What are the guidelines for insurance coverage of Glucagon-like peptide-1 (GLP-1) receptor agonists?

Guidelines for Insurance Coverage of GLP-1 Receptor Agonists

GLP-1 receptor agonists are recommended for patients with type 2 diabetes and established cardiovascular disease, chronic kidney disease, or high cardiovascular risk, regardless of baseline HbA1c levels, and insurance coverage should prioritize these high-risk populations. 1

Medical Indications for GLP-1 Receptor Agonist Coverage

• GLP-1 receptor agonists are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 2
• GLP-1 receptor agonists are also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease 2
• For patients with type 2 diabetes and chronic coronary syndrome (CCS), GLP-1 receptor agonists with proven cardiovascular benefit are recommended to reduce cardiovascular events, independent of baseline or target HbA1c and independent of concomitant glucose-lowering medication 1
• For patients with type 2 diabetes and peripheral arterial and aortic diseases (PAAD), GLP-1 receptor agonists with proven cardiovascular benefit are recommended to reduce cardiovascular events, independent of baseline or target HbA1c and concomitant glucose-lowering medication 1

Current Coverage Patterns and Implementation Challenges

• Despite strong recommendations, GLP-1 receptor agonist utilization remains low, with only 6.8% of patients with diabetes and CKD being prescribed a GLP-1 receptor agonist according to the CURE-CKD Registry (2019-2020) 1
• In patients with commercial health insurance as recently as 2020, GLP-1 receptor agonist initiation was reported in only 17% of patients with diabetes and CKD 1
• High medication costs are a significant barrier to implementation, requiring efforts to increase access and reduce financial barriers 1
• Liraglutide is expected to be the first GLP-1 receptor agonist with kidney and cardiovascular benefits to obtain generic status, possibly in 2024, which may improve insurance coverage 1

Priority Populations for Coverage

• Patients with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD) should receive highest priority for GLP-1 receptor agonist coverage 1
• Patients with type 2 diabetes without established CVD but with indicators of high risk (age ≥55 years with coronary, carotid, or lower extremity artery stenosis >50%, left ventricular hypertrophy, eGFR <60 mL/min/1.73m², or albuminuria) should also be considered for coverage 1
• Patients with chronic kidney disease and type 2 diabetes should be covered for GLP-1 receptor agonists based on evidence of cardiovascular and renal benefits 1, 3
• Patients with obesity and weight-related comorbidities may also benefit from GLP-1 receptor agonist coverage, even without type 2 diabetes 4

Decision-Making Algorithm for Coverage Determination

1. First tier (highest priority for coverage): Patients with type 2 diabetes and established ASCVD 1
2. Second tier: Patients with type 2 diabetes and CKD 1, 3
3. Third tier: Patients with type 2 diabetes at high cardiovascular risk without established ASCVD 1
4. Fourth tier: Patients with type 2 diabetes requiring improved glycemic control and weight management 4, 5
5. Fifth tier: Patients with obesity and weight-related comorbidities without diabetes 4

Specific GLP-1 Receptor Agonist Selection Criteria

• For cardiovascular risk reduction, prioritize GLP-1 receptor agonists with proven cardiovascular benefits (liraglutide, semaglutide, dulaglutide) 1, 6
• For patients with heart failure risk, SGLT2 inhibitors may be preferred over GLP-1 receptor agonists 1
• For patients with osteoporosis, prior amputations, severe peripheral artery disease, peripheral neuropathy, or active lower extremity soft tissue ulcers or infections, GLP-1 receptor agonists may have a more favorable benefit/risk balance than SGLT2 inhibitors 1

Common Pitfalls and Caveats in Coverage Decisions

• Insurance coverage for GLP-1 receptor agonists varies significantly, creating barriers to access for many patients 1
• Prior authorization requirements often focus solely on glycemic control rather than cardiovascular risk reduction benefits 1
• Failure to recognize the cardiovascular and renal benefits of GLP-1 receptor agonists independent of glycemic control may lead to inappropriate coverage denials 1
• Switching between GLP-1 receptor agonists may be clinically beneficial but is often restricted by insurance formularies 7
• Requiring failure of multiple oral agents before covering GLP-1 receptor agonists may delay appropriate therapy for high-risk patients 1

Recommendations for Insurance Policy Improvement

• Insurance coverage policies should align with current clinical guidelines that recommend GLP-1 receptor agonists for cardiovascular risk reduction independent of baseline HbA1c 1
• Prior authorization criteria should include cardiovascular and renal risk factors, not just glycemic control parameters 1
• Step therapy requirements should be flexible for high-risk patients who would benefit from earlier GLP-1 receptor agonist initiation 1
• Coverage policies should account for the proven benefits of GLP-1 receptor agonists in reducing major adverse cardiovascular events, which may offset long-term healthcare costs 1, 3