Sen. Claire McCaskill's report, released Wednesday, highlights past efforts at Insys to bypass prior authorization "barriers" to expand the reach—and sales—of opioid painkiller Subsys. The drug is approved to treat breakthrough pain from cancer, but numerous lawsuits and investigations center over the company's marketing efforts outside of the labeled indication.
In one instance, Sen. McCaskill's report details a phone call from an Insys employee to a pharmacy benefit manager, during which the undisclosed Insys employee said he or she was calling from a doctor's office. The Insys employee also didn't give the full picture on the patient's source of pain. That patient, Sarah Fuller, passed away last year from an alleged overdose; her family has since filed a lawsuit against the drugmaker and other parties.
The prior authorization process requires patients’ physicians to secure coverage for certain drugs that could be dangerous or that have cheaper alternatives. The report says Insys employees received “significant financial incentives and management pressure—including quotas and group and individual bonuses—to boost the rate of Subsys authorizations.”
In response to a request from the senator's office, new Insys CEO Saeed Motahari said his company has overhauled its staff from previous years and replaced top management.
Further, the company has "actively taken the appropriate steps to place ethical standards of conduct and patient interests at the heart of business decisions," the helmsman wrote to Sen. McCaskill. He joined Insys four months ago.
Initally, Sen. McCaskill requested information from Johnson & Johnson, Depomed, Mylan, Insys and Purdue as part of her opioid investigation. She has since requested information from Mallinckrodt, Endo, Teva and Allergan. The senator is also examining distribution practices from McKesson, AmerisourceBergen and Cardinal Health.
Sen. McCaskill's report is the latest look into promotional tactics at an embattled drugmaker that has weathered scrutiny on its Subsys marketing for years. After arresting lower-level workers, the Justice Department last year charged former CEO Michael Babich and a group of other execs. In July, Babich’s wife, a former saleswoman at the drugmaker, pleaded guilty to a kickback scheme on the med.
Last week, Arizona filed its own lawsuit alleging fraudulent marketing to boost sales for the painkiller fentanyl.http://www.fiercepharma.com/pharma/senator-s-report-digs-into-insys-promotional-tactics-for-subsys
