- California's insurance commissioner on Tuesday sued AbbVie alleging a kickback scheme designed to convince doctors to prescribe the biopharma's top-selling biologic drug Humira over competing medicines.
- According to the lawsuit, AbbVie's efforts to keep patients on Humira included both illegal cash payments and gifts to prescribers as well as more the "sophisticated" provision of services like insurance processing to doctors who wrote prescriptions for Humira.
- More potentially damaging for AbbVie is the state's claim the company relied on a network of registered nurses — called 'ambassadors' and employed through a contractor — to downplay patient concerns with Humira and act as an intermediate between patients and their doctors. AbbVie contended in a statement that "the allegations are without merit."
By revenue, AbbVie's Humira (adalimumab) is one of the most commercially successful drugs currently on the market in the U.S. Its relentless double-digit sales growth over the past half decade has fueled AbbVie's rise since the company split off from Abbott in 2013.
Like other drugs in its class, Humira is used for a wide-range of chronic inflammatory conditions, carrying 10 separate indications on its Food and Drug Administration-approved label. That broad market opportunity has underpinned its growth, as has rising use of biologic medicines in the U.S.
The lawsuit filed Tuesday offers a competing narrative to that clean growth story — at least within the borders of California.
According to the complaint, AbbVie's gave illegal kickbacks to doctors over more than four years, between 2013 and August 2018. During that time, private insurers processed more than 274,000 claims for coverage of Humira treatment for California patients, paying out nearly $1.3 billion.
That makes the case the largest health insurance fraud case in the Department's history, the commissioners' office said.
"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," said California Insurance Commissioner Dave Jones in a Tuesday statement.
A whistleblower, who was employed as an nurse ambassador for more than a year, brought the case forward to the Department of Insurance.
Ambassadors were sent to the homes of patients prescribed Humira, providing care and assistance with things like insurance authorization and paperwork. Patients, the suit claims, were led to belief the ambassadors were an extension of the doctor's office. Instead, the nurses employed through the program were allegedly instructed to keep patients on Humira and refer questions and concerns to AbbVie, not physicians.
AbbVie contracted with QuintilesIMS, now known as Iqvia, to run the ambassador program.
Services provided by the ambassadors were valuable to doctors, who didn't have to dedicate staff to assisting patients with insurance authorization and other follow-ups.
"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," AbbVie said in a statement. "They in no way replace or interfere with interactions between patients and their healthcare providers."
California's Department of Insurance sees it differently, however.
"While providing significant value to the doctors' offices, Ambassadors' interactions with patients also served as a stand-in for what would otherwise be a conversation between patient and physician," the suit states. "These private nurses, paid by AbbVie, attenuate the direct relationship between the patient and their healthcare provider in troubling ways."
Much of the lawsuit covering the alleged "classic kickbacks" paid by AbbVie to doctors is redacted. A spokesperson for the State Department of Insurance said the redactions were required by the defendants (25 "Does" are named along with AbbVie) and other third parties.
The Department is seeking court approval for the rest of the lawsuit to be disclosed.
The suit seeks injunctive relief against AbbVie and assessment of three times the amount of each claim, as well as $10,000 for each fraudulent claim.
Shares in AbbVie sunk by nearly 3% Tuesday afternoon as markets reacted to news of the lawsuit.