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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.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.Total annual medical and economic costs related to diabetes will increase 53% to more than $622 billion by 2030.4

CASE STUDY SPOTLIGHT

Learn how MedImpact is partnering with Bon Secours Mercy Health to help combat the diabetes epidemic.

To see how we can help you achieve significant clinical and financial results, download the full case study here.

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 receptor agonists (GLP-1) help lower blood glucose levels, by stimulating insulin release and delaying gastric emptying which increases feelings of fullness
  • Sodium-glucose co-transporter-2 (SGLT2) inhibitors are oral anti-hyperglycemic agents that help inhibit glucose reabsorption in the kidney to lower blood sugar
  • DPP-4 inhibitors (DPP4) block the enzyme that destroys incretins (gastrointestinal hormones that stimulate insulin production) to help regulate blood sugar levels

 

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

COMMERCIAL

  • Diabetes drugs accounted for the top four branded agents, with Humalog topping the list, followed by Lantus, Trulicity, and Victoza respectively
  • Diabetes kept its rank as the second highest therapeutic class in 2018 and saw an 8.9% unit-cost spike
  • For the second year in a row, the highest trend increase in traditional branded drugs was Trulicity, a GLP-1 receptor agonist, which moved from #8 to #3

MEDICARE

  • Diabetes remained the top therapeutic class in 2018 and accounted for 18.4% of overall Medicare spend
  • Five different diabetes drugs made the top 10 list, accounting for 43% of total diabetes PMPY spend. However, with increasing pressure on insulin pricing, these agent's ranking could decrease in 2019
  • Insulin medication Lantus topped the list for 2018 traditional brand spend while Januvia ranked the highest for non-insulin therapies

MEDICAID

  • Diabetes was the highest ranked Medicaid therapeutic class in 2018 and saw an 11.2% trend increase from 2017
  • Five diabetes drugs appeared in the top 10, with Lantus remaining as the first ranked drug in 2018
  • Basaglar, the first follow-on insulin product approved in 2015, ranked #3 on the top 10 list for traditional Medicaid drug spend, moving up from 20th in 2017

Download the 2018 Annual Trend Report.

Check MedConnect regularly for more drug trend insights from our 2018 MedImpact Annual Trend Report.

1 National Institutes of Health:  https://www.niddk.nih.gov/health-information/health-statistics/diabetes-statistics
2   CDC: https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html
National Institutes of Health: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278808/
American Diabetes Association: http://www.diabetes.org/advocacy/news-events/cost-of-diabetes.html
IQVIA: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicine-use-and-spending-in-the-us-a-review-of-2017-and-outlook-to-2022.pdf?_=1560467228282

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