BOSTON
(Reuters) - Insys Therapeutics Inc sought to manipulate insurance
payment approval for an opioid cancer pain drug called Subsys even if
for inappropriate uses, according to a U.S. Senate report on the opioid
crisis released on Wednesday.
The report,
released by Democratic Senator Claire McCaskill, said those efforts led
to an Insys employee making misleading statements to get insurance to
cover a prescription for a woman who according to a lawsuit died after
taking Subsys.
The report was the first by
McCaskill, the ranking Democrat on the U.S. Senate Homeland Security and
Governmental Affairs Committee, to flow out of her investigation into
drugmakers’ roles in the national opioid addiction epidemic.
The
report came amid a series of federal and state investigations centered
on the marketing of Subsys, an under-the-tongue spray intended for
cancer patients that contains fentanyl.
Fentanyl is a man-made opioid that is 100 times more powerful than morphine.
In
December, federal prosecutors in Boston charged six former Insys
executives and managers, including former Chief Executive Michael
Babich, with engaging in a scheme to bribe doctors to prescribe Subsys.
They have pleaded not guilty.
McCaskill’s
report said that Chandler, Arizona-based Insys lacked measures to
prevent employees from manipulating the process insurers and pharmacy
benefit managers use to deter over-prescription by requiring
pre-approval of medicines.
The report noted
that in June, Elizabeth Gurrieri, a former manager of reimbursement
services for Insys, pleaded guilty to conspiring to defraud insurers
into paying for Subsys.
It also cited the case
of Sarah Fuller of New Jersey, who died in March 2016 after seeking
treatment two years earlier for conditions including back pain,
according to a lawsuit her family filed against Insys.
McCaskill’s
report said an audio recording showed that an Insys employee misled a
pharmacy benefit manager to obtain approval for Fuller’s prescription,
saying she was calling from a doctor’s office and that the drug was to
treat cancer pain.
“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 said.
Insys
in a statement said it disagreed with “certain characterizations” in
McCaskill’s report but agreed the “opioid epidemic must be addressed.”
In
a Sept. 1 letter accompanying McCaskill’s report, Insys CEO Saeed
Motahari said the company’s former employees’ “mistakes and unacceptable
actions” were not indicative of those currently working for Insys.
“Over
the past several years, Insys has actively taken the appropriate steps
to place ethical standards of conduct and patient interests at the heart
of our business decisions,” he said.
Reporting by Nate Raymond in Boston; additional reporting by Yashaswini Swamynathan; Editing by Leslie Adler and Andrew Hay