FDA-approved, for example:

• Diabetes mellitus (Admelog, Afrezza, Basaglar, Basaglar Tempo, Fiasp, Humalog Tempo, Humulin N,  Lyumjev, Lyumjev Tempo)
• Heart failure (Inpefa) 
• Type 1 diabetes mellitus, Stage 2 (Tzield)
• Type 2 diabetes mellitus (Adlyxin, alogliptin, alogliptin/metformin, alogliptin/pioglitazone, Bydureon Bcise, glimepiride/pioglitazone, Glyxambi, metformin extended-release, gastric tablet (generic for Glumetza), metformin extended-release, osmotic tablet (generic for Fortamet), metformin immediate-release 625 mg tablet, metformin immediate-release solution, miglitol, Mounjaro, Ozempic, Qtern, repaglinide/metformin, Riomet ER, Rybelsus, Segluromet, Soliqua, Steglatro, Steglujan, Trijardy XR, Xultophy)
• Type 2 diabetes mellitus and chronic kidney disease (Inpefa)

non-FDA approved, for example:

• Gestational diabetes (metformin extended-release, gastric tablet (generic for Glumetza), metformin extended-release, osmotic tablet (generic for Fortamet), metformin immediate-release solution, Riomet ER)
• Obesity (Bydureon Bcise, Mounjaro, Ozempic, Rybelsus)
• Oligomenorrhea related to polycystic ovarian syndrome (PCOS) (metformin extended-release, gastric tablet [generic for Glumetza], metformin extended-release, osmotic tablet [generic for Fortamet], metformin immediate-release solution, Riomet ER)
• Overweight (Bydureon Bcise, Mounjaro, Ozempic, Rybelsus)
• Prediabetes (Adlyxin, Bydureon Bcise, metformin extended-release, gastric tablet [generic for Glumetza], metformin extended-release, osmotic tablet [generic for Fortamet], metformin immediate-release solution, Ozempic, Riomet ER, Rybelsus)
• Prevention of diabetes related to PCOS (metformin extended-release, gastric tablet [generic for Glumetza], metformin extended-release, osmotic tablet [generic for Fortamet], metformin immediate-release solution, Riomet ER)

Note: The above lists may not include all FDA-approved and non-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.

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

• Documentation of the following is required:
  • appropriate diagnosis of prediabetes, diabetes mellitus, or type 2 diabetes mellitus; and
  • one of the following:
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with Byetta, Trulicity, or Victoza; or
    • adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to Byetta, Trulicity, or Victoza; or
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Byetta, Trulicity, or Victoza; or
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Byetta, Trulicity, and Victoza; and
  • one of the following:
    • requested daily dose does not exceed quantity limits; or
    • clinical rationale for exceeding FDA-approved dosing; and
  • for Mounjaro, the requested agent will not be used in combination with a GLP-1 receptor agonist.
  • please note for the quantity limits listed above:
    • a 28 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 carton of four prefilled pens (Mounjaro)
      • one prefilled pen (Ozempic)
      • one tablet per day (Rybelsus)
    • a 30 day supply should consist of:
      • 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 Byetta, Trulicity, or Victoza for at least 90 days within the last 120-day time period.^†

Admelog

• Documentation of the following is required:
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction to one of the following: Apidra, insulin aspart, insulin lispro.

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 instead of an injectable or prefilled insulin syringe.

alogliptin

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with Januvia, saxagliptin, or Tradjenta; or
    • adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to Januvia, saxagliptin, or Tradjenta; or
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Januvia, saxagiptin, or Tradjenta; or
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Januvia, saxagliptin, and Tradjenta; and
  • one of the following:
    • requested quantity is ≤ one tablet/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, saxagliptin, or Tradjenta for at least 90 days within the last 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 ≥ 90 days of therapy 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 ≥ 90 days of therapy within a 120-day time period) to at least one of the non-metformin agents in the requested combination; or
    • inadequate response (defined as ≥ 90 days of therapy 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
  • for Trijardy XR, medical necessity for use of the combination product instead of the commercially available separate agents.

Basaglar and Basaglar Tempo

• Documentation of the following is required:
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction to insulin glargine prefilled syringe or vial (branded or unbranded Lantus solostar or Lantus vial); and
  • inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction to one of the following: insulin glargine-yfgn prefilled syringe or vial, Rezvoglar prefilled syringe; and
  • for Basaglar Tempo, medical necessity for use of Tempo pen formulation instead of Kwikpen formulation.

Byetta, Trulicity and Victoza exceeding quantity limits

• Documentation of the following is required:
  • appropriate diagnosis: and
  • clinical rationale for exceeding FDA-approved dosing.

Bydureon Bcise, Mounjaro, Ozempic, Rybelsus

• Documentation of the following is required for diagnosis of obesity or overweight:
  • appropriate diagnosis; and
  • one of the following:
    • for Ozempic, Mounjaro, and Rybelsus, member is ≥18 years of age; or
    • for Bydureon Bcise, member is ≥ 12 years of age; and
  • member weight (dated within the last 90 days); and
  • member will continue reduced-calorie diet and increased physical activity; and
  • if requested quantity exceeds quantity limits, clinical rationale for exceeding FDA-approved dosing; and
  • the requested agent will not be used in combination with another GLP-1 receptor agonist; and
  • for Mounjaro, inadequate response or adverse reaction to one or contraindication to both of the following: Saxenda and Wegovy; and
  • one of the following:
    • member BMI is ≥30 kg/m2 (dated within the last 90 days); or
    • for Bydureon Bcise, both of the following:
      • member is ≥12 years of age and <17 years of age; and
      • BMI is in the 95th percentile or greater (dated within the last 90 days); or
    • both of the following:
      • member BMI is ≥27 kg/m2 (dated within the last 90 days); and
      • one of the following weight-related comorbid conditions:
        • coronary heart disease or other atherosclerotic disease; or
        • dyslipidemia; or
        • hypertension; or
        • non-alcoholic steatohepatitis (NASH); or
        • obstructive sleep apnea; or
        • systemic osteoarthritis; or
        • type 2 diabetes mellitus.

• For recertification, documentation of the following is required:
  • member weight (dated within the last 90 days); and
  • one of the following:
    • weight loss of ≥ 5% from baseline body weight; or
    • both of the following:
      • improvement in secondary measures; and
      • clinical rationale for continuation of therapy.

Fiasp, Lyumjev, and Lyumjev Tempo

• 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 (defined as ≥  90 days of therapy within a 180-day time period) or adverse reaction to one of the following: Apidra, insulin aspart, insulin lispro; and
  • for Lyumjev Tempo, medical necessity for use of Tempo pen formulation instead of Kwikpen formulation.

Humalog 100 units/mL prefilled syringe, Humalog 100 units/mL vial, Humalog 75/25 prefilled syringe, Novolog, and Novolog 70/30

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical records documenting an inadequate response or adverse reaction to the therapeutically equivalent generic formulation.

Humalog Tempo

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical necessity for use of Tempo pen formulation instead of Kwikpen formulation.

Humulin N

• Documentation of the following is required:
  • appropriate diagnosis: and
  • inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction to Novolin N prefilled syringe or vial.

Inpefa

• Documentation of the following is required for heart failure:
  • indication of reduction of risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit; and
  • member is ≥ 18 years of age; and
  • inadequate response, adverse reaction, or contraindication to both dapagliflozin and Jardiance; and 
  • requested quantity is ≤ one tablet/day.

• Documentation of the following is required for type 2 diabetes and chronic kidney disease:
  • indication of reduction of risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in type 2 diabetes mellitus and chronic kidney disease with other cardiovascular risk factors; and
  • member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: dapagliflozin, Invokana, Jardiance; and
  • requested quantity is ≤ one tablet/day.

metformin extended-release, gastric tablet (generic Glumetza) and metformin extended-release, osmotic tablet (generic Fortamet)

• Documentation of the following is required for type 2 diabetes, prediabetes, or prevention of diabetes related to PCOS:
  • appropriate diagnosis; and
  • medical records documenting an inadequate response (defined as ≥ 90 days of therapy) or adverse reaction, at the requested dose, to the metformin extended-release, XR tablet formulation available without PA; and
  • for metformin extended-release, gastric tablet, medical necessity for the use of requested product instead of metformin formulations available without PA.

• Documentation of the following is required for gestational diabetes:
  • appropriate diagnosis; and
  • medical records documenting an inadequate response (defined as ≥ 90 days of therapy) or adverse reaction, at the requested dose, to the metformin extended-release, XR tablet formulation available without PA; and
  • for metformin extended-release, gastric tablet, medical necessity for the use of requested product instead of metformin formulations available without PA; and
  • inadequate response, adverse reaction, or contraindication to insulin therapy.

• Documentation of the following is required for oligomenorrhea related to PCOS:
  • appropriate diagnosis; and
  • medical records documenting an inadequate response (defined as ≥ 90 days of therapy) or adverse reaction, at the requested dose, to the metformin extended-release, XR tablet formulation available without PA; and
  • for metformin extended-release, gastric tablet, medical necessity for the use of requested product instead of metformin formulations available without PA; and
  • inadequate response, adverse reaction, or contraindication to combined oral contraceptives.

metformin immediate-release 625 mg tablet 

• Documentation of the following is required:
  • appropriate diagnosis; and
  • medical necessity for the requested formulation instead of metformin tablets available without prior authorization. 

metformin immediate-release solution ≥ 13 years of age and Riomet ER

• Documentation of the following is required for type 2 diabetes, prediabetes, or prevention of diabetes related to PCOS:
  • appropriate diagnosis; and
  • one of the following:
    • medical necessity for the use of a liquid formulation; or
    • medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin tablet formulation, or allergic reaction or adverse reaction to the metformin tablet formulation that is not class specific (i.e., nausea, diarrhea); and
  • for Riomet ER, medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin immediate-release solution formulation.

• Documentation of the following is required for gestational diabetes:
  • appropriate diagnosis; and
  • one of the following:
    • medical necessity for the use of a liquid formulation; or
    • medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin tablet formulation, or allergic reaction or adverse reaction to the metformin tablet formulation that is not class specific (i.e., nausea, diarrhea); and
  • for Riomet ER, medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin immediate-release solution formulation; and
  • inadequate response, adverse reaction, or contraindication to insulin therapy.

• Documentation of the following is required for oligomenorrhea related to PCOS:
  • appropriate diagnosis; and
  • one of the following:
    • medical necessity for the use of a liquid formulation; or
    • medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin tablet formulation, or allergic reaction or adverse reaction to the metformin tablet formulation that is not class specific (i.e., nausea, diarrhea); and
  • for Riomet ER, medical records documenting an inadequate response (defined as ≥ 90 days of therapy) to metformin immediate-release solution formulation; and
  • inadequate response, adverse reaction, or contraindication to combined oral contraceptives.

miglitol

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with acarbose; or
    • adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to acarbose; or
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to acarbose; or
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to acarbose; and
  • one of the following:
    • requested quantity is ≤ three tablets/day; or
    • clinical rationale for exceeding FDA-approved dosing.

SmartPA: Claims for miglitol 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 acarbose for at least 90 days within the last 120-day time period.^†

Rezvoglar and Semglee

• Documentation of the following is required:
  • appropriate diagnosis; and
  • inadequate response (defined as ≥ 90 days of therapy within a 180-day time period) or adverse reaction with insulin glargine prefilled syringe or vial (branded or unbranded Lantus solostar or Lantus vial).

Steglatro

• Documentation of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin used in combination with dapagliflozin, Invokana, or Jardiance; or
    • adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to dapagliflozin, Invokana, or Jardiance; or
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to dapagliflozin, Invokana, or Jardiance; or
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to dapagliflozin, Invokana, and Jardiance; and
  • one of the following:
    • requested quantity is ≤ one tablet/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 dapagliflozin, Invokana, or Jardiance for at least 90 days within the last 120-day time period.^†

Tzield

• Documentation of the following is required for stage 2 type 1 diabetes mellitus:
  • appropriate diagnosis; and
  • member is ≥ eight years of age; and
  • appropriate dosing; and
  • prescriber is an endocrinologist; and
  • lab results documenting ≥ two islet autoantibodies; and
  • one of the following within the last three months:
    • fasting plasma glucose (FPG): 100 to 125 mg/dL; or
    • 2-hour plasma glucose (2-h PG): 140 to 199 mg/dL; and
  • member has not been previously treated with Tzield.

^†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.