Nuedexta is the only FDA approved drug to treat pseudobulbar affect (PBA), a rare disorder affecting less than one percent of the population, according to a CNN investigation.
The Centers for Medicare & Medicaid Services and the U.S. government is now warning insurers to be aware of unethical uses of the drug. It has had an enormous jump in financial success from 2012 to 2016 when the number of pills dispensed to long-term care facilities rose approximately 400 percent.
Data from IQVIA reveals that more than 50 percent of the pills since 2012 have been going to long-term care facilities. IQVIA, is a leading global provider of information, innovative technology solutions and contract research services focused on using data and science to serve healthcare clients.
Avanir Pharmaceuticals, the maker of the pills, generated over $300 million in total sales for Nuedexta in 2016. The pharmaceutical company claims many dementia patients suffer from PBA, as stated in CNN, but cases of alleged fraudulent diagnosis to secure Medicare coverage has been reported.
According to the investigation, there is economic promise in expanding the drug’s market to elderly patients suffering dementia and/or Alzheimer’s disease. A high volume of prescriptions in nursing homes raises concerns as the drug maker’s prescribing information states that Nuedexta’s effects have not been widely studied in older patients.
Diagnosing a patient under false pretenses in order to receive Medicare Part D funding is fraudulent. An Ohio doctor is under government investigation for “allegedly receiving kickbacks for prescribing the drug and fraudulently diagnosing patients with PBA in order to secure Medicare coverage,” as stated in the investigation.
Complaints have been filed since the beginning of Nuedexta’s success when BlueCross BlueShield of Arizona wrote a “strongly-worded” letter to Avanir stating:
“We believe that the manufacturer appears to be marketing Nuedexta far beyond the scope of the clinical evidence.”
A more recent complaint from 2016 stated:
“I am concerned with the off label promotion of Nuedexta for diagnosis other than PBA.”
The person who filed the complaint was not disclosed in the article.
To read the full investigation conducted by CNN, click here.
To read more about complaints filed by insurers and Medicare part D coverage, read this supporting article by CNN.
For more information regarding the actions of CMS, visit FiercePharma.