 90 days within a 120-day time period.^†

alogliptin/metformin, alogliptin/pioglitazone, glimepiride/pioglitazone, Glyxambi, Qtern, repaglinide/metformin, Segluromet, Steglujan, and Trijardy XR

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response (defined as at least 90 days within a 120-day time period) to combination therapy with metformin used in combination with at least one of the non-metformin agents in the requested combination; or
    • adverse reaction or contraindication to metformin and inadequate response (defined as at least 90 days within a 120-day time period) to at least one of the non-metformin agents in the requested combination; or
    • inadequate response (defined as at least 90 days within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to at least one of the non-metformin agents in the requested combination; and
  • if the request is for Trijardy XR, clinical rationale for use of the combination product instead of the commercially available separate agents.

Basaglar

• Documentation of the following is required:
  • appropriate diagnosis; and
  • inadequate response to at least 90 days (within a six-month time period) or adverse reaction with Lantus (insulin glargine) prefilled syringe.

Fiasp and Lyumjev

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • for Fiasp, member is ≥ two years of age; or
    • for Lyumjev, member is ≥ 18 years of age; and
  • inadequate response to at least 90 days (within a six-month time period) or adverse reaction with Apidra (insulin glulisine), insulin lispro, or insulin aspart.

metformin extended-release (generic Fortamet, Glumetza)

• Documentation of the following is required:
  • appropriate diagnosis; and
  • medical records documenting an inadequate response or adverse reaction despite 90 days of therapy with a generic extended-release metformin formulation at the requested dose that is AB-rated to Glucophage XR; and
  • if the request is for metformin extended-release (generic Glumetza), the member must meet the above criteria and prescriber must provide clinical rationale for the use of this product instead of other available metformin formulations.

metformin solution ≥ 13 years of age and Riomet ER

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • medical necessity for the use of a liquid formulation; or
    • medical records documenting an inadequate response to at least 90 days of therapy with the metformin tablet formulation, or allergic reaction or adverse reaction to the metformin tablet formulation that is not class specific (i.e., nausea, diarrhea); and
  • if the request is for Riomet ER, the member must meet the above criteria and prescriber must provide medical records documenting an inadequate response to at least 90 days of therapy with the immediate release metformin solution formulation.

Semglee

• Documentation of the following is required:
  • appropriate diagnosis; and
  • an inadequate response to at least 90 days of therapy (within a six-month time period) or adverse reaction with Lantus Solostar (insulin glargine) prefilled syringe or Lantus (insulin glargine) vial.

Steglatro

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response (defined as at least 90 days within a 120-day time period) to metformin used in combination with Farxiga, Invokana, or Jardiance; or
    • adverse reaction or contraindication to metformin and inadequate response (defined as at least 90 days within a 120-day time period) to Farxiga, Invokana, or Jardiance; or
    • inadequate response (defined as at least 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Farxiga, Invokana, or Jardiance; or
    • inadequate response (defined as at least 90 days within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Farxiga, Invokana, or Jardiance; and
  • one of the following:
    • requested daily dose does not exceed one tablet per day; or
    • clinical rationale for exceeding FDA-approved dosing.

SmartPA: Claims for Steglatro within the quantity limit (described above) will usually process at the pharmacy without a PA request if the member has a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin and Farxiga, Invokana, or Jardiance for at least 90 days within a 120-day time period.^†

^†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.