Sanofi-Aventis U.S., LLC recently agreed to pay $11.85 million to resolve allegations of Lemtrada kickbacks which violated the False Claims Act.
Sanofi paid kickbacks to Medicare patients through The Assistance Fund (TAF), a supposedly independent charity foundation, according to the U.S. Attorney’s office.
The multiple sclerosis drug Lemtrada (alemtuzumab) costs each patient almost $100,000 per year. Medicare co-pays for the drug can amount to several thousands of dollars per year and this often makes the drug difficult or impossible to obtain for Medicare patients.
The government says Sanofi sent payments to TAF with the purpose of using TAF to pay Medicare co-pays of Lemtrada patients. The government says these payments violated the Anti-Kickback Statute.
Sanofi worked with a third-party reimbursement hub to find Medicare patients who had been prescribed Lemtrada but couldn’t afford the co-pays. Sanofi then made payments to TAF and instructed its hub to refer as many Lemtrada patients as possible to TAF. This led to a disproportionately large number of Lemtrada patients receiving co-pay grants and a disproportionately small number of patients taking other MS drugs receiving co-pay grants.
“They rigged the system so those taking its drug Lemtrada gained an unfair advantage over patients using other medications, and with today’s settlement, they are finally being held accountable for their actions,” said Joseph R. Bonavolonta of the FBI’s Boston Division. “Sanofi sought to undermine the Medicare program through its use of kickbacks disguised as routine charitable donations aimed at helping patients battling multiple sclerosis and who were struggling with costly copays.”
“According to the allegations in today’s settlement agreement, Sanofi used a supposed charity as a conduit to funnel money to patients taking Sanofi’s very expensive drug, all at the expense of the Medicare program,” said U.S. Attorney Andrew Lelling.
The U.S. government has collected almost one billion dollars from pharma companies in the past two and a half years for kickback schemes such as this one. The schemes all included Patient Assistance Programs being used to drive Medicare patients towards high priced medications and away from less expensive generic medications. These schemes were sometimes timed to coincide with increases in the prices of the drugs the schemes were targeting.
The FDA warned in 2018 that some Lemtrada patients experienced strokes or tears in their artery linings within one day of taking Lemtrada. The FDA added a Boxed Warning, a.k.a. a black box warning, about the risk of stroke to Lemtrada’s label.