For years, the Centers for Medicare & Medicaid Services has been hearing concerns that laughing drug Nuedexta was being aggressively pushed by maker Avenair Pharmaceuticals and some doctors for questionable use on dementia patients. Now, the CMS is asking insurers to be on alert for that kind of suspicious prescribing pattern and to let the agency know ASAP if it has concerns.
The drug alert, first reported on by CNN, said that CMS is “monitoring the increased utilization of the drug Nuedexta” after allegations of potential use “for non-medically accepted indications.”It reminds Medicare Part D plan sponsors they have a responsibility to ensure that drugs “are only covered when used for a medically-accepted indication.”
Avanir, in a statement, told CNN that it "is committed to the safe, effective use of Nuedexta for the treatment of patients with PBA." The company claims its promotional materials, are reviewed both internally and by the FDA.
"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 drug, which is one of only two marketed by California-based Avanir Pharmaceuticals, is approved by the FDA for treating pseudobulbar affect disorder (PBA), a neurological condition characterized by sudden outbursts of uncontrollable laughter or crying seemingly unrelated to mood.
Avanir, a unit of Japan’s Otsuka Holdings, has said that many dementia patients suffer from PBA, but regulators are concerned that Medicare may be paying for the drug for unapproved and potentially fraudulent uses.
An investigation by CNN found that sales of Nuedexta grew 400% in four years to reach $300 million in 2016, and that half of the pills Avanir has sold since 2012 have gone to long-term care facilities even though prescribing information acknowledges the drug has not been extensively studied in elderly patients. One study of people with Alzheimer’s, found it seemed to increase the risk of falling.
CNN said it found that doctors often prescribed Nuedexta to dementia patients in nursing homes, citing a PBA diagnosis, when instead it was being prescribed to control unruly behaviors. Some of those heavy prescribers have been paid by Avanir for speaking about the drug.
One California psychiatrist, for example, received $500,000 in cash, travel and meals from Avanir and Otsuka in the three years ending in 2016, CNN’s story alleged.
To head off such uses, the CMS alert suggested insurers put utilization safeguards in place like preapproval reviews. It also invites providers to give the FDA “feedback on any actions you have taken regarding the drug Nuedexta…”