The first report produced by the opioid investigation spearheaded by Senator Claire McCaskill, D-Mo., highlights the lengths Chandler, Ariz.-based Insys Therapeutics went to garner approval for its fentanyl-based painkiller Subsys.
Here are five things to know.
1. Subsys is intended to treat breakthrough pain in cancer patients. However, the report details an audio recording of a 2015 phone call in which an Insys employee misled a pharmacy benefit manager when attempting to obtain prior authorization for a Subsys prescription for a patient named Sarah Fuller, who was being treated for neck and back pain. In March 2016, Ms. Fuller died of a Subsys overdose.
2. In the beginning of the call, the Insys employee tells the PBM representative she's with the "doctor's office" and never clarifies she's working for Insys.
"When questioned as to whether Ms. Fuller does, in fact, suffer from breakthrough cancer pain, the Insys employee avoids responding directly and instead explains 'there's no code for breakthrough cancer pain,'" wrote the report's authors. "She then states again that the Subsys prescription is 'for breakthrough pain, yeah,' and the [PBM] representative discontinues this line of questioning. Toward the end of the call, the Insys employee states that Ms. Fuller is anticipated to remain on Subsys indefinitely."
To download the audio recording of the call, click here.
3. The 2015 call took place during a period when Insys executives were allegedly pressuring employees to increase their approval ratios for Subsys, according to the report.
"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," said Ms. McCaskill in an emailed release. "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."
4. Last month, Insys agreed to pay $4.45 million to resolve a 2016 lawsuit filed by Illinois Attorney General Lisa Madigan, alleging the company deceptively marketed its fentanyl-based painkiller Subsys, according to an Aug. 18 announcement.
5. In July, Ms. McCaskill expanded her investigation into the causes of the nation's ongoing opioid epidemic. Thus far, she has requested internal documents from McKesson Corp., AmerisourceBergen Corp., Cardinal Health, Mallinckrodt, Endo, Teva, Purdue Pharma, Janssen Pharmaceuticals, Insys, Depomed and Mylan.
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