Keeping the Diagnoses Straight for GLP-1 Products

The FDA recently announced that Zepbound® (tirzepatide) has been approved for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity. This is the first GLP-1 indicated for OSA. The popularity of GLP-1 products has not slowed down, but with the new diagnosis for Zepbound® it is a good time to review the GLP-1 products and their FDA-approved diagnoses. 

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Many PBMs DO NOT require a diagnosis code to be on the prescription or to submit the diagnosis code at the time of adjudication. However, it is important that the correct product is being dispensed for the proper diagnosis.

In the December 2023 Newsline, Zepbound® (tirzepatide) Means Decreased Audit Risk…Right?, off-label uses of GLP-1 products were discussed. Medicare part D plans require that drugs are prescribed for medically accepted indications. Other PBMs have language in the Provider Manuals that define “clean claims” as one that is used for a medically accepted indication or outlines “appropriate dispensing practices”.  The chart below summarizes the current diagnoses for the approved GLP-1 products.

GLP-1 generic nameGLP-1 brand nameApproved indication(s)
LiraglutideVictoza®Type 2 diabetes in adults and children 10 years or olderType 2 diabetes in adults with known heart disease
Saxenda®Weight loss in adults and children 12 years or older
 
DulaglutideTrulicity®Type 2 diabetes in adults and children 10 years or olderReduce cardiovascular events in adults with type 2 diabetes with established cardiovascular disease or multiple risk factors
 
SemaglutideOzempic®Improve glucose in adults with type 2 diabetesReduce risk of cardiovascular events in adults with type 2 diabetes with known heart disease
Wegovy®Reduce risk of cardiovascular events in adults with type 2 diabetes with known heart disease AND either obesity or overweightAdults and children 12 and older with obesityOverweight adults who have weight-related medical problems
 
TirzepatideMounjaro®Adults with type 2 diabetes to improve blood sugar
Zepbound®Moderate-to-severe obstructive sleep apnea in adults with obesityObesity in adultsOverweight adults who have at least 1 weight-related comorbid condition

PAAS Tips:

Erin McDonald, PharmD