Changing The Landscape Of Diabetes
MedImpact Investigates the Impact of Oral Semaglutide and Diabetes Market Trends
With the potential to change the landscape of diabetes treatment, oral semaglutide ushers in the next generation of diabetes care with its anticipated FDA approval in September.
First approved as a weekly injectable by the FDA in late 2018 under the brand name Ozempic, semaglutide falls in the blockbuster class of drugs known as glucagon-like peptide-1s (GLP-1s).
A non-insulin medication, GLP-1 receptor agonists treat Type 2 diabetes by lowering blood glucose levels and aiding in weight loss. They also can have positive effects on blood pressure, cholesterol levels, and beta-cell function.
Oral semaglutide will further increase the already rapidly growing market share of the entire GLP-1 class, potentially reaching $3 to $6 billion in peak annual blockbuster sales.
This growth will primarily occur due to a utilization shift from oral sodium-glucose co-transporter-2 inhibitors (SGLT2) and DPP-4 inhibitors (DPP4), although some patients may stick with other oral options due to drug-specific benefits, including SGLT2s in heart failure patients and DPP4s in frail patients.
Analysts also anticipate that an oral option of semaglutide will induce shifts from injectable GLP-1sas some patients will prefer it over injections.
Besides the blood glucose and weight-loss advantage, semaglutide has another positive feature: proven cardiovascular safety. A second application for cardiovascular risk reduction is slated for FDA approval in January 2020.
The Nation’s Diabetes Crisis
An estimated 30.3 million Americans — 9.4% of the U.S. population — have either type 2 diabetes or undiagnosed diabetes.1 And as many as 1 in 3 adults could have diabetes by 2050 if the current health crisis continues, according to recent CDC reports.2 The economic impact is also staggering: The estimated costs of diagnosed diabetes reached $327 billion in 2017, including $237 billion in direct medical costs and $90 billion in reduced productivity.3 Total annual medical and economic costs related to diabetes will increase 53% to more than $622 billion by 2030.4
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Clinical Indication & Efficacy
Based on results from 10 PIONEER clinical trials, which involved more than 9,500 adults with Type 2 diabetes, oral semaglutide was highly effective in controlling blood glucose and body weight compared with new generation diabetes drugs, including DPP-4 inhibitor Januvia (sitagliptin); SGLT2 inhibitor Jardiance (empagliflozin); and daily injectable GLP-1 agonist Victoza (liraglutide).
Safety and tolerability of oral semaglutide is in line with injectable members of the class, with the exception of higher rates of nausea, vomiting, and discontinuation at the highest dose. GI side effects usually wane after 16 weeks of treatment. Until now, developing an oral delivery has been a major challenge due to rapid enzymatic breakdown and poor intestinal protein absorption in the GI tract, requiring advanced technology to improve absorption of the drug to enable oral delivery.
Annual Trend Report: Diabetes Spotlight
Diabetes spending will continue to increase as new pipeline agents like oral semaglutide enter the market. For now, insulin still dominates the diabetes therapeutic class, accounting for 49% of market share. Newer generation, non-insulin products, like DPP4, SGLT2 or GLP-1s, or combinations that contain them, now make up a combined 50% of market share.
GLP-1 agonists and SGLT2 inhibitors have recently gained more market share than DPP-IV inhibitors due to their greater ability to reduce glucose levels and achieve positive morbidity and mortality study results.
Over the past five years, the rapidly growing GLP-1 market has experienced a remarkable 76% cost increase. GLP-1 list prices are increasing at a higher rate than insulin, which has increased by 54% since 2014.5
Top Diabetes 2018 Trends by Line of Business
Download the 2018 Annual Trend Report.
1 National Institutes of Health: https://www.niddk.nih.gov/health-information/health-statistics/diabetes-statistics