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

Self-Administration – injectable

Indications for Prior Authorization:
  • Adlyxin:
    • Adjunctive therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • Bydureon/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 improve glycemic control in type 2 diabetic patients who are compliant with metformin and have not achieved adequate glycemic control
    • 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 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, AND
  • Drug is not solely being used for weight loss, AND
  • Trial and failure, contraindication, or intolerance to a metformin-containing medication, AND
  • For Adlyxin only: Trial and failure or intolerance to two preferred GLP-1 agonists: Bydureon/Bydureon BCise, Byetta, Ozempic, Rybelsus, Trulicity, Victoza, and Mounjaro
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), AND
  • Drug is not solely being used for weight loss
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:
    • Adlyxin: 20 mcg once daily (6 mL per month)
    • Bydureon: 2 mg once weekly (4 pens/trays per month)
    • 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)
  • Adlyxin, Byetta, Mounjaro, Ozempic, Rybelsus, Trulicity: Indicated for 18 years of age or older
  • Bydureon/Bydureon BCise, 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:
  • 10/1/2022- GLP-1 agonist criteria combined into one policy and inclusion of Mounjaro. Updates to criteria requirements
  • 07/16/2021 - added indication for DM2 with established cardiovascular disease or multiple cardiovascular risk factors; updated maximum allowable dose; updated policy format
References: 
  • Byetta Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. November 2021. 
  • Victoza Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. December 2021. 
  • Bydureon Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. July 2021. 
  • Trulicity Prescribing Information. Eli Lily and Company. Indianapolis, IN. December 2021. 
  • Adlyxin Prescribing Information. Sanofi-Aventis U.S. LLC. Bridgewater, NJ. July 2021. 
  • Bydureon BCise Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. July 2021. 
  • Ozempic Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. March 2022.
  • Mounjaro Prescribing Information. Eli Lily and Company. Indianapolis, IN. May 2022.

Last review date: June 1, 2023