According to the “National Diabetes Statistics Report” from the CDC, an estimated 30.3 million Americans had diabetes in 2017, 7.2 million of which were undiagnosed. Approximately 5% had type 1 diabetes and the remaining 95% had type 2 diabetes. Over the last 20 years, the number of adults with diabetes has more than tripled, and the total direct and indirect estimated cost of diagnosed diabetes in the U.S. in 2012 was $245 billion.
“Diabetes is the highest traditional overall drug spend category for commercial, Medicare D, and Medicaid clients; and among all drug categories, only autoimmune has a higher drug spend,” says April Kunze, PharmD, senior director, clinical formulary development and trend management strategy, Prime Therapeutics.“Given the prevalence and the opportunities where diabetes care can go wrong, it can be an ideal area connected to outcomes-based contracts,” explains Mark Ginestro, a principal from KPMG Strategy. “The proper management of the condition can lead to major savings in overall medical costs.”
While there are some exciting promises in the pipeline, recent activity has cast doubts on that pipeline’s future. The FDA recently denied approval for the investigational drug Zynquista (sotagliflozin, Sanofi and Lexicon Pharmaceuticals) for type 1 diabetes.
Zynquista works by inhibiting both sodium-glucose cotransporter 2 (SGLT2), a transporter responsible for most of the glucose reabsorption performed by the kidney, and sodium-glucose cotransporter 1 (SGLT1), a transporter responsible for glucose and galactose absorption in the gastrointestinal tract.
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The agency issued a Complete Response Letter (CRL) in March, following an eight to eight vote by the FDA’s advisory committee in January in favor of the drug’s benefits outweighing its risks.
“Given the advisory committee’s vote it is not entirely surprising that the FDA has issued a CRL for the Zynquista New Drug Application (NDA),” Kunze says. “Other SGLT2 inhibitors are being studied for use in type 1 diabetes. Currently, SGLT2 inhibitors are approved for the treatment of type 2 diabetes.”
Farxiga (dapagliflozin, AstraZeneca), one of the SGLT2 inhibitors currently approved for type 2 diabetes, was recently approved for type 1 in Europe and is currently undergoing studies in the U.S.—but Zynquista’s rejection has cast doubts on its future in the United States.
SGLT2 inhibitor manufacturers are also studying overall health outcomes, such as major cardiac events and sub-populations within diabetic patients, including those with chronic kidney disease or heart failure, to show potential benefit and expand labeled indications, according to Kunze.
The role of tech in diabetes management
Technology also has an important role to play, with wearable devices, such as continuous glucose monitors (CGMs) that aid in the diagnosis, treatment, and self-management of diabetes. Ginestro also says that medical device makers have introduced different variations of the “artificial pancreas,” an automated insulin pump with a CGM for management of patients with type 1 diabetes.