The class of GLP-1 receptor agonists and similar agents, originally approved to treat type 2 diabetes, also reduce body weight and reduce CVD risk; what's next?
The demand for semaglutide and other GLP-1 receptor agonist drugs that treat obesity is only expected to increase especially as these therapies demonstrate they have benefits beyond weight loss.
Prevalence of obesity in the US increased from 30.5% during the period 1999 to 2000 to 41.9% during the period 2017 to March 2020, according to the Centers for Disease Control and Prevention. Obesity-related conditions, such as heart disease, stroke, type 2 diabetes (T2D), and certain types of cancer, are among the leading causes of preventable death.
Drugs like Ozempic and Wegovy, 2 semaglutide products made by Novo Nordisk, as well as Eli Lilly's Mounjaro (tirzepatide), mimic a gut hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. They were originally approved to treat patients with T2D.
This category of drugs is growing and contributing to almost 41% of total market sales growth in 2022. Ozempic and Mounjaro have driven most of the volume growth among GLP-1 agonists in 2022, according to data presented by Doug Long, vice president of industry relations of IQVIA at the Pharmacy Benefit Management Institute’s annual conference in Orlando.
But these are also high-cost drugs. Wegovy, for example, has a price of $1349.02 per package, or $16 188.24 per year. Mounjaro, which is already available to treat T2D, is awaiting approval by the FDA for a weight loss indication. Its list price is $1023.04 per package. According to IQVIA, Lilly’s Mounjaro is the best performing product by sales since Harvoni, a curative hepatitis C treatment, and is outpacing other noninsulin diabetes products.
It's likely the use of the GLP-1 mimetics will increase as they demonstrate other benefits, such as lowering the risk of heart disease. In August, Novo Nordisk released data that showed semaglutide reduced risk the risks of cardiovascular events, including lowering symptoms of a hard-to-treat type of heart failure. Novo Nordisk noted in a press release that the company plans to file for a label expansion based on these results.
The demand for these drugs was fueled by social media and direct-to- consumer advertising, Kerri Tanner, PharmD, chief pharmacy officer at consultant PayerAlly, said during a panel discussion at PBMI.
“We have a class of product that has all of a sudden taken off,” she said. “Now the number of patients who are diagnosed as either prediabetic or diabetic has also taken off. There are a lot of questions now about how to control it.”
Tanner said formulary coverage at many insurers and PBMs is using body mass index (BMI) as a criterion for coverage of GLP-1 agonist products. “But about 40% of the population would qualify. So now there are a lot of questions from plan sponsors about maybe increasing the requirements around the use of the GLP-1 to those who are obese by BMI standards or having patients step through a lower cost medication first.”
From a PBM perspective, there isn’t a funding mechanism for the GLP-1 receptor agonists other than the offset of the rebate, Dan Richards, head of commercial sales at Scripius, said during the panel discussion. Scripius (formerly Select Health Prescriptions) is part of Select Health, a nonprofit health plan that serves more than 1 million members in Utah, Idaho and Nevada.
“From a health plan perspective, to create a benefit around GLP-1, it would have to be actuarially sound and funded with premium,” he said. “There's an opportunity for health plans to work alongside their PBM to identify ways to create a benefit design that also includes a weight loss program in addition to the use of GLP-1. If we can do that through an integrated effort, I think we can get in front of this.”
Richards also said its important to work with physicians on the topic of who would be the appropriate patients for GLP-1 agonist treatment. “We saw that physicians were originally super focused on putting everybody on the drug. We’re asking them to take a step back to look at whether cardiovascular risk could be addressed with SGLT-2s (sodium-glucose co-transporter-2 inhibitors),” he said. SGLT-2 inhibitors include drugs such as Farxiga and Jardiance.