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McCaskill Opioid Investigation Releases First Report Detailing Systemic Manipulation of Prior Authorization Process by Insys Therapeutics
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U.S. Senator Claire McCaskill, the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, today released the first product of her wide-ranging investigation into opioid manufacturers and distributors. “Fueling an Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization” describes the emphasis Insys Therapeutics put on boosting approvals for its highly addictive fentanyl drug Subsys, even for inappropriate, off-label uses, and details an audio recording in which an Insys sales representative misidentifies herself and uses language designed to circumvent the prior authorization process.

Insurers often employ this process to prevent the overprescription and abuse of powerful and expensive drugs like Subsys. While the Food and Drug Administration has only approved Subsys for the treatment of breakthrough cancer pain—cancer pain that persists despite attempted treatment with other opioid medications—an internal document obtained by McCaskill shows that Insys lacked measures to prevent its representatives from manipulating the prior authorization process and gaining approval for Subsys treatment of non-cancer conditions like back pain, fibromyalgia and migraine headaches.

“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. “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.”

As part of its investigation, the minority staff received an audio recording of conversations between an Insys employee and pharmacy benefit manager representatives related to a Subsys prescription for Sarah Fuller, who later died from an alleged fentanyl overdose. This recording suggests the Insys employee in question repeatedly misled Envision Pharmaceutical Services to obtain approval for Ms. Fuller’s Subsys treatment—heavily implying she was employed by the prescribing physician and misrepresenting the type of pain the patient was experiencing.

The call occurred during a period in which Insys was aggressively pressuring its employees to increase their ratio of approvals. Employees reportedly received significant financial incentives and management pressure—including quotas and group and individual bonuses—to boost the rate of Subsys authorizations. “In an internal presentation dated 2012 and entitled, “2013 SUBSYS Brand Plan,” Insys identified one of six “key strategic imperatives” as “Mitigate Prior Authorization barriers,” the report notes. “On a later slide, the company identified several tasks associated with this effort, including “Build internal [prior authorization] assistance infrastructure,” “Establish an internal 1-800 reimbursement assistance hotline,” and “Educate field force on [prior authorization] process and facilitation.”

Subsys—a fentanyl sublingual spray product approved by the Food and Drug Administration in 2012 to treat breakthrough cancer pain—can cost over ,000 per month, and proved incredibly successful financially after its introduction to the market. Insys had “the best-performing initial public offering in 2013,” and, over the next two years, revenues tripled and profits rose 45%. The value of company stock increased 296% between 2013 and 2016.

McCaskill has previously requested information related to sales and marketing materials, internal addiction studies, details on compliance with government settlements and donations to third party advocacy groups from major opioid manufacturers. She recently expanded her investigation, requesting documents and information from opioid manufacturers Mallinckrodt, Endo, Teva, and Allergan, while a request to McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., focused on their distribution of opioid products.

When McCaskill was ranking member of the Permanent Subcommittee on Investigations, she joined Subcommittee Chairman Rob Portman to launch an investigation into the role Medicare Part D entities, private insurers, and pharmacy benefit managers play in detecting, reporting, and addressing opioid abuse, resulting in the in-depth report, “Combatting the Opioid Epidemic: A Review of Anti-Abuse Efforts in Medicare and Private Health Insurance Systems.”

Visit www.mccaskill.senate.gov/opioid-investigation to learn more about McCaskill’s investigation.

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Team Fibromyalgia prepping for exchange at TS 40 – 6/26/09

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