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.
Last review date: July 1, 2024