Six former Insys Pharmaceuticals executives accused of bribing doctors to prescribe Subsys spray will head to trial on October 18th in Massachusetts federal court.
Subsys is a spray version of fentanyl, a highly-addictive opioid painkiller that is significantly more powerful than heroin. It is indicated solely for the treatment of breakthrough pain experienced by adult cancer patients who have developed a tolerance to opioid painkillers.
The six Insys executives were indicted in December, after the U.S. Department of Justice accused them of 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 federal prosecutors in their case against the six ex-company officials.
On Wednesday, U.S. Senator Claire McCaskill, a Democrat from Missouri, released a new report detailing the methods Insys allegedly used to induce doctors to prescribe Subsys spray.
Because Subsys is relatively expensive, most insurers will not cover the drug without prior authorization. To obtain authorization for non-cancer prescriptions, Insys employees would call insurers using a carefully worded script intentionally designed to leave the impression that they were calling from a physician’s office. The script also allowed employees to suggest that patients being prescribed Subsys had cancer without explicitly saying so.
Insys also masked its outgoing phone number so that it wouldn’t appear on caller IDs, and “reportedly provided a 1-800 number manned by another Insys representative — instead of contact information for the prescribing physician,”
“Their attempts to manipulate the prescription approval process for this drug appear to have been systemic, and anyone responsible for this manipulation deserves to be prosecuted,” Senator McCaskill said upon the report’s release.
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.