The Centers for Medicare & Medicaid Services is asking insurers to be on the lookout for suspicious Nuedexta prescriptions, amid concerns that the antipsychotic medication is being used inappropriately to treat elderly dementia patients.
Marketed by Avanir Pharmaceuticals, Nuedexta is only approved to treat pseudobulbar affect (PBA), a rare condition that causes inappropriate emotional outbursts, such as laughing and crying. PBA occurs in less than 1% of Americans and is generally a secondary condition to other neurologic diseases or illnesses, such as ALS.
Nuedexta has not been shown to be safe and effective in treating other types of emotional liability that can commonly occur with Alzheimer’s disease and dementia, nor has it been well studied in the elderly.
In fact, Avanir’s only Nuedexta study focusing solely on patients with Alzheimer’s disease found that those treated with the drug were twice as likely to experience falls compared to those who received a placebo.
Despite this, a report that aired on CNN last year raised concerns that Avanir had undertaken aggressive measures to market the drug to nursing homes as a treatment for those suffering from dementia.
While doctors are legally permitted to use approved medications in any way they see fit, drug makers are legally forbidden from promoting drugs for indications that have not been cleared by the U.S. Food & Drug Administration (FDA).
Avanir states in its Nuedexta marketing materials that 39% of dementia patients suffer from the PBA. However, experts have told CNN that the rate is actually less than 5%.
Many of the Nuedexta prescriptions written for nursing home patients were purportedly intended to treat PBA. But CNN’s findings suggested that, in reality, the medication was being used to curb unruly behavior among those with dementia or Alzheimer’s disease.
An Ohio physician who was a top Nuedexta prescriber was evn accused of accepting kickbacks in exchange for prescribing the medication and fraudulently diagnosing PBA in order to get Medicare to cover the drug.
The Centers for Medicare & Medicaid Services has been concerned about inappropriate Nuedexta prescribing for some time.
Now CNN is reporting that the agency recently directed Medicare Part D sponsors to be on alert for suspicious Nuedexta prescribing patterns, reminding the insurers that they have a responsibility to confirm that drugs “are only covered when used for a medically-accepted indication.”
Several Medicare Part D insurers told CNN that they had already taken steps to monitor Nuedexta prescriptions.
For example, CVSHealth enacted a “Prior Authorization” requirement for Nuedexta in 2017, which, among other things, mandates that doctors provide documentation of a patient’s diagnosis in order to obtain coverage for the drug.
Aetna did the same in 2018, “following an analysis of Nuedexta use over the past few years.”
Priority Health said its Medicare plans would be adding a Prior Authorization requirement for Nuedexta in the near future. The company already bars Nuedexta coverage for dementia patients enrolled in its non-Medicare plans based on the lack of clinical testing for this population.
It’s not clear, however, how effective Prior Authorization requirements will be in curbing inappropriate Nuedexta prescribing, as CNN’s earlier reporting indicated that Avanir’s sales force coached doctors and nursing home employees on how to fight for Medicare coverage of the drug if it was initially refused.