As CMS maintains limits on GLP-1 coverage for weight loss, new efficacy data and shifting prescribing patterns point to sustained high demand across the drug class.
Here are four updates:
1. Federal policy
In early April, CMS rejected a Biden-era proposal to allow Medicare coverage of GLP-1 medications when prescribed solely for weight loss. Medicare currently covers GLP-1 drugs for Type 2 diabetes and heart disease, but CMS said it might revisit the weight loss policy in the future.
2. GLP-1 efficacy findings
In a phase 3 trial, Eli Lilly’s experimental weight loss medication, orforglipron, significantly lowered average A1C levels and reduced body weight in adults with Type 2 diabetes. The drugmaker said April 17 it plans to submit for regulatory approval for weight management by late 2025 and for diabetes in 2026.
Another Eli Lilly-sponsored study compared Mounjaro (tirzepatide) and Trulicity (dulaglutide), two of its GLP-1 drugs for diabetes, in a head-to-head trial. After 40 weeks, Mounjaro resulted in greater weight loss and better glucose control than Trulicity.
In an attempt to enter the lucrative GLP-1 medication market, which is currently dominated by Eli Lilly and Novo Nordisk, Pfizer was developing an oral GLP-1 weight loss drug. On April 14, Pfizer announced the therapy’s discontinuation after a study participant experienced a liver injury potentially related to the drug.
3. Utilization trends
Between January 2021 and December 2023, GLP-1 prescriptions for diabetes patients increased while metformin prescriptions declined, a recent study found.
In 2021, 13% of diabetes patients started GLP-1 drugs, and by late 2023, the rate grew to 35%. Metformin, the most commonly started glucose-lowering medicine in 2021 with a 30% start date, declined to 19% by late 2023.
A different study, which analyzed GLP-1 spending and utilization patterns, found that non-diabetic U.S. adults spent $5.8 billion on these drugs in 2022. The number of non-diabetic adults using GLP-1s more than tripled from 2018 to 2022, growing from 0.1% to 0.4% of the U.S. population, according to the study.
4. A new potential use
Researchers are investigating several potential uses in the GLP-1 drug class, including Alzheimer’s disease, addiction and depression. In a mouse clinical study led by the Monell Chemical Senses Center in Philadelphia, findings suggest that GLP-1s could be used for a rare genetic disorder.
Bardet-Biedl Syndrome, which is characterized by early-onset obesity, compulsive eating and cognitive impairments, affects approximately 1 in 150,000 newborns. When a genetically engineered mouse model of Bardet-Biedl Syndrome received a GLP-1, the researchers noted reduced food intake, improved glucose tolerance, normalized metabolic hormone levels and weight loss in the animals. The Journal of Clinical Investigation published the study April 15.
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