NICE sounds costs concerns over BI's Jardiance, requests more data
- Jardiance (empagliflozin) is intended to be used in combination with oral antidiabetic drugs, with or without insulin, for the treatment of type 2 diabetes.
- The National Institute for Health and Care Excellence (NICE) wants revised estimates of Jardiance's incremental cost-effectiveness ratios that are based on a "validated economic model."
- NICE concedes that Jardiance is clinically effective, but insists that cost-effectiveness data is an important aspect of its overall approval process.
Jardiance is a sodium glucose co-transporter-2 (SGLT2) inhibitor that was co-developed by BI and Eli Lilly. It works by blocking reabsorption of glucose in the kidneys, leading to excretion of glucose and a lower blood-glucose level in the blood.
The drug was approved in early August by the FDA. Although the FDA has requested several post-marketing studies covering various clinical concerns, it never requested follow-up economic data. NICE is taking a very different tack. The agency has been very specific about the type of data it would like to see and how that data should be derived and presented, including the addition of comparator data and sensitivity analyses.
Analysts expect Lilly to pick up about $518 million in U.S. sales from Jardiance in 2019, according to Bloomberg.
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