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Table 26: Antidiabetic Agents


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Drug Category: Endocrine/Metabolic

Medication Class/Individual Agents: Antidiabetic Agents

I. Prior-Authorization Requirements

 Antidiabetic Agents - Anti-CD3 antibodies

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

teplizumab-mzwv Tzield 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.

 

Alpha-glucosidase inhibitors:

  • If hypoglycemia occurs, treat with oral glucose (dextrose) and not cane sugar (sucrose).
  • Contraindications include inflammatory bowel disease, colon ulcerations, and intestinal obstruction.

Biguanides:

  • Hold metformin therapy for 48 hours after receiving iodinated contrast and reinstitute only after confirming normal renal function.
  • May cause lactic acidosis; contraindicated in members predisposed to acidosis (e.g., major surgery, congestive heart failure, hepatic failure).
  • Contraindicated in females and males with renal disease or dysfunction (e.g., serum creatinine greater than or equal to 1.4 mg/dL and 1.5 mg/dL, respectively).

Insulin:

  • Rapid-acting: aspart, glulisine, lispro
    • onset: 15-30 minutes
    • duration: three-five hours
  • Short-acting: regular
    • onset: 30-60 minutes
    • duration: five-eight hours
  • Intermediate-acting: NPH
    • onset: one-three hours
    • duration: 12-16 hours
  • Long-acting: degludec, detemir, glargine
    • onset: one-two hours
    • duration: 20-42 hours

Meglitinides:

  • Take before meals; hold dose if meal is missed.
  • Use with caution in members with moderate-to-severe hepatic impairment.

Sulfonylureas:

  • Use with caution in elderly members and in members with renal or hepatic impairment.

Thiazolidinediones:

  • Use with caution in members with edema.
  • Contraindicated in members with NYHA class III or IV cardiac status.
  • Not recommended for members with abnormal liver function tests.
  • May cause resumption of ovulation and increase risk of pregnancy in premenopausal anovulatory women with insulin resistance.

Pregnancy/lactation:

  • Insulin is the agent of choice during pregnancy and lactation.
 

 Antidiabetic Agents – Alpha-Glucosidase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

acarbose Precose test   # , M90
miglitol PA   M90

 Antidiabetic Agents – Biguanides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

metformin extended-release suspension Riomet ER PA  
metformin extended-release, gastric tablet Glumetza PA   M90
metformin extended-release, osmotic tablet PA   M90
metformin extended-release, XR tablet test   M90
metformin immediate-release 500 mg, 850 mg, 1,000 mg tablet test   M90
metformin immediate-release 625 mg tablet PA   M90
metformin immediate-release solution Riomet PA   - ≥ 13 years # , M90

 Antidiabetic Agents – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

alogliptin / metformin Kazano PA   M90
alogliptin / pioglitazone Oseni PA   M90
canagliflozin / metformin Invokamet test  
canagliflozin / metformin extended-release Invokamet XR test  
dapagliflozin / metformin extended-release Xigduo XR test   BP, M90
dapagliflozin / saxagliptin Qtern PA  
empagliflozin / linagliptin Glyxambi PA  
empagliflozin / linagliptin / metformin extended-release Trijardy XR PA  
empagliflozin / metformin Synjardy test  
empagliflozin / metformin extended-release Synjardy XR test  
ertugliflozin / metformin Segluromet PA  
ertugliflozin / sitagliptin Steglujan PA  
glimepiride / pioglitazone Duetact PA   BP, M90
glipizide / metformin test   M90
glyburide / metformin test   M90
linagliptin / metformin Jentadueto test  
linagliptin / metformin extended-release Jentadueto XR test  
pioglitazone / metformin Actoplus Met test   # , M90
repaglinide / metformin PA   M90
saxagliptin / metformin extended-release Kombiglyze XR test   BP, M90
sitagliptin / metformin Janumet test  
sitagliptin / metformin extended-release Janumet XR test  

 Antidiabetic Agents – Dipeptidyl Peptidase (DPP)-4 Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

alogliptin Nesina PA   M90
linagliptin Tradjenta test  
saxagliptin Onglyza test   BP, M90
sitagliptin Januvia test  

 Antidiabetic Agents – Glucagon Like Peptide (GLP)-1 Agonists and GLP-1 Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

dulaglutide Trulicity PD PA   - > 2 mL/28 days
exenatide 10 mcg injection Byetta PA   - > 2.4 mL/30 days BP
exenatide 5 mcg injection Byetta PA   - > 1.2 mL/30 days BP
exenatide extended-release auto-injection Bydureon Bcise PA  
insulin degludec / liraglutide Xultophy PA  
insulin glargine / lixisenatide Soliqua PA  
liraglutide-Victoza Victoza PA   - >9 mL/30 days BP
semaglutide injection-Ozempic Ozempic PA  
semaglutide tablet Rybelsus PA  

 Antidiabetic Agents – Glucose-Dependent Insulinotropic Polypeptide (GIP) and Glucagon Like Peptide (GLP)-1 Agonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

tirzepatide Mounjaro PA  

 Antidiabetic Agents – Insulin

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

insulin aspart test  
insulin aspart 70/30 test  
insulin aspart 70/30-Novolog Novolog PA  
insulin aspart-Fiasp Fiasp PA  
insulin aspart-Novolog Novolog PA  
insulin degludec Tresiba test   BP
insulin detemir Levemir test  
insulin glargine-aglr Rezvoglar PA  
insulin glargine-Basaglar Basaglar PA  
insulin glargine-Basaglar Basaglar Tempo PA  
insulin glargine-Lantus Lantus PD test   BP
insulin glargine-Toujeo Toujeo test   BP
insulin glargine-yfgn Semglee PA  
insulin glulisine Apidra test  
insulin human inhalation powder Afrezza PA  
insulin lispro 100 units/mL cartridge Humalog test  
insulin lispro 100 units/mL prefilled syringe, vial test  
insulin lispro 100 units/mL prefilled syringe, vial-Humalog Humalog PA  
insulin lispro 100 units/mL prefilled syringe-Humalog Tempo Humalog Tempo PA  
insulin lispro 200 units/mL Humalog test  
insulin lispro 50/50 Humalog test  
insulin lispro 75/25 prefilled syringe test  
insulin lispro 75/25 prefilled syringe-Humalog Humalog PA  
insulin lispro 75/25 vial Humalog test  
insulin lispro-aabc Lyumjev PA  
insulin lispro-aabc Lyumjev Tempo PA  
insulin lispro-Admelog Admelog PA  
insulin NPH Humulin N PA  
insulin NPH Novolin N test  
insulin NPH / regular insulin 70/30 Humulin test  
insulin NPH / regular insulin 70/30 Novolin test  
insulin regular Humulin R test  
insulin regular Novolin R test  

 Antidiabetic Agents – Meglitinides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

nateglinide test   M90
repaglinide test   M90

 Antidiabetic Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

bromocriptine 0.8 mg tablet Cycloset test  
colesevelam Welchol test   # , M90
pramlintide Symlinpen test  

 Antidiabetic Agents – Sodium Glucose Cotransporter (SGLT)-2 Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

canagliflozin Invokana test  
dapagliflozin Farxiga test   BP, M90
empagliflozin Jardiance test  
ertugliflozin Steglatro PA  
sotagliflozin Inpefa PA  

 Antidiabetic Agents – Sulfonylureas - Second Generation

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

glimepiride Amaryl test   # , M90
glipizide test   M90
glipizide extended-release Glucotrol XL test   # , M90
glyburide test   M90
glyburide, micronized Glynase test   # , M90

 Antidiabetic Agents – Thiazolidinediones

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

pioglitazone Actos test   # , M90
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA 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.
 
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 
M90 Mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply.
 

II. Therapeutic Uses

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 (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, Victoza)
  • 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, Victoza)
  • Prediabetes (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.

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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.
  • 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.

 

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.

 

Bydureon Bcise, Ozempic, Rybelsus

  • Documentation of the following is required for the diagnosis of prediabetes or type 2 diabetes:
    • 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 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
    • if requested quantity exceeds quantity limits, clinical rationale for exceeding FDA-approved dosing.
  • Documentation of the following is required for diagnosis of obesity or overweight:
    • appropriate diagnosis; and
    • one of the following:
      • for Ozempic 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 has been counseled to 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
    • 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 for the diagnosis of obesity or overweight, 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.
  • Please note for the quantity limits listed above:
    • a 28 day-supply should consist of: 
      • one carton of four 2 mg autoinjectors (Bydureon Bcise)
      • one prefilled pen (Ozempic)
      • one tablet per day (Rybelsus)

SmartPA: Claims for Bydureon Bcise, Ozempic, and Rybelsus 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.†

 

Byetta and Trulicity exceeding quantity limits

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

 

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, 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.

 

Mounjaro

  • Documentation of the following is required for the diagnosis of type 2 diabetes:
    • 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 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
    • the requested agent will not be used in combination with a GLP-1 receptor agonist; and
    • if requested quantity exceeds quantity limits, clinical rationale for exceeding FDA-approved dosing.
  • Documentation of the following is required for diagnosis of obesity or overweight:
    • appropriate diagnosis; and
    • member is ≥18 years of age; and
    • member weight (dated within the last 90 days); and
    • member has been counseled to continue reduced-calorie diet and increased physical activity; and
    • the requested agent will not be used in combination with another GLP-1 receptor agonist; and
    • one of the following:
      • both of the following:
        • 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; orsystemic osteoarthritis; or
          • type 2 diabetes mellitus; and
        • member BMI is ≥27 kg/m2 (dated within the last 90 days); or
      • member BMI is ≥30 kg/m2 (dated within the last 90 days); and
    • if requested quantity exceeds quantity limits, clinical rationale for exceeding FDA-approved dosing; and
    • one of the following:
      • if the member has received semaglutide, one of the following:
        • inadequate response to Wegovy as defined by all of the following:
          • member is adherent to Wegovy treatment (defined as ≥ 90 days of therapy within a 120-day time period); and
          • member's current BMI is ≥ 27 kg/m2 (dated within the last 90 days); or
        • adverse reaction to semaglutide that cannot be managed or expected as part of GLP-1 receptor agonist therapy; or
      • if the member has not received semaglutide, both of the following:
        • one of the following;
          • inadequate response to liraglutide as defined by all of the following:
            • member is adherent to liraglutide treatment (defined as ≥ 90 days of therapy within a 120-day time period); and
            • no weight loss over at least three months at the highest FDA-approved dose of liraglutide for obesity; and
            • member's current BMI is ≥ 27 kg/m2 (dated within the last 90 days); or
          • adverse reaction to liraglutide that cannot be managed or expected as part of GLP-1 receptor agonist therapy; or
          • contraindication to liraglutide; and
        • one of the following:
          • inadequate response to Wegovy as defined by all of the following:
            • member is adherent to Wegovy treatment (defined as ≥ 90 days of therapy within a 120-day time period); and
            • no weight loss over at least three months at the highest FDA-approved dose of Wegovy for obesity; and
            • member's current BMI is ≥ 27 kg/m2 (dated within the last 90 days); or
          • adverse reaction to semaglutide that cannot be managed or expected as part of GLP-1 receptor agonist therapy.
  • For recertification for the diagnosis of obesity or overweight, 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.
  • Please note for the quantity limits listed above:
    • a 30 day supply should consist of one carton of four prefilled pens.

 

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).

Soliqua and Xultophy

  • 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 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
    • if requested quantity exceeds quantity limits, clinical rationale for exceeding FDA-approved dosing.
    • please note for the quanty limits listed above:
      • a 30 day supply should consist of:
        • six prefilled pens (Soliqua)
        • one carton of five prefilled pens (Xultophy)

SmartPA: Claims for 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.

 

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 or consult notes from specialist are provided; 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; or
      • A1C: 5.7% to 6.4%; or
      • 10% increase in A1C in ≤12 months; and
    • member has not been previously treated with Tzield.

 

Victoza exceeding quantity limits

  • Documentation of the following is required for the diagnosis of type 2 diabetes or prediabetes:
    • appropriate diagnosis; and
    • clinical rationale for exceeding FDA-approved dosing.
  • Documentation of the following is required for the diagnosis of obesity or overweight:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • member is ≥ 12 years of age; and
    • member weight (dated within the last 90 days); and
    • member will be counseled to continue reduced-calorie diet and increased physical activity; and
    • requested quantity is ≤ five pens/30 days; and
    • the requested agent will not be used in combination with another GLP-1 receptor agonist; and
    • one of the following:
      • member BMI is ≥30 kg/m2 (dated within the 90 days prior to treatment initiation); or
      • both of the following:
        • member is ≥12 years of age and <18 years of age; and
        • member BMI is in the 95th percentile or greater (dated within the 90 days prior to treatment initiation); or
      • both of the following:
        • member BMI is ≥27 kg/m2 (dated within the 90 days prior to treatment initiation); 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 for the diagnosis of obesity or overweight, 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.

 

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: 05/2003

Last Revised Date: 05/2024


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Last updated 05/16/24

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