GLP-1 Agonists (Bydureon BCise, Byetta, Ozempic, Rybelsus, Trulicity, Victoza) & GIP/GLP-1 Agonist (Mounjaro)

GLP-1 Agonists (Bydureon BCise, Byetta, Ozempic, Rybelsus, Trulicity, Victoza) & GIP/GLP-1 Agonist (Mounjaro)

Self-Administration – injectable

Indications for Prior Authorization:

• Bydureon BCise:
  • Adjunctive therapy to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus
• Byetta:
  • Adjunctive therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• Ozempic:
  • Adjunctive therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • 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
• Rybelsus:
  • Adjunctive therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• Trulicity:
  • Adjunctive therapy to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus
  • 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
• Victoza:
  • Adjunctive therapy to diet and exercise to improve glycemic control in patients 10 years of age and older with type 2 diabetes mellitus
  • 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
• Mounjaro: 
  • Adjunctive therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Coverage Criteria:

For diagnosis of type 2 diabetes mellitus (DM2):

• 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, AND
• Minimum duration of a 30-day trial and failure, contraindication, or intolerance to metformin or another diabetic product

Reauthorization Criteria:

For diagnosis of type 2 diabetes mellitus (DM2):

• Documentation of a positive clinical response to therapy (e.g., reduction in HbA1c from baseline)

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The following indications do not meet the criteria for use established by the Western Health Advantage Pharmacy and Therapeutics Committee:

• Treatment of type 1 diabetes
• Treatment of ketoacidosis
• Appetite suppression or treatment of obesity

Additional Information:

• FDA maximum dose:
  • Bydureon BCise: 2 mg once weekly (3.4 mL per month)
  • Byetta: 10 mcg twice a day (2.4 mL per month)
  • Ozempic: 2 mg once weekly (3 mL per month)
  • Rybelsus: 14 mg once daily (30 tablets per month)
  • Trulicity: 4.5 mg once weekly (2 mL per month)
  • Victoza: 1.8 mg once daily (9 mL per month)
  • Mounjaro: 15 mg once weekly (2 mL per month)
• Byetta, Mounjaro, Ozempic, Rybelsus: Indicated for 18 years of age or older
• Bydureon BCise, Trulicity, Victoza: Indicated for 10 years of age or older
• Treatment guidelines do not support safety and efficacy of GLP-1 agonists when used in combination with a DPP4 inhibitor agent (e.g. alogliptin, linagliptin, sitagliptin, saxagliptin)

Policy Updates:

• Effective 7/16/2021 - added indication for DM2 with established cardiovascular disease or multiple cardiovascular risk factors; updated maximum allowable dose; updated policy format
• Effective 10/1/2022- GLP-1 agonist criteria combined into one policy and inclusion of Mounjaro. Updates to criteria requirements (P&T vote, 9/23/2022)
• Effective 7/1/2024 – removed Adlyxin and Bydureon pen to criteria and updates to criteria requirements (P&T, 5/21/2024)

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.