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Drug Category: Endocrine/Metabolic

Medication Class/Individual Agents: Oral Antidiabetic Agents

I. Prior-Authorization Requirements

 Antidiabetic Agents: Oral – Alpha-Glucosidase Inhibitors

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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).

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: Oral – Biguanides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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

 Antidiabetic Agents: Oral – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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

 Antidiabetic Agents: Oral – Dipeptidyl Peptidase (DPP)-4 Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

alogliptin Nesina PA  
linagliptin Tradjenta test  
saxagliptin Onglyza test  
sitagliptin Januvia test  

 Antidiabetic Agents: Oral – Meglitinides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

nateglinide Starlix # test  
repaglinide Prandin # test  

 Antidiabetic Agents: Oral – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

bromocriptine 0.8 mg tablet Cycloset PA  
colesevelam Welchol BP test  

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

canagliflozin Invokana test  
dapagliflozin Farxiga test  
empagliflozin Jardiance test  
ertugliflozin Steglatro PA  

 Antidiabetic Agents: Oral – Sulfonylureas - First Generation

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

chlorpropamide test  
tolazamide test  
tolbutamide test  

 Antidiabetic Agents: Oral – Sulfonylureas - Second Generation

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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

 Antidiabetic Agents: Oral – Thiazolidinediones

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

pioglitazone Actos # test  
rosiglitazone Avandia PA  
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.
 

II. Therapeutic Uses

FDA-approved, for example:

  •  type-2 diabetes mellitus

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).

   

Actoplus Met XR and pioglitazone/metformin

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • inadequate response to 90 days of therapy (within a six-month time period) with metformin; and
    • if the request is for Actoplus Met XR, the member must meet the above criteria and prescriber must provide medical records documenting an inadequate response to immediate-release pioglitazone/metformin.
SmartPA: Claims for pioglitazone/metformin will usually process and pay at the pharmacy if the member has a history of paid MassHealth pharmacy claims for the requested agent for the last 90/120 days or there is a history of type 2 diabetes and paid MassHealth pharmacy claims for metformin for a total of 90 days within a 120-day time period.

     

alogliptin, alogliptin/pioglitazone, Avandia, Cycloset, glimepiride/pioglitazone, Glyxambi, Qtern, Steglatro, and Steglujan

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response (defined as at least 90 days within a six-month time period) to combination therapy with metformin and one of the following: dipeptidyl peptidase (DPP)-4 inhibitor, exenatide, insulin therapy, pioglitazone, sodium glucose cotransporter (SGLT)-2 inhibitor, sulfonylurea; or
      • adverse reaction or contraindication to metformin and inadequate response (defined as at least 90 days within a six-month time period) to one of the following: DPP-4 inhibitors, exenatide, insulin therapy, pioglitazone, SGLT-2 inhibitors, sulfonylureas; or
      • inadequate response (defined as at least 90 days within a six-month time period), adverse reaction, or contraindication to metformin and adverse reaction to one of the following: DPP-4 inhibitors, exenatide, insulin therapy, pioglitazone, SGLT-2 inhibitors, sulfonylureas; or 
      • inadequate response (defined as at least 90 days within a six-month time period), adverse reaction, or contraindication to metformin and contraindication to all of the following: DPP-4 inhibitors, exenatide, insulin therapy, pioglitazone, SGLT-2 inhibitors, sulfonylureas; and
    • for requests for alogliptin, one of the following:
      • request is within quantity limit of 30 tablets/30 days; or
      • clinical rationale for exceeding FDA-approved dosing.

SmartPA: Claims for alogliptin (within a quantity limit of 30 tablets/30 days), alogliptin/pioglitazone, Avandia, Cycloset, glimepiride/pioglitazone, Glyxambi, Qtern, Steglatro, and Steglujan will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for at least 90 days in the past 120 days of the respective medication or a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin/glyburide, metformin/glipizide, Invokamet, Janumet, Janumet XR, Jentadueto, Kombiglyze XR, pioglitazone/metformin, or Xigduo XR for at least 90 days within a 120-day time period, or a history of paid MassHealth pharmacy claims for metformin and a second less costly antidiabetic agent (insulin, sulfonylurea, pioglitazone, DPP-IV inhibitor, SGLT-2 inhibitor, or exenatide) for at least 90 days of each agent in the last 120 days.

  

alogliptin/metformin, Invokamet XR, Jentadueto XR, repaglinide/metformin, Segluromet, Synjardy, and Synjardy XR

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response to combination therapy with metformin for at least 90 days (within a six-month time period) with one of the following: DPP-4 inhibitor, exenatide, insulin therapy, pioglitazone, SGLT-2 inhibitor, sulfonylurea; or
      • inadequate response to metformin for at least 90 days (within a six-month time period) and an adverse reaction to one of the following or contraindication to all of the following: DPP-4 inhibitors, exenatide, insulin therapy, pioglitazone, SGLT-2 inhibitors, sulfonylurea. 
SmartPA: Claims for alogliptin/metformin, Invokamet XR, Jentadueto XR, repaglinide/metformin, Segluromet, Synjardy, and Synjardy XR will usually process at the pharmacy without a PA request if the member has paid MassHealth pharmacy claims for at least 90 days in the past 120 days of the respective medication or a history of type 2 diabetes mellitus and paid MassHealth pharmacy claims for metformin/glyburide, metformin/glipizide, Invokamet, Janumet, Janumet XR, Jentadueto, Kombiglyze XR, pioglitazone/metformin, or Xigduo XR for at least 90 days within a 120-day time period, or a history of paid MassHealth pharmacy claims for metformin and a second less costly antidiabetic agent (insulin, sulfonylurea, pioglitazone, DPP-IV inhibitor, SGLT-2 inhibitor, or exenatide) for at least 90 days of each agent in the last 120 days.

   

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 over other available metformin formulations.

    

metformin solution ≥ 13 years of age

  • 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 generic metformin tablet formulation, an allergic reaction or adverse reaction to the generic oral tablet that is not class specific (i.e., nausea, diarrhea).

SmartPA: Claims for metformin solution (for members ≥ 13 years of age) will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for at least 90 days in the past 120 days of the respective medication.

     

 

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: 08/2019


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Last updated 08/29/19