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AbbVie is accused of paying kickbacks, using a stealthy network of nurses to promote Humira

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A logo sign outside of an office building occupied by AbbVie, in Redwood City, California, on December 31, 2014. Photo Credit: Kristoffer Tripplaar/ Sipa USA

In a wide-ranging scheme, AbbVie (ABBV) used a combination of old-fashioned kickbacks to doctors and a stealthy network of nurses to illegally boost prescriptions of its best-selling Humira treatment, according to a lawsuit filed on Tuesday by the California insurance commissioner.
Over a five-year period, the drug maker offered physicians a familiar menu of tempting items, from cash, meals and drinks, to gifts and trips, along with patient referrals, in hopes they would write more prescriptions for its Humira rheumatoid arthritis treatment, a $12.3 billion seller in the U.S. last year.
However, AbbVie also engaged in an allegedly more nefarious practice in which registered nurses were hired to act as “ambassadors” to visit patients at home and help with administering the drug, but instead were used to ensure that prescriptions were continually refilled, the lawsuit stated.
“AbbVie spent millions convincing patients and health care professionals that AbbVie Ambassadors were patient advocates. In fact, the ‘Ambassadors’ were Humira advocates hired to do one thing: keep patients on a dangerous drug at any cost,” California Insurance Commissioner Dave Jones said in a statement. “In this case, patient care was traded for $1.2 billion in ill-gotten gains.”
From 2013 through 2018, some 274,000 claims for Humira prescriptions were submitted to private insurers, which paid out more than $1.2 billion, according to the lawsuit. This amounts to the largest health insurance fraud case in department history, Jones said.
An AbbVie spokeswoman sent us this: “We believe the allegations are without merit. AbbVie operates in compliance with the many state and federal laws that govern interactions with healthcare providers and patients. AbbVie provides a number of support services for patients, once they are prescribed Humira, that both educate and assist patients with their therapy, including nursing support, and these resources are beneficial to patients dealing with a chronic condition. They in no way replace or interfere with interactions between patients and their healthcare providers.”
The allegations were initially raised by Lazaro Suarez, a registered nurse who worked for a contractor — QuintilesIMS, which is now part of IQVIA — that was hired by the drug maker to develop the network of nurses. Suarez trained nurses who visited Humira patients around the U.S., although these nurses also accompanied AbbVie sales reps on visits to physician offices.
“While providing significant value to the doctor offices, Ambassador interactions with patients also served as a stand-in for what otherwise would be a conversation between patient and physician. These private nurses, paid by AbbVie, attenuate the direct relationship between the patient and their health care provider in troubling ways,” the lawsuit claimed.
How so? The nurses gained access to patients and “capitalized on their vulnerability” in becoming familiar with a medication that requires assistance to administer. Beyond ensuring that patients remained on the drug, the nurses allegedly were instructed to report any patient questions or complaints to AbbVie, rather than individual physicians.
Rheumatology, gastroenterology, and dermatology practices generally employ nurses, prior authorization experts, and other staff to provide insurance advice and counseling to patients. As the lawsuit noted, these services are time consuming and costly for physicians, whose staffs “command substantial salaries” for doing this work.
And so, AbbVie allegedly provided “professional goods and services” to physicians that included free insurance processing and prior authorizations assistance, medical practice management hardware and software, and marketing assistance, according to the lawsuit. These saved “physicians valuable staff time and resources.”
The lawsuit, by the way, was heavily redacted because AbbVie argued much of the information was confidential, or trade secrets, according to a spokeswoman for the California insurance department which, she added, hopes to convince the court that the redactions should be lifted.
AbbVie has often been scrutinized for its strategies to bolster Humira, given the sales that the drug generates. The company has filed dozens of patents – sometimes known as a patent thicket – to protect the drug from competition, many of which do not expire until 2022. A new analysis found that AbbVie filed 89 percent of those patents since winning regulatory approval in the U.S.
This is not the first time that a drug maker allegedly used nursing staffs to improperly promote medicines. Over the past year, at least four other drug makers — Gilead Sciences (GILD), Amgen (AMGN), Eli Lilly (LLY) and Bayer Pharmaceuticals (BAYRY) — hired nurses to talk up treatments to doctors and their patients, an arrangement that purportedly violated federal kickback laws, according to lawsuits (see here and here).
The companies avoided concerns that sales reps might get little to no face time with doctors and simultaneously helped save physicians from the expense of providing follow-up care, according to the lawsuits. The approach is sometimes known as “white coat marketing,” which the lawsuit noted is considered problematic by authorities because it may blur trust between doctors and patients.

Originally posted on statnews.com