Diabetic GLP-1's
Indications for Prior Authorization
Byetta (exenatide injection)
-
For diagnosis of Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of use: 1) Byetta is not indicated for use in patients with type 1 diabetes, 2) Byetta contains exenatide and should not be used with other products containing the active ingredient exenatide. 3) Byetta has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
Bydureon BCise (exenatide extended-release)
-
For diagnosis of Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Use: 1) Bydureon BCise is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rat thyroid C-cell tumor findings to humans, 2) Bydureon BCise is not indicated for use in patients with type 1 diabetes mellitus, 3) Bydureon BCise is an extended-release formulation of exenatide and should not be used with other products containing the active ingredient exenatide, 4) Bydureon BCise has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
Mounjaro (tirzepatide)
-
For diagnosis of Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of use: Mounjaro has not been studied in patients with a history of pancreatitis. It is not indicated for use in patients with type 1 diabetes mellitus.
Ozempic (semaglutide)
-
For diagnosis of Type 2 Diabetes Mellitus
Indicated 1) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, 2) to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease, 3) to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
Rybelsus (semaglutide)
-
For diagnosis of Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: RYBELSUS is not indicated for use in patients with type 1 diabetes mellitus.
Trulicity (dulaglutide)
-
For diagnosis of Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus, and is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. Limitations of Use: 1) Trulicity has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis, 2) should not be used in patients with type 1 diabetes mellitus, 3) has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients.
Victoza (liraglutide injection)
-
For diagnosis of Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus, and is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. Limitations of Use: 1) Victoza should not be used in patients with type 1 diabetes mellitus, 2) contains liraglutide and should not be coadministered with other liraglutide-containing products.
Criteria
Bydureon BCise*,**, Byetta*,**, Ozempic*,**, Rybelsus*,**, Trulicity*,**, Generic liraglutide*,^, Mounjaro*,**
*If being used for any other indications, deny the case for medical necessity and do not review for off-label use. **If patient meets criteria above, please approve at GPI-10. ***If patient meets criteria above, please approve at NDC level. ^If patient meets criteria above, please approve at GPI-12 level and with a MSC Y.
Prior Authorization (Initial Authorization)
Length of Approval: 1 Year(s)
For diagnosis of Diagnosis of type 2 diabetes mellitus (T2DM)
- Patient has a documented diagnosis of type 2 diabetes mellitus as evidenced by medical records documenting one of the following:
- A1C ≥ 6.5%
- Fasting plasma glucose (FPG) ≥ 126 mg/dL
- 2-hour plasma glucose ≥ 200 mg/dL during OGTT
- Random plasma glucose ≥ 200 mg/dL
- Minimum duration of a 30-day trial and failure, contraindication, or intolerance to metformin or another diabetic product (e.g. SGLT-2 Inhibitors, DPP4 Inhibitors, Glinides, Sulfonylureas, Alpha Glucosidase Inhibitors) AND
- One of the following:
- For Byetta, Mounjaro, Ozempic, or Rybelsus, patient is 18 years of age or older OR
- For Bydureon Bcise, Trulicity, or generic liraglutide, patient is 10 years of age or older
- Medication is not being co-administered with any of the following:
- GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity, Wegovy)
- Tirzepatide-containing products (e.g., Mounjaro)
Bydureon BCise*, Byetta**, Ozempic, Rybelsus, Trulicity*, Generic liraglutide^, Mounjaro*
**If patient meets criteria above, please approve at GPI-10. ***If patient meets criteria above, please approve at NDC level. ^If patient meets criteria above, please approve at GPI-12 level and with a MSC Y.
Prior Authorization (Reauthorization)
Length of Approval: 1 Year(s)
For diagnosis of Diagnosis of type 2 diabetes mellitus (T2DM)
- Documentation of a positive clinical response to therapy (e.g., reduction in HbA1c from baseline) AND
- Medication is not being co-administered with any of the following:
- GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity, Wegovy)
- Tirzepatide-containing products (e.g., Mounjaro)
Brand Victoza*,**
*If being used for any other indications, deny the case for medical necessity and do not review for off-label use. **If patient meets criteria above, please approve at GPI-10.
Non Formulary (Initial Authorization)
Length of Approval: 1 Year(s)
For diagnosis of Diagnosis of type 2 diabetes mellitus (T2DM)
- Patient has a documented diagnosis of type 2 diabetes mellitus as evidenced by medical records documenting one of the following:
- A1C ≥ 6.5%
- Fasting plasma glucose (FPG) ≥ 126 mg/dL
- 2-hour plasma glucose ≥ 200 mg/dL during OGTT
- Random plasma glucose ≥ 200 mg/dL
- Minimum duration of a 30-day trial and failure, contraindication, or intolerance to metformin or another diabetic product (e.g., SGLT-2 Inhibitors, DPP4 Inhibitors, Glinides, Sulfonylureas, Alpha Glucosidase Inhibitors) AND
- Patient is 10 years of age or older AND
- Medication is not being co-administered with any of the following:
- GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity, Wegovy)
- Tirzepatide-containing products (e.g., Mounjaro)
- Trial and intolerance to generic liraglutide AND
- Trial and failure, contraindication, or intolerance to two of the following:
- Mounjaro
- Ozempic or Rybelsus
- Trulicity
- Byetta or Bydureon BCise
Brand Victoza*
Non Formulary (Reauthorization)
Length of Approval: 1 Year(s)
For diagnosis of Diagnosis of type 2 diabetes mellitus (T2DM)
- Documentation of a positive clinical response to therapy (e.g., reduction in HbA1c from baseline) AND
- Medication is not being co-administered with any of the following:
- GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity, Wegovy)
- Tirzepatide-containing products (e.g., Mounjaro)
- Trial and intolerance to generic liraglutide AND
- Trial and failure, contraindication, or intolerance to two of the following:
- Mounjaro
- Ozempic or Rybelsus
- Trulicity
- Byetta or Bydureon BCise
Exenatide*,**
*If being used for any other indications, deny the case for medical necessity and do not review for off-label use. **If patient meets criteria above, please approve at GPI-10.
Non Formulary (Initial Authorization)
Length of Approval: 1 Year(s)
For diagnosis of Diagnosis of type 2 diabetes mellitus (T2DM)
- Patient has a documented diagnosis of type 2 diabetes mellitus as evidenced by medical records documenting one of the following:
- A1C ≥ 6.5%
- Fasting plasma glucose (FPG) ≥ 126 mg/dL
- 2-hour plasma glucose ≥ 200 mg/dL during OGTT
- Random plasma glucose ≥ 200 mg/dL
- Minimum duration of a 30-day trial and failure, contraindication, or intolerance to metformin or another diabetic product (e.g. SGLT-2 Inhibitors, DPP4 Inhibitors, Glinides, Sulfonylureas, Alpha Glucosidase Inhibitors) AND
- Patient is 18 years of age or older AND
- Medication is not being co-administered with any of the following:
- GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity, Wegovy)
- Tirzepatide-containing products (e.g., Mounjaro)
- Trial and failure, contraindication, or intolerance to three of the following:
- Mounjaro
- Ozempic or Rybelsus
- Trulicity
- Byetta or Bydureon BCise
Exenatide*,**
* If patient meets criteria above, please approve at GPI-10.
Non Formulary (Reauthorization)
Length of Approval: 1 Year(s)
For diagnosis of Diagnosis of type 2 diabetes mellitus (T2DM)
- Patient demonstrates positive clinical response to therapy (e.g., reduction in HbA1c from baseline) AND
- Medication is not being co-administered with any of the following:
- GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity, Wegovy)
- Tirzepatide-containing products (e.g., Mounjaro)
- Trial and failure, contraindication, or intolerance to three of the following:
- Mounjaro
- Ozempic or Rybelsus
- Trulicity
- Byetta or Bydureon BCise
P & T Revisions
1970-01-01, 2025-07-14, 2025-03-17, 2025-03-04, 2024-11-05
References
- Byetta Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. December 2022.
- Victoza Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. July 2023
- Trulicity Prescribing Information. Eli Lily and Company. Indianapolis, IN. April 2023
- Bydureon BCise Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. May 2023
- Ozempic Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. September 2023.
- Mounjaro Prescribing Information. Eli Lily and Company. Indianapolis, IN. September 2023.
- Rybelsus Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. January 2024.
- 8. American Diabetes Association (ADA) 2023 Standards of Care in Diabetes to Guide Prevention, Diagnosis, and Treatment for People Living with Diabetes. Accessed May 18, 2023.
End Notes
- In people with CKD, established CVD or multiple risk factors for CVD, the decision to use a GLP-1 RA with proven benefit should be independent of background use of metformin. The GLP-1 RAs that have shown proven benefit include Ozempic, Trulicity, and Victoza [9].
Revision History
- 2025-07-14: Added Exenatide Criteria. Added updated operational note for generic liraglutide to be approved at GPI-12 level with MSC Y, to reauthorization criteria.
- 2025-03-17: Update Program
- 2025-03-04: Updated criteria
- 2024-11-05: New Program
HEALTHY LIVING