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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 – Alpha-Glucosidase Inhibitors

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

acarbose Precose test   #
miglitol Glyset test   #

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 patients 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 patients with moderate-to-severe hepatic impairment.

Sulfonylureas:

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

Thiazolidinediones:

  • Use with caution in patients with edema.
  • Contraindicated in patients with NYHA class III or IV cardiac status.
  • Not recommended for patients 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 – Biguanides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

metformin Glucophage test   #
metformin extended-release solution Riomet ER PA  
metformin extended-release-Fortamet Fortamet PA  
metformin extended-release-Glucophage XR Glucophage XR test   #
metformin extended-release-Glumetza Glumetza PA   BP
metformin solution Riomet PA   - ≥ 13 years #

 Antidiabetic Agents – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

alogliptin / metformin Kazano PA   BP
alogliptin / pioglitazone Oseni PA   BP
canagliflozin / metformin Invokamet test  
canagliflozin / metformin extended-release Invokamet XR test  
dapagliflozin / metformin extended-release Xigduo XR test  
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
glipizide / metformin test  
glyburide / metformin test  
linagliptin / metformin Jentadueto test  
linagliptin / metformin extended-release Jentadueto XR test  
pioglitazone / metformin Actoplus Met test   #
pioglitazone / metformin extended-release Actoplus Met XR test  
repaglinide / metformin PA  
saxagliptin / metformin extended-release Kombiglyze XR test  
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   BP
linagliptin Tradjenta test  
saxagliptin Onglyza test  
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 test  
exenatide Byetta test   BP
exenatide extended-release auto-injection Bydureon Bcise PA  
exenatide extended-release pen Bydureon test  
insulin degludec / liraglutide Xultophy PA  
insulin glargine / lixisenatide Soliqua PA  
liraglutide Victoza test  
lixisenatide Adlyxin PA  
semaglutide injection Ozempic PA  
semaglutide tablet Rybelsus PA  

 Antidiabetic Agents – Insulin

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

insulin aspart 70/30 Novolog test   BP
insulin aspart-Fiasp Fiasp PA  
insulin aspart-Novolog Novolog test   BP
insulin degludec Tresiba test  
insulin detemir Levemir test  
insulin glargine-Basaglar Basaglar PA  
insulin glargine-Lantus Lantus test  
insulin glargine-Semglee Semglee PA  
insulin glargine-Toujeo Toujeo test  
insulin glulisine Apidra test  
insulin human inhalation powder Afrezza PA  
insulin lispro 50/50 Humalog test  
insulin lispro 75/25 Humalog test   BP
insulin lispro-Admelog Admelog PA  
insulin lispro-Humalog Humalog test   BP
insulin lispro-Lyumjev Lyumjev PA  
insulin NPH Humulin N test  
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 Starlix test   #
repaglinide Prandin test   #

 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   BP
pramlintide Symlin 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  
empagliflozin Jardiance test  
ertugliflozin Steglatro PA  

 Antidiabetic Agents – Sulfonylureas - Second Generation

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

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

 Antidiabetic Agents – Thiazolidinediones

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

pioglitazone Actos test   #
rosiglitazone Avandia test  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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.
 

II. Therapeutic Uses

FDA-approved, for example:

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

Note: The above list may not include all 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.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon diagnosis and/or requested medication (see below).

 

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

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response (defined as at least 90 days within a 120-day time period) to metformin used in combination with Bydureon, Byetta, Trulicity, or Victoza; or
      • adverse reaction or contraindication to metformin and inadequate response (defined as at least 90 days within a 120-day time period) to Bydureon, Byetta, Trulicity, or Victoza; or
      • inadequate response (defined as at least 90 days of therapy within a 120-day time period), adverse reaction, or contraindication to metformin and adverse reaction to Bydureon, Byetta, Trulicity, or Victoza; or
      • inadequate response (defined as at least 90 days within a 120-day time period), adverse reaction, or contraindication to metformin and contraindication to Bydureon, Byetta, Trulicity, or Victoza; and
    • one of the following:
      • requested daily dose does not exceed quantity limits; or
      • clinical rationale for exceeding FDA-approved dosing.
    • Please note: a 30 day-supply should consist of: 
      • one carton of two [10-20 µg starter pack or 20 µg maintenance pack] 14 dose pens (Adlyxin)
      • one carton of four 2 mg autoinjectors (Bydureon Bcise)
      • one tablet per day (Rybelsus)
      • two prefilled pens (Ozempic 2 mg/1.5 mL pen) or one prefilled pen (Ozempic 4 mg/3 mL pen)
      • six prefilled pens (Soliqua)
      • one carton of five prefilled pens (Xultophy)

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

 

Admelog

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

 

Afrezza

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

 

alogliptin

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

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

 

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

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

   

Basaglar

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

 

Fiasp and Lyumjev

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


metformin extended-release (generic Fortamet, Glumetza)

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

    

metformin solution ≥ 13 years of age and Riomet ER

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

 

Semglee

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

 

Steglatro

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

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

 

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 05/2003

Last Revised Date: 08/2021


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Last updated 10/25/21

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