Appropriate Use of GLP-1 Agonists
GLP-1 agonists have become part of the standard of care in the treatment of Type II Diabetes according to the American Diabetes Association (ADA) guidelines.1 We would like to make you aware of the coverage and clinical considerations. The ADA now recommends other medications (including GLP-1 agonists) with or without metformin based on glycemic needs, are appropriate initial therapy for individuals with type II diabetes with or at high risk for atherosclerotic cardiovascular disease, heart failure, and/or chronic kidney disease1. Inappropriate prescribing of drugs like Ozempic and Mounjaro for treatment of obesity alone has contributed to shortages of these products for patients with Type II diabetes.2,3
While these products have proven to be effective for their respective indications, they are not without side effects/adverse reactions. The most common side effects are gastrointestinal-related, including loss of appetite, nausea, vomiting, and diarrhea. Additional issues have been identified with patients needing surgery when taking these medications. Due to the delayed gastric emptying feature of these drugs, it has been reported (at least anecdotally) that patients may have increased risk of regurgitation and pulmonary aspiration during general anesthesia and deep sedation.3 As a result, the American Society of Anesthesiologists have set guidelines for the holding GLP-1 agonists prior to elective procedures.4
All of these products, when coverage is available, require a prior authorization (PA). We have noted, in recent months, many requests for GLP-1 agonists (particularly Ozempic and Mounjaro) that appear to be intended for use outside of the FDA-approved indications for the particular product. Meridian Health Plan of Michigan will be actively monitoring and reviewing PA requests to ensure these medications are used only per their FDA-approved indications. Requests for documentation to substantiate attestations made in the PA request process may be required.
These products are available in a number of different forms and product names with varying FDA-approved indications (see Tables below).
Medication | FDA Approved Indication | Dosing Frequency/Route |
|---|---|---|
Dulaglutide (Trulicity) | Type II DM and pediatric patients ≥10 years of age with type 2 DM; reduction of cardiovascular mortality due to major cardiovascular events (MACE) in type II DM patients with established CV disease or multiple CV risk factors | Once weekly SQ injection |
Exenatide, extended-release (Bydureon BCise) | Type II DM, pediatric patients ≥10 years of with type 2 DM. | Once weekly SQ injection |
Exenatide (Byetta) | Type II DM | Twice daily SQ injection |
Liraglutide (Victoza) | Type II DM and pediatric patients ≥10 years of age with type 2 DM; reduction of CV mortality, non-fatal MI, or non-fatal stroke in persons with Type II DM and established CV disease | Once daily SQ injection |
Lixisenatide (Adlyxin) | Type II DM | Once daily SQ injection |
Semaglutide (Ozempic) | Type II DM; reduction of CV mortality, non-fatal MI, or non-fatal stroke in persons with Type II DM and established CV disease | Once weekly SQ injection |
Semaglutide oral (Rybelsus) | Type II DM | Once daily tablet |
Tirzepatide (Mounjaro) | Type II DM | Once weekly SQ injection |
Medication | FDA Approved Indication | Dosing Frequency/Route |
|---|---|---|
Liraglutide (Saxenda) | Obesity and pediatric patients ≥12 years of age with body weight >60 kg and an initial BMI corresponding to ≥30 kg/m2 for adults (obesity) by international cut-offs (Cole Criteria). | Once daily SQ injection |
Semaglutide (Wegovy) | Obesity and pediatric patients ≥12 years of age with an initial BMI at the ≥95th percentile standardized for age and sex; risk reduction of major adverse cardiovascular events (cardiovascular death, nonfatal MI, nonfatal stroke) in adults with established cardiovascular disease and either obesity or overweight. | Once weekly SQ injection |
Tirzepatide (Zepbound) | Obesity | Once weekly SQ injection |
*Covered and preferred products may vary by health plan or product. Please check the individual health plan website for specific coverage details.
References
- American Diabetes Association (ADA) Standards of Care in Diabetes – 2024.
- ASHP Drug Shortage Bulletin: Semaglutide Injection
- ASHP Drug Shortage Bulletin: Tirzepatide Injection
- American Society of Anesthesiologists Consensus-Based Guidance on Preoperative Management of Patients (Adults and Children) on Glucagon-Like-Peptide-1 (GLP-1) Receptor Agonists