Abbott Wins Landmark Reimbursement Decision in France

France has become the first country in Europe to expand national reimbursement coverage for Abbott's FreeStyle Libre 2 system to include all people who use basal insulin as part of their diabetes management. The continuous glucose monitoring (CGM) system was previously covered only for people who require intensive insulin therapy.

The French health authority's decision follows similar reimbursement coverage expansions for Abbott's CGM technology in Japan and the United States. Together, this represents 3 million more people living with the condition who are now eligible to use the Libre technology for diabetes management.

"We think this decision could help usher in additional expanded coverage wins in developed markets," Marie Thibault, a medtech analyst at BTIG, said in a report earlier this week.

"Our goal is to get our FreeStyle Libre technology to as many people as possible," said Jared Watkin, senior vice president of Abbott's diabetes care business. "The French national reimbursement decision is an important step in providing broader access to people with diabetes, and we are working with other countries to extend this coverage to more people."

The French reimbursement expansion was partly based on clinical data from the Real World Evidence of FreeStyle Libre (RELIEF) study. Abbott also said that a retrospective study of the French national claims database showed that the use of FreeStyle Libre by people with type 2 diabetes on once-daily (basal) insulin contributed to significant reductions in acute complications of diabetes, leading to a 67% decrease in hospitalizations.

"Studies have shown that FreeStyle Libre technology can help people with diabetes improve their glucose control, decrease diabetes-related hospital admissions, and reduce the burden associated with conventional self-monitoring of blood glucose," said Bruno Guerci, a professor in the Department of Endocrinology, Diabetology, and Nutrition at Brabois Adult Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France. "The expanded reimbursement for Abbott's FreeStyle Libre 2 now opens up access to allow a new group of patients to experience the benefits of continuous glucose monitoring, which was only available to those with type 1 or type 2 diabetes and following intensive insulin therapy."

In April, Abbott disclosed in a medical device correction that it had received some reports worldwide (0.0017%) from people who use the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 readers. These reports indicate that the lithium-ion battery in the readers have been known to swell, infrequently overheat, or, in very rare cases, spark or catch fire. The reader is the small handheld device that collects glucose readings directly from a CGM sensor to allow for real-time diabetes management.