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Drug Category: Endocrine/Metabolic

Medication Class/Individual Agents: Antidiabetic Agents - Injectable and Insulin

I. Prior-Authorization Requirements

 Antidiabetic Agents – Inhaled Insulin

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

insulin human inhalation powder Afrezza 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.

Insulin:

  • Rapid-acting: aspart, glulisine, lispro
    • onset: 15-30 minutes
    • duration: 3-5 hours
  • Short-acting: regular
    • onset: 30-60 minutes
    • duration: 5-8 hours
  • Intermediate-acting: NPH
    • onset: 1-3 hours
    • duration: 12-16 hours
  • Long-acting: degludec, detemir, glargine
    • onset: 1-2 hours
    • duration: 20-42 hours
 

 Antidiabetic Agents – Injectable Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

insulin degludec / liraglutide Xultophy PA  
insulin glargine / lixisenatide Soliqua PA  

 Antidiabetic Agents – Injectable Insulin

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

insulin aspart 70/30 Novolog test  
insulin aspart-Fiasp Fiasp PA  
insulin aspart-Novolog Novolog test  
insulin degludec Tresiba test  
insulin detemir Levemir test  
insulin glargine-Basaglar Basaglar PA  
insulin glargine-Lantus Lantus test  
insulin glargine-Toujeo Toujeo test  
insulin glulisine Apidra test  
insulin lispro 50/50 Humalog test  
insulin lispro 75/25 Humalog test  
insulin lispro-Admelog Admelog PA  
insulin lispro-Humalog Humalog BP test  
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 – Injectable Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

albiglutide Tanzeum PA  
dulaglutide Trulicity PA  
exenatide Byetta BP test  
exenatide extended-release auto-injection Bydureon Bcise PA  
exenatide extended-release pen, vial Bydureon test  
liraglutide Victoza PA  
lixisenatide Adlyxin PA  
pramlintide Symlin PA  
semaglutide Ozempic PA  
Table Footnotes
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:

  • Diabetes mellitus (Admelog, Afrezza, Basaglar, Fiasp, Symlin)
  • Type 2 diabetes mellitus (Adlyxin, Bydureon, Ozempic, Soliqua, Tanzeum, Trulicity, Victoza, 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 the member’s condition and requested medication (see below).

 

Adlyxin, Bydureon Bcise, Ozempic, Soliqua, Tanzeum, Trulicity, Victoza, 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 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
    • requested daily dose does not exceed one carton, pen, or box per 30 days.
    • 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)
      • two prefilled pens (Ozempic)
      • six prefilled pens (Soliqua)
      • one carton of four single dose pens (Tanzeum, Trulicity)
      • one carton of two 18 mg prefilled pens (Victoza 18 mg/3 mL 2 pack)
      • one carton of three 18 mg prefilled pens (Victoza 18 mg/3 mL 3 pack)
      • one carton of five prefilled pens (Xultophy)

SmartPA: Claims for Adlyxin, Bydureon Bcise, Ozempic, Soliqua, Tanzeum, Trulicity, Victoza, 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 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.

 

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 Novolog (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.

 

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

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • 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 Novolog (insulin aspart).

 

Symlin

  • Documentation of the following is required:
    • indication for adjunct treatment in member with diabetes mellitus who uses mealtime insulin therapy; and
    • member is ≥ 18 years of age; and
    • inadequate response despite an adequate duration (> 90 days) of mealtime insulin therapy; and 
    • member is not on any medications that stimulate gastrointestinal motility or for the treatment of gastroparesis (e.g., metoclopramide or erythromycin).

  

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: 09/2003

Last Revised Date: 08/2019


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Last updated 11/18/19