Need help or have questions about your order? Call 510-991-8265Questions about your order? Call 510-991-8265

Sign InShop GLPs
Shop GLPs

GLP-1 Receptor Agonists Billing & Prior-Auth Playbook

By
Published Updated Last reviewed
13 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • Weight-management labels / Wegovy injection and tablets, Saxenda and generic liraglutide, Zepbound, Foundayo [1][2][3][4]
  • Diabetes-indication labels / Ozempic, Ozempic tablets, Rybelsus, Victoza, Trulicity, Byetta, Mounjaro, Soliqua, Xultophy [5][6][7][8][9][10][11][12]
  • Tirzepatide / dual GIP and GLP-1 receptor agonist, not a pure GLP-1 agonist [3][10]
  • Compounded semaglutide and tirzepatide / not FDA approved [13]
  • Prescription status / every US product is a prescription injection or tablet; none is over the counter [1][4]

What does FDA labeling establish?

The label gives the approved indication, dosing, warnings, interactions and adverse reactions. It does not set a plan's coverage rules. The indication is the part a coverage request can be built on, because it differs by product [1][4].

Which products have a weight-management indication?

Wegovy injection and tablets, Saxenda and generic liraglutide, Zepbound and Foundayo carry weight-management indications [1][2][3][4]. Saxenda is also labeled for children 12 and older weighing more than 60 kg with obesity [2]. Foundayo has no diabetes indication [4].

Which are labeled for type 2 diabetes?

Ozempic, Ozempic tablets, Rybelsus, Victoza, Trulicity, Byetta, Mounjaro, Soliqua and Xultophy carry type 2 diabetes indications [5][6][7][8][9][10][11][12]. Trulicity has no weight-loss indication [8]. Tirzepatide is a dual GIP and GLP-1 receptor agonist, not a pure GLP-1 agonist [3][10].

Indication by product

  • Wegovy injection: weight reduction in adults and children 12 and older with obesity, cardiovascular risk reduction, and MASH. Wegovy tablets: weight reduction and cardiovascular risk reduction in adults [1].
  • Saxenda and generic liraglutide for weight: weight management in adults with obesity, or overweight plus a comorbidity, and in children 12 and older weighing over 60 kg with obesity [2].
  • Zepbound: weight and obstructive sleep apnea [3]. Foundayo: weight reduction and long-term weight maintenance in adults with obesity, or overweight plus a weight-related comorbidity [4].
  • Ozempic: type 2 diabetes, cardiovascular risk reduction in type 2 diabetes with established cardiovascular disease, and kidney outcomes in type 2 diabetes with chronic kidney disease [5]. Rybelsus and Ozempic tablets: type 2 diabetes and cardiovascular risk reduction [6].
  • Victoza: type 2 diabetes in adults and children 10 and older, and cardiovascular risk reduction in adults with type 2 diabetes and established cardiovascular disease [7]. Trulicity: type 2 diabetes in adults and children 10 and older, and cardiovascular risk reduction in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors [8].
  • Byetta: type 2 diabetes in adults [9]. Mounjaro: type 2 diabetes [10]. Soliqua and Xultophy: adults with type 2 diabetes, as combinations with insulin [11][12].

What about compounded semaglutide and tirzepatide?

Compounded semaglutide and tirzepatide are not FDA approved, and FDA does not review compounded drugs for safety, effectiveness or quality [13].

Combining GLP-1 drugs in a request

The Wegovy, Saxenda, Zepbound and Foundayo labels all state that combining with another GLP-1 receptor agonist is not recommended [1][2][3][4].

Frequently asked questions

Does FDA approval decide whether a GLP-1 drug is covered?
No. The label sets the approved indication; the patient's plan sets prior authorization, step therapy and appeal rules.
Which GLP-1 drugs are FDA approved for weight management?
Wegovy injection and tablets, Saxenda and generic liraglutide, Zepbound and Foundayo [1][2][3][4].
Which are FDA approved for type 2 diabetes?
Ozempic, Ozempic tablets, Rybelsus, Victoza, Trulicity, Byetta, Mounjaro, Soliqua and Xultophy [5][6][7][8][9][10][11][12].
Is compounded semaglutide FDA approved?
No. Compounded semaglutide is not FDA approved and is not reviewed for safety, effectiveness or quality [13].
Can two GLP-1 drugs be combined?
The Wegovy, Saxenda, Zepbound and Foundayo labels all state that concomitant use with another GLP-1 receptor agonist is not recommended [1][2][3][4].

References

  1. U.S. National Library of Medicine, DailyMed. Wegovy injection and tablets prescribing information. Wegovy injection and tablets label
  2. U.S. National Library of Medicine, DailyMed. Saxenda injection (liraglutide) prescribing information. Saxenda injection (liraglutide) label
  3. U.S. National Library of Medicine, DailyMed. Zepbound injection (tirzepatide) prescribing information. Zepbound injection (tirzepatide) label
  4. U.S. National Library of Medicine, DailyMed. Foundayo (orforglipron) tablets prescribing information. Foundayo (orforglipron) tablets label
  5. U.S. National Library of Medicine, DailyMed. Ozempic injection prescribing information. Ozempic injection label
  6. U.S. National Library of Medicine, DailyMed. Rybelsus and Ozempic tablets (oral semaglutide) prescribing information. Rybelsus and Ozempic tablets (oral semaglutide) label
  7. U.S. National Library of Medicine, DailyMed. Victoza injection (liraglutide) prescribing information. Victoza injection (liraglutide) label
  8. U.S. National Library of Medicine, DailyMed. Trulicity injection (dulaglutide) prescribing information. Trulicity injection (dulaglutide) label
  9. U.S. National Library of Medicine, DailyMed. Byetta injection (exenatide) prescribing information. Byetta injection (exenatide) label
  10. U.S. National Library of Medicine, DailyMed. Mounjaro injection (tirzepatide) prescribing information. Mounjaro injection (tirzepatide) label
  11. U.S. National Library of Medicine, DailyMed. Soliqua 100/33 (insulin glargine and lixisenatide) prescribing information. Soliqua 100/33 (insulin glargine and lixisenatide) label
  12. U.S. National Library of Medicine, DailyMed. Xultophy 100/3.6 (insulin degludec and liraglutide) prescribing information. Xultophy 100/3.6 (insulin degludec and liraglutide) label
  13. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss | FDA. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss | FDA
Evidence overview for GLP-1 Receptor Agonists Billing & Prior-Auth Playbook