Feds suspect misuse of Nuedexta to calm nursing home dementia residents
Nuedexta is the only drug approved to treat uncontrolled laughing and crying due to pseudobulbar affect.
It's a rare condition in or out of nursing homes, yet the U.S. government is cautioning private insurers to look for suspicious off-label use there because officials fear the drug is being misused to control unruly behavior.
A CNN investigation published in October found Nuedexta's maker had been “aggressively targeting frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe."
In a follow-up article published Monday, the news organization said the Centers for Medicare & Medicaid Services issued a March memo asking Medicare Part D providers to monitor prescriptions for appropriate use.
The CMS memo told plan sponsors that Nuedexta is only approved to treat pseudobulbar affect, and that they are legally required to ensure the drug is only covered for medically-accepted prescriptions. Both Aetna and CVSHealth said they had put new safeguards like prior authorization in place over the last year.
Neudexta's maker, Avanir Pharmaceuticals, has said that many dementia patients suffer from PBA. Since the drug launched in 2011, CNN reports Avanir has generated millions of dollars in annual sales in nursing homes.
It's the federal government that picks up most of those bills, and CNN unearthed what seems to be a concentrated effort to keep the increasingly controversial drug in nursing home's formularies.
The station obtained complaints sent to the Food and Drug Administration from insurers and nursing home physicians who questioned the maker's marketing and advertising tactics.
"I am concerned with the off label promotion of Nuedexta for diagnosis other than PBA," read one redacted complaint. "Specifically they are targetting [sic] residents with Dementia with Behavioral Disturbances."
Avanir said in a statement that it "is committed to the safe, effective use of NUEDEXTA for the treatment of patients with PBA."
"We take seriously our role in educating patients, caregivers and health care providers about NUEDEXTA and PBA and we engage with CMS [Centers for Medicare & Medicaid Services] to ensure communications regarding the use of NUEDEXTA accurately reflect FDA approved labeling," the company told CNN.