Sanofi's ($SNY) new diabetes drug has hit a setback in Germany. The country's increasingly strict pricing regulators say Lyxumia delivers "no additional benefit" compared with existing drugs. If the decision sticks, Sanofi will lose the power to price Lyxumia at a brand-name premium.
The Institute for Quality and Efficiency in Healthcare, also known as IQWiG, gave Sanofi an opening to change the verdict, however. The agency said its decision was based on lack of data, rather than on actual evidence. IQWiG said Sanofi's studies didn't properly compare Lyxumia to alternative treatments. The company didn't submit data showing Lyxumia's performance as a metformin add-on, in comparison with the older combination of sulfonylurea plus metformin. Nor did it compare Lyxumia plus sulfonylurea with the sulfa-metformin combo.
Meanwhile, Sanofi's data comparing Lyxumia in combination with basal insulin versus human insulin wasn't "suitable," the agency said. IQWiG also wanted Sanofi to compare Lyxumia plus metformin and sulfonylurea against metformin plus human insulin. Sanofi needs to provide a "direct comparative study" between Lyxumia and "the appropriate comparator therapy" for any or all of the four proposed indications, the agency said.
Sanofi has till July 8 to come forward with new data or data analyses. Lyxumia was approved in Europe in February, but it hasn't yet won approval in the U.S. Though the drug has launched in the U.K., the National Institute for Health and Care Excellence has not weighed in on the drug's cost-effectiveness.