Drug company Insys Therapeutics sought to bypass the normal approval process to have its highly addictive and potent fentanyl opioid Subsys provided to patients who didn’t need it, according to a Senate Democratic report.
Sen. Claire McCaskill of Missouri, the top Democrat on the Homeland Security and Governmental Affairs Committee, presented the findings during a press conference Wednesday, and played an audio recording of an Insys employee asking pharmacy benefit manager Envision Pharmaceutical Services to order Subsys for a patient named Sarah Fuller.
Normally, a doctor’s office would call a pharmacy benefit manager to ensure a certain drug is used. But the audio allegedly revealed that the Insys employee claimed to be from a doctor’s office in a push to ensure Subsys was prescribed.
According to McCaskill, this occurred repeatedly and Fuller is reported to have died of a fentanyl overdose.
Certain high-risk drugs like Subsys need additional approval by a pharmacy benefits manager before a claim can be sent to an insurer. The drug can cost as much as $20,000 a month and is supposed to be approved only for breakthrough cancer pain, meaning pain that persists after a patient has tried other opioids. Fuller did not have cancer but was being treated for back pain and fibromyalgia.
Insys didn’t have measures in place to prevent representatives from manipulating the authorization process so it could get approval for Subsys for the treatment of non-cancer conditions like back pain, fibromyalgia or migraines. The company pressured its employees to get more approvals for the drug by setting up bonuses and quotas, the report found.
“There is extensive evidence that Insys aggressively pressured its employees and the entire medical system to increase the use of a fentanyl product during a national epidemic that was taking the lives of tens of thousands of Americans a year in order to make more money; it’s hard to imagine anything more despicable,” McCaskill said in a statement. “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.”
McCaskill’s office received the Insys documents as part of a larger request her office sent to several opioid makers for sales and marketing practices. She said other documents were being reviewed to determine how widespread the practice was.
She is aiming to determine the role that opioid makers have had in the opioid crisis that also involves fentanyl. Drug deaths involving synthetic fentanyl, which comes from China by way of Mexico, doubled from 2015 to 2016, and have risen from 3,000 to more than 20,000 in three years, according to data from the Centers for Disease Control and Prevention.
McCaskill said during a press conference that Congress needed to examine different aspects of the fentanyl problem through work with law enforcement and the Department of Health and Human Services. When asked about whether the drug should be recalled, she said she would have to consult with oncologists to determine her position to determine whether “its therapeutic value is worth the price that has been paid.”
An inquiry sent to Insys about the report was not returned.
