What If 100 Million Americans Could Benefit From a Life-Altering Therapy?

This year may see an explosion of use of glucagon-like peptide-1 (GLP-1) products.

GLP-1 medications have been used for treating diabetes since exenatide (Byetta) was approved in 2005.

Since then, GLPs have become a staple for diabetes care, growing in use for nearly 2 decades.

Man holding a semaglutide pen | Image credit: MySkin - stock.adobe.com

Yet one GLP-1 (semaglutide) has more than doubled in prescription volume year over year and now faces a shortage that may last for months because of a spike in demand for off-label prescribing for medically assisted weight loss. A favorite among prescribers who paid attention to clinical trials data that showed significant weight loss as a secondary end point, GLP use began to accelerate exponentially, having been popularized by billionaires and jet-setters like Elon Musk. Now mainstream health care professionals are feeling increasingly comfortable prescribing GLPs for weight loss to the masses.

Hard to Argue With Benefits for Many

A 15% loss of weight after a year of use is an eye-opener for anyone looking to shed 30 to 45 lb. Add to that lower hemoglobin levels and reduced risk for a host of poor outcomes from a malfunctioning metabolism and it is hard to argue against the widespread use of GLPs. Nearly 40 million Americans have type 2 diabetes,¹ and more than 100 million Americans are obese.² Add to those numbers potential interest for testing use for addiction disorders for alcohol and illicit and nonillicit drugs3 and GLPs become a potential juggernaut for widespread use during the next few years.

So, what does society do with medications that might benefit most of the population?

At well over $1000 per month out of pocket for many patients and likely pushing $2000 per month for the near future, semaglutide has the potential for tens (and perhaps hundreds) of billions of dollars in product sales in the near future. As it or similar products enter the marketplace, simple math (that is, if 10 to 11 zeros make it easy) says that even at $1000 per month, across 100 million individuals, a societal bill of greater than $1 trillion per year is possible. That is roughly a quarter of the nation’s health care bill. If GLPs continue to rise in popularity, should alternative procurement parameters be employed? Do we view these products more like vaccines for the good of public health? What if we find that they help prevent Alzheimer disease and other forms of dementia? We could be reaching uncharted territory with GLPs and other emerging groundbreaking products, from questions about access and affordability to how patients access them, via widespread telemedicine and telepharmacy.

Gene Therapies on Horizon

Lurking in the background is an explosion of gene therapies about to come to market. With 122 clinical trials in 2022,⁴ and thousands of promising gene therapies in the pipeline, yet another $100 billion marketplace emerges. Gene therapies have been mostly designed for rare diseases, a godsend for the many patients with esoteric diseases only treatable with gene therapies. But what happens if a gene therapy, which often carries a list price of 6 or even 7 figures, is approved for a disease that is widespread, such as diabetes or depression?

Medicare, the Inflation Reduction Act, and the Future of Drug Coverage

As Medicare goes, so often goes coverage strategies and price points for the rest of us. The recently passed Inflation Reduction Act of 2022 brought with it a first-of-its-kind test of government price setting, targeting the top specialty product therapies in the marketplace based on the total bill to Uncle Sam and complicated language around the type of drug (eg, biologics), whether competitors exist, and the number of years removed from federal approval of the therapy. Under the law, the government will negotiate a “maximum fair price.” Even though these government-set prices are set to roll out in 2026, the list of medications is set to be published later this year to ensure time to negotiate and roll out the program. No doubt GLPs and drugs like them will be the “talk of the town” in health policy and lobbying circles for the near future. Given the potential scale and size of emerging groundbreaking therapies, this may even lead to new discussions about modernizing how we invest in, pay for, and distribute them.

About the Author

Troy Trygstad, PharmD, PhD, MBA, is the executive director of CPESN USA, a clinically integrated network of more than 3500 participating pharmacies.

References

1. Type 2 diabetes. CDC. Updated December 30, 2022. Accessed April 4, 2023. https://www.cdc.gov/diabetes/basics/type2.html#:~:text=More%20than%2037%20million%20Americans,adults%20are%20also%20developing%20it

2. Adult obesity facts. CDC. May 17, 2022. Accessed April 4, 2023. https://www.cdc.gov/obesity/data/adult.html

3. Klausen MK, Thomsen M, Wortwein G, Fink-Jensen A. The role of glucagon-like peptide 1 (GLP-1) in addictive disorders. Br J Pharmacol. 2022;179(4):625-641. doi:10.1111/bph.15677

4. Hunt T. The cell and gene therapy sector in 2023: a wave is coming – are we ready? In Vivo. January 9, 2023. Accessed April 4, 2023. https://invivo.pharmaintelligence.informa.com/IV146781/The-Cell-And-Gene-Therapy-Sector-In-2023-A-Wave-Is-Coming--Are-We-Ready