US drugmaker allegedly pushed opioid sales using dodgy tactics

Employees of Insys Therapuetics allegedly used dubious tactics with insurers and pharmacy benefit managers (PBMs) to get reimbursement approval for their fentanyl spray (Subsys), which included posing as doctor's office employees and being deceitful about individual patients' cancer status, according to a new congressional report issued on 6 September by US senator Claire McCaskill.

Subsys, a powerful synthetic opioid, was approved in 2012 for breakthrough pain in cancer patients who are also on other, around-the-clock opioids but who experience inconsistent relief.

Following the FDA approval, only about 30 per cent of Subsys prescriptions were being approved for reimbursement by payers, the report said.

The report added that the company set up a unit of employees to boost the  success rate with the "prior authorisation" process, an insurance industry mechanism designed to prevent excessive use of expensive drugs such as Subsys.

The company's efforts apparently paid off as revenues tripled, and profits shot 45 per cent after its initial public offer of stock in 2013. Between 2013 and 2016, the value of the company stock increased 296 per cent.

The report details the process in which agents systematically convinced insurers to pay for a highly-addictive opioid cancer pain drug for patients who did not have cancer.

An investigation is underway into the manner in which the company allegedly tricked insurance companies into covering the costs of a sprayable form of fentanyl called Subsys.

A recording of a call in which an Insys employee contacts an insurance company to obtain prior approval is revealing. An Insys employee contacts the insurance company to obtain prior approval and, using a script, tries to pass off as calling on behalf of the doctor's office. The employee claims to be ''with'' the patient's doctor's office and pretends to be flipping through the patient's transcript and says loudly that Subsys is ''intended for the management of breakthrough cancer pain.'' Having established the full phrase, the Insys rep then says the patient has ''breakthrough pain.''  Two different employees from the insurance company pressed the Insys employee about whether the drug was being prescribed for ''breakthrough cancer pain'' and each time the rep's answer left out the word cancer.

The ploy worked on numerous occasions and in one case, the representative was calling on behalf of a woman from New Jersey named Sarah Fuller, who did not have cancer, but died of Subsys overdose in 2016.