Insys Therapeutics, Inc. has been hit with yet lawsuit over Subsys spray.
In a complaint filed last week in Arizona federal court, insurance giant Anthem Inc. accused Insys of bribing doctors and lying about patients’ diagnosis to secure fraudulent reimbursement for the powerful opioid painkiller.
Subsys is an oral fentanyl spray indicated solely to treat breakthrough pain in adult cancer patients who have developed a tolerance to opioids.
Last December, six former Insys executives were indicted by federal prosecutors for allegedly paying healthcare providers kickbacks to prescribe Subsys for non-cancer indications. Ten unnamed medical professionals were also indicted on charges that they conspired with an Insys “reimbursement unit” to write insurance claims that made it appear as though the medication was actually being used to treat cancer patients.
In June, a former Insys manager pled guilty and agreed to cooperate with the U.S. Department of Justice in its case against the six ex-company officials.
According to Anthem’s Subsys lawsuit, more than 50% of those using the oral fentanyl spray do not have cancer, making those prescriptions ineligible for insurance reimbursement. However, Anthem clams that it paid more than $19 million for inappropriate prescriptions due to the allegedly fraudulent schemes employed by Insys.
“But the harm inflicted by Insys’s conduct is not merely financial in nature,” the insurer argued in its filing. “Insys put Anthem’s members’ health at risk.”
Subsys spray is 50 times more powerful than heroin. According to the Anthem lawsuit, its side effects can include death by respiratory suppression.
The insurer’s complaint accuses Insys of fraud, negligent misrepresentation, unjust enrichment, civil conspiracy and engaging in deceptive, unfair and unlawful business practices.
Insys has also been named a defendant in a growing number of Subsys lawsuits filed on behalf of non-cancer patients who allegedly suffered overdoses and other complications related to its use. These plaintiffs claim that the company’s sales reps specifically targeted family doctors, internists, and general practitioners, even though they knew the doctors did not treat patients with cancer pain. The lawsuits further assert that, by the end of 2015, the vast majority of Subsys prescriptions were written for off-label indications.
In August 2015, Insys agreed to pay $1.1 million to the state of Oregon to resolve allegations that it deceptively promoted Subsys spray for non-cancer conditions. A similar lawsuit was settled by the state of New Hampshire in January 2017. Several other states are pursuing their own Subsys spray lawsuits.