Publisher's Synopsis
The opioid epidemic has exacted a staggering human and financial cost in the United States over the past 20 years. Approximately 183,000 Americans died from prescription opioid overdoses between 1999 and 2015, with more than 15,000 Americans dying in 2015 alone.1 According to the Centers for Disease Control and Prevention (CDC), in 2015 "[t]he age-adjusted rate of drug overdose deaths in the United States in 2015...was more than 2.5 times the rate in 1999."2 Provisional 2016 statistics from the CDC also show that "[d]rug deaths involving fentanyl more than doubled from 2015 to 2016," and "deaths involving synthetic opioids, mostly fentanyls, have risen to more than 20,000 from 3,000 in just three years."3 In Missouri, the rate of prescription opioid-related inpatient hospitalizations and emergency room visits more than doubled from 187 per 100,000 to 424 per 100,000 between 2005 and 2014. 4 Similarly, Medicare Part D spending on commonly abused opioids increased 165% between 2006 and 2015, and one out of three Part D recipients received at least one prescription opioid in 2016 at a cost of $4.1 billion.5 In response to this crisis, Sen. McCaskill issued wide-ranging requests for documents related to opioid sales and marketing efforts to five major opioid manufacturers.6 These requests focused on internal estimates concerning the risk of opioid addiction, compliance audits and reports concerning sales and marketing policies, marketing and business plans, materials related to manufacturer payments to physicians and manufacturer-created physician presentations, funding of educational materials targeted to opioid-prescribing physicians, and funding for major pain advocacy groups and other groups. In response, the minority staff has received thousands of pages of internal company documents, including extensive materials from Insys Therapeutics. Drawing on these documents and other materials, this report provides new information regarding the significant efforts Insys has undertaken to reduce barriers to the prescription of Subsys, its powerful fentanyl product. These efforts include actions to mislead pharmacy benefit managers (PBMs) about the role of Insys in the prior authorization process and the presence of breakthrough cancer pain in potential Subsys patients. An internal Insys document suggests Insys apparently lacked even basic measures to prevent its employees from manipulating the prior authorization process and received clear notice of these deficiencies. In the case of Subsys patient Sarah Fuller, an audio recording reveals that an Insys employee repeatedly misled representatives of Envision Pharmaceutical Services to obtain approval for her prescription. The result, in the case of Ms. Fuller, was death due to allegedly improper and excessive Subsys use.
