Skip to Content

Table 26: Antidiabetic Agents


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: 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.

 

Phentermine Contraindication

The following are acceptable contraindications to phentermine:

  • Allergy to phentermine or any of the excipients
  • Arrhythmia
  • Bipolar disorder with mania
  • Concomitant use of stimulants
  • Congestive heart failure
  • Coronary artery disease
  • Glaucoma
  • History of psychosis
  • History of stroke
  • Hyperthyroidism
  • Substance use disorder (SUD)
  • Uncontrolled anxiety despite pharmacotherapy
  • Uncontrolled hypertension defined as average blood pressure of ≥ 140/90 mm Hg despite pharmacotherapy

 

 

 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 PA  
canagliflozin / metformin extended-release Invokamet XR PA  
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 PA   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 PA   M90
sitagliptin-Januvia Januvia test  
sitagliptin-Zituvio Zituvio PA   M90

 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 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 PA  
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 PA  
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, Invokana, Invokamet, Invokamet XR, metformin extended-release, gastric tablet (generic Glumetza), metformin extended-release, osmotic tablet (generic Fortamet), metformin immediate-release 625 mg tablet, metformin immediate-release solution, miglitol, Mounjaro, Onglyza, Ozempic, Qtern, repaglinide/metformin, Riomet ER, Rybelsus, saxagliptin/metformin extended-release, Segluromet, sitagliptin (generic Zituvio), Soliqua, Steglatro, Steglujan, Trijardy XR, Xultophy)
  • Type 2 diabetes mellitus and chronic kidney disease (Inpefa)
  • Type 2 diabetes mellitus and diabetic nephropathy with albuminuria (Invokana)  

non-FDA-approved, for example:

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

 

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

Back to top


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 and Apidra

  • Documentation of both 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: insulin aspart (Novolog or therapeutically equivalent generic), insulin lispro (Humalog or therapeutically equivalent generic).

 

Afrezza

  • Documentation of all 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 and saxagliptin

  • Documentation of all 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 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 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 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 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 and saxagliptin 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 or Tradjenta for at least 90 days within the last 120-day time period.

 

alogliptin/metformin, alogliptin/pioglitazone, glimepiride/pioglitazone, Glyxambi, Invokamet, Invokamet XR, Qtern, repaglinide/metformin, saxagliptin/metformin extended-release, Segluromet, Steglujan, and Trijardy XR

  • Documentation of all 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 all 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 (i.e., documentation that member has access to the Tempo smart button and accompanying app).

 

Bydureon Bcise, Ozempic, Rybelsus

  • Documentation of all 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, liraglutide (generic Victoza), or Trulicity; or
      • adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to Byetta, liraglutide (generic Victoza), or Trulicity; 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, liraglutide (generic Victoza), or Trulicity; 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, liraglutide (generic Victoza), or Trulicity; and
    • if requested quantity exceeds quantity limits, clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing; and
    • requested agent will not be used in combination with another GLP-1 receptor agonist.

 

  • Documentation of all 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 90 days prior to treatment initiation); and
    • member has been counseled to continue reduced-calorie diet and increased physical activity; and
    • if requested quantity exceeds quantity limits, clinical rationale why dose cannot be consolidated or 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*:
      • inadequate response to phentermine with or without topiramate defined as all of the following: 
        • member is adherent to phentermine (defined as ≥ 90 days out of 120 days)**; and
        • one of the following:
          • insufficient clinical response defined as < 5% reduction in bodyweight from baseline despite initial trial of ≥ three months of treatment with the maximally tolerated dose of phentermine; or
          • plateaued clinical response defined as no weight loss for at least ≥ three months of treatment with the maximally tolerated dose of phentermine; and
        • member's current BMI is ≥  27 kg/m2; or
      • medical records documenting adverse reaction to phentermine that is allergic in nature or cannot be expected or managed as part of weight loss therapy; or
      • medical records documenting contraindication to phentermine; and
    • one of the following:
      • member BMI is ≥ 30 kg/m2 (dated within the 90 days prior to treatment initiation); 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 90 days prior to treatment initiation); 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
          • polycystic ovarian syndrome; or
          • prediabetes; or
          • systemic osteoarthritis; or
          • type 2 diabetes mellitus.
  • For recertification for the diagnosis of obesity or overweight, documentation of all 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
        • attestation that the improvement in secondary measure is believed to be related to anti-obesity therapy despite lack of reduction in body weight.
  • 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)

 

*Please note, members who have paid MassHealth pharmacy claims for a GLP-1 agonist within the last 90 days may bypass the phentermine trial. For all other members, documentation of clinical rationale why the member is not new to GLP-1 therapy is required to bypass the phentermine trial.

**Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.

 

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, liraglutide (generic Victoza), or Trulicity for at least 90 days within the last 120-day time period.

 

Byetta and Trulicity exceeding quantity limits

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing; and
    • requested agent will not be used in combination with another GLP-1 receptor agonist.

 

Fiasp, Lyumjev, and Lyumjev Tempo

  • Documentation of all 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 ≥ one 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: insulin aspart (Novolog or therapeutically equivalent generic), insulin lispro (Humalog or therapeutically equivalent generic); and
    • for Lyumjev Tempo, medical necessity for use of Tempo pen formulation instead of Kwikpen formulation (i.e., documentation that member has access to the Tempo smart button and accompanying app).

 

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

  • Documentation of both 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 both of the following is required:
    • appropriate diagnosis; and
    • medical necessity for use of Tempo pen formulation instead of Kwikpen formulation (i.e., documentation that member has access to the Tempo smart button and accompanying app).

 

Humulin N

  • Documentation of both 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 all 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 all 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.

 

Invokana

  • Documentation of all of the following is required for the diagnosis of diabetic nephropathy with albuminuria:
    • indication of risk reduction of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ one tablet/day.
  • Documentation of all 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 dapagliflozin 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 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 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 and Jardiance; and
    • one of the following:
      • requested quantity is ≤ one tablet/day; or
      • clinical rationale for exceeding FDA-approved dosing.

SmartPA: Claims for Invokana 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 or Jardiance for at least 90 days within the last 120-day time period.

 

liraglutide (generic Victoza) exceeding quantity limits

  • Documentation of all of the following is required for the diagnosis of type 2 diabetes or prediabetes:
    • appropriate diagnosis; and
    • clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing; and
    • requested agent will not be used in combination with another GLP-1 receptor agonist.
  •    Documentation of all 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 90 days prior to treatment initiation); 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*:
      • inadequate response to phentermine with or without topiramate defined as all of the following:
        • member is adherent to phentermine (defined as ≥ 90 days out of 120 days)**; and
        • one of the following:
          • insufficient clinical response defined as < 5% reduction in bodyweight from baseline despite initial trial of ≥ three months of treatment with the maximally tolerated dose of phentermine; or
          • plateaued clinical response defined as no weight loss for at least ≥ three months of treatment with the maximally tolerated dose of phentermine; and
        •  member's current BMI is ≥ 27 kg/m2; or
      • medical records documenting adverse reaction to phentermine that is allergic in nature or cannot be expected or managed as part of weight loss therapy; or
      • medical records documenting contraindication to phentermine; 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
          • polycystic ovarian syndrome; or
          • prediabetes; or
          • systemic osteoarthritis; or
          • type 2 diabetes mellitus.
  • For recertification for the diagnosis of obesity or overweight, documentation of all 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
        • attestation that the improvement in secondary measure is believed to be related to anti-obesity therapy despite lack of reduction in body weight.

*Please note, members who have paid MassHealth pharmacy claims for a GLP-1 agonist within the last 90 days may bypass the phentermine trial. For all other members, documentation of clinical rationale why the member is not new to GLP-1 therapy is required to bypass the phentermine trial. 

**Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.

 

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

  • Documentation of all 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 all 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 all 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 both 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 all 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 all 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 all 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 all 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 all 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, liraglutide (generic Victoza), or Trulicity; or
      • adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to Byetta, liraglutide (generic Victoza), or Trulicity; 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, liraglutide (generic Victoza), or Trulicity; 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, liraglutide (generic Victoza), or Trulicity; and
    • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to Ozempic; 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 why dose cannot be consolidated or for exceeding FDA-approved dosing.

 

  • Documentation of all 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 90 days prior to treatment initiation); and
    • member has been counseled to continue reduced-calorie diet and increased physical activity; and
    • medical necessity for the requested agent instead of Zepbound; and
    • the requested agent will not be used in combination with another GLP-1 receptor agonist; and
    • if requested quantity exceeds quantity limits, clinical rationale why dose cannot be consolidated or for exceeding FDA-approved dosing; and
    • one of the following*:
      • inadequate response to phentermine with or without topiramate as defined as all of the following:
        • member is adherent to phentermine (defined as ≥ 90 days out of 120 days)**; and
        • one of the following:
          • insufficient clinical response defined as < 5% reduction in bodyweight from baseline despite initial trial of ≥ three months of treatment with the maximally tolerated dose of phentermine; or
          • plateaued clinical response defined as no weight loss for at least ≥ three months of treatment with the maximally tolerated dose of phentermine; and
        • member's current BMI is ≥ 27 kg/m2 (dated within the 90 days prior to treatment initiation); or
      • medical records documenting adverse reaction to phentermine that is allergic in nature or cannot be expected or managed as part of weight loss therapy; or
      • medical records documenting contraindication to phentermine; and
    • one of the following:
      • member BMI ≥ 30 kg/m2 (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
          • polycystic ovarian syndrome; or
          • prediabetes; or
          • systemic osteoarthritis; or
          • type 2 diabetes mellitus.
  • For recertification for the diagnosis of obesity or overweight, documentation of all 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
        • attestation that the improvement in secondary measure is believed to be related to anti-obesity therapy despite lack of reduction in body weight.
  • Please note for the quantity limits listed above:
    • a 30 day supply should consist of one carton of four prefilled pens.

*Please note, members who have paid MassHealth pharmacy claims for a GLP-1 agonist within the last 90 days may bypass the phentermine trial. For all other members, documentation of clinical rationale why the member is not new to GLP-1 therapy is required to bypass the phentermine trial. 

**Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.

 

Rezvoglar and Semglee

  • Documentation of both 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).

 

sitagliptin (generic Zituvio)

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale for the requested agent instead of Januvia; and
    • one of the following:
      • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to combination therapy of metformin used with each of the following: alogliptin, saxagliptin, Tradjenta; or
      • adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to all of the following: alogliptin, saxagliptin, Tradjenta; or
      • inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to metformin and adverse reaction or contraindication to all of the following: alogliptin, saxagliptin, Tradjenta; and
    • if requested quantity exceeds quantity limits, clinical rationale for exceeding FDA-approved dosing.

 

Soliqua and Xultophy

  • Documentation of all 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, liraglutide (generic Victoza), or Trulicity; or
      • adverse reaction or contraindication to metformin and inadequate response (defined as ≥ 90 days of therapy within a 120-day time period) to Byetta, liraglutide (generic Victoza), or Trulicity; 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, liraglutide (generic Victoza), or Trulicity; 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, liraglutide (generic Victoza), or Trulicity; and
    • if requested quantity exceeds quantity limits, clinical rationale why dose cannot be consolidated or 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, liraglutide (generic Victoza), or Trulicity for at least 90 days within the last 120-day time period.

 

Steglatro

  • Documentation of all 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 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 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 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 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 or Jardiance for at least 90 days within the last 120-day time period.

 

Tzield

  • Documentation of all 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 a specialist are provided; and
    • lab results documenting ≥ two islet autoantibodies; and
    • member has not been previously treated with Tzield; 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
      • both of the following:
        • 10% increase in A1C in ≤12 months; and
        •  A1C is ≤ 6.4%.

 

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: 01/2025


Clinical Criteria Main Page | Back to topPrevious  |  Next

Last updated 01/06/25

Feedback